outline for birth control research paper

Birth Control - Free Essay Samples And Topic Ideas

Birth control, a critical aspect of reproductive health, enables individuals and couples to plan if or when they want to have children. Essays might explore the various methods of birth control, the history of birth control advocacy, and the societal implications of accessible contraception. Discussions could delve into the challenges faced in promoting birth control in different cultural or religious contexts, and the impacts of birth control on gender equality, economic stability, and public health. They might also discuss the controversial political and moral debates surrounding birth control, and the role of education in fostering informed decisions regarding reproductive health. We have collected a large number of free essay examples about Birth Control you can find at Papersowl. You can use our samples for inspiration to write your own essay, research paper, or just to explore a new topic for yourself.

Effects Birth Control have on Women

Most believe that birth control serves one purpose to prevent pregnancy. While it's very effective compared to other forms of contraceptives, the effects aren't just limited to pregnancy prevention. Its also known to be used to help treat other health concerns such as menstrual relief, skin changes, and more. Birth control has different side effects on women because of different hormone levels and each birth control carries different level of progestin and/or estrogen. Given the grueling horror stories we hear […]

The Morality of Birth Control

American Educator, birth control activist, sex educator, writer, and nurse Margaret Sanger has written numerous pieces about women empowering. One of her most popular speeches, "The Morality of Birth Control," is intended for women and America as a nation. It is spoken for women that feel like they have no way out of the risks of sex, including pregnancy. It can also be intended for men, in order to be aware of what women go through and that they will […]

The Importance of Sex Education

“This is the real world, and in the real world, you need protection,” – Cherie Richards. Students, specifically teenagers, need correct information and the right resources to learn, help and protect themselves. When students have no knowledge whatsoever, they turn to media or even pornography to get information because their parents aren’t open enough about sex or the topic. Sex education is a type of teaching where students are taught about sexuality, contraceptive methods, how to prevent sexually transmitted diseases, […]

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Should Birth Control be Free?

Family planning is used by 57 percent of married or in-union women of reproductive age according to a study conducted in 2015 by the United Nations. This displays the impact that contraceptives have worldwide and creates a question of equality within health care, "Is birth control a fundamental right or a privilege?" Even though the use of birth control is increasing, a study by the UN estimates that over 214 million women are not using safe and effective family planning […]

The Effects of Nicotine on Child Development and Birth Control

Why is nicotine bad on physical development? Nicotine and other poisonous chemicals in tobacco products cause, diseases, heart problems, and cancer, because it makes it difficult for blood to flow throughout the body, making you tired and cranky. Not only does it harm development and the body but robs you of your money, people find themselves addicted and pay for more, these products can add up to be expensive. Your body knows you shouldn't be using it when your lungs […]

An Issue of Women’s Reproductive Rights

We hold these truths to be self-evident: that men and women are created equal (Elizabeth Cady Stanton). In America this has been the basis of what our nation stands for. It is stated that every citizen has the right to equality that shall not be stripped away, in many cases that is not true. Whether man or women you should possess the same rights, but more often than not the women's rights are taken away. There are many instances in […]

Moral Issues Birth Control

Birth control is a sensitive topic in society, especially the Catholic faith. The Catholic faith has taught that birth control is a sin for many reasons. In 1968, Pope Paul VI issued his landmark encyclical letter Humanae Vitae which reemphasized the Church's constant teaching that it is always intrinsically wrong to use contraception to prevent new human beings from coming into existence (Carr, 2004). The Catholic Church has always taught that preventing procreation in any way is wrong and that […]

The Right to Birth Control

According to the National Health Statistics Reports, in the United States as of 2013, 99 percent of sexually active women aged 15-44 have used at least one contraceptive method (Contraceptive Use in the United States). This means that of the large population of women having sexual intercourse, almost all of them use or have used contraception of some sort in their lives. The accessibility and high rates of usage were not always that high. Previous to 1972, women had substantial […]

Abortion on Teens should be Abolished

Am sure we have all heard of the girl meets boy story, where the girl falls in love with the boy despite receiving plenty of warnings and criticism from any person who has ever mattered in the girl's life. Everything is merry and life is good for the girl until one day she realizes she has missed her period and rushes to her man's home telling herself that everything will be okay. Reality checks in, hard, when the boy declines […]

One to Two Lines: Decoding Birth Control Effectiveness and Choices

Abstract This paper illustrates the different types of contraceptives available to the public. We studied each type of birth control and show the reader which method best suits their needs for protection. Throughout this paper, we cover the pros and cons of each birth control measure to give the reader a comprehensive understanding of each method. This paper discusses contraceptives available for both men and women. STDs, teenage pregnancy, and hormonal imbalances can be common if birth control is used […]

Birth Control a Mixed Issue Today

Birth control has become a mixed issue today in our society. The types of birth control that can be used vary , while the side effects aren't being explained to the women and our younger generation who use them .The most common birth controls are the pill and Depo-Provera . Both birth controls were made to prevent pregnancy but both have horrible side effects that can mess with your body in the long run . In 1960-1970 the first clinical […]

The Second Wave of Feminism

The Second Wave of feminism, also known as the Women’s Movement, gave women greater personal freedoms, such as the right to work outside of the home, political freedoms, family, and reproductive rights. The second wave also drew attention to domestic violence and rape in relationships/marriages. Even though the years of The Second Wave Movement is often argued about, it is said that the second wave officially started in 1963 and ended in the early 1980s. The Women’s Movement was influenced […]

Birth Control in Many Different Forms

According to HHS.gov, every year out of 100 women using birth control, only about 5 to 9 may become pregnant due to not using birth control correctly. Around 1960, the first oral contraceptive known as Enovid, was approved by U.S. Food and Drug Administration (FDA) as a use of contraception. (Thompson). In 1968, the FDA approved intrauterine devices (IUDs). (Thompson). In 1972, the Supreme Court legalized birth control for all citizens of the U.S. (Thompson). In the 1980s, pills with […]

Birth Controll Pills

Far and away the most common method of birth control today is the birth control pill. The pill contains a combination of two female hormones, estrogen and progestin, it prevents the body from releasing an egg from the ovary and it also thickens up the mucus at the cervix. In addition, the pill is harmless and in fact, birth control pills are even safer for teenagers than for adults. However, the pill is not relatively easy to obtain, it requires […]

Birth Control: Precaution or Deleterious Action?

Birth control, known for preventing pregnancy, takes various forms: pills, sponges, vaginal rings, patches, condoms, and more. It was legalized by the Supreme Court during the Baird V. Eisenstadt case in 1972 (Thompson). Some women were ecstatic when it was legalized, seeing it as a way to have control over their lives—not only in terms of pregnancy but also in regulating their menstrual cycles. I was in the seventh grade when I first encountered birth control. Like other girls, I […]

Birth Control Coverage a Woman’s Demanded Right

A huge part of being a woman is motherhood. It is a very precious concept that should be considered whenever a woman is capable of caring for a child emotionally, physically, and financially. However, sometimes accidents happen. Birth control is one of the most efficient and responsible solutions to avoid unwanted pregnancy especially in teens. In today's society, there has been an increase of birth control usage in the United States. Mostly all women of age to conceive who have […]

Abstinence-only Sex Education

The United States government claims that abstinence-only is the best form of sexual education, however I believe that abstinence-only programs are counterproductive. They ignore contraceptive effectiveness, disregard spreading of sexually transmitted infections, and prevent the exploration of sexuality. Abstinence-only sexual education is ideologically skewed because it focuses on teaching only about abstinence and how to maintain it. Rather than providing information about safe ways to have intercourse, it is encouraged to abstain from all sexual activities until marriage. Emphasizing abstinence […]

Birth Control Implant Implanon

Birth control implants are devices that go under the skin of a woman, they release a hormone that prevents pregnancy. Two similar implants available in the US are Implanon and Nexplanon, which is gradually replacing Implanon. Each implant is a plastic stick the size of a match. The bars contain a form of the hormone progesterone called etonogestrel. What To Expect In The Doctor's OfficeYour doctor or other health care provider will inject medicine to put your skin on the […]

Birth Control for Minors

Introduction According to the CDC, even though United States is one of the top industrial nations in the world, our nation has the most teenage pregnancies, in the latest statistics ""in 2017 a total of 194,377 babies were born to teenage mothers age 15 to 19 years old. (CDC, 2019). Unfortunately, about 50% of these teen Moms will drop out of high school and many will live in poverty. Despite these high rates of births, the question and dilemma is […]

Birth Control: a Necessity or Luxury?

Sex. Birth Control. Sex Ed. These are all words that tend to make most people uncomfortable. But, why? What is the stigma behind these small words and phrases that tends to make people jump at the mention? The reality is, most people are under-educated on these phrases. Most don’t realize how much of an impact birth control can have on people’s lives. It allows safe sex, choosing when you get to have children, relief from period pain, acne, polycystic ovary […]

Birth Control Education for Middle School Aged Adolescents

Sex is the tool used by humans to procreate. Reproduction is not the only way that sex benefits the human race. Sex has always been sold as a ware, considered a de-stressing pastime, or a physical way for two romantic partners to display their love for one another in an intimate fashion. Young adults who are only beginning to understand their bodies and the many things they can do with them tend to be illiterate in sexual education. Instead of […]

Abortion is a Choice

Abortion is a choice, but that doesn’t mean that it’s the right one. In October of 1997 a woman was told by a hospital physician that she needed to have an abortion because her son had Choroid Plexus Cysts caused by a defect in his 18th paired chromosome. They told her he wouldn’t be normal, and that if she carried him to term; he would have severe disabilities. The doctors told her that her son would be incapable of doing anything […]

Balancing Acts: Navigating the Complexities of Birth Control Choices

Birth control holds a multifaceted position in the realm of reproductive health, providing individuals with the autonomy to navigate their bodies and family planning choices. Its efficacy in preventing unintended pregnancies has earned widespread acclaim, yet birth control methods present a spectrum of advantages and drawbacks, exerting influence over personal, social, and health-related dimensions of individuals' lives. Pros of Birth Control: Empowering Family Planning: Birth control stands as a cornerstone in empowering individuals to plan and space pregnancies, offering greater […]

Why Birth Control is Important: Addressing Teen Pregnancy and STD Rates

The United States ranks first in high teen pregnancy rates and sexually transmitted diseases. Since 2011, 400,000 girls between the age of 15-19 years old have given birth every year (Stanger-Hall, and Hall). So why is nothing being done about it? Why is the government putting these programs that are not helping the statistics go down in place? The Controversy of Abstinence-Only Education While some may argue abstinence-only education is the best way to keep teens and even middle schoolers […]

Analysis of the Affordable Care Act and the Birth Control Pill

Obamacare was signed into law in March 2010. The law covers various types of health plans, benefits, and services. Just years ago millions of women were paying for or couldn't afford birth control. Now, "an estimated 27 million women are currently benefiting from Obamacare's no-cost services” (Ressler). Birth Control is an ongoing debate on whether the pill itself should be covered for by taxes due to peoples rights and beliefs about its use. Another issue about the contraception is who […]

Abortion and Adoption

Abortion is not as simple as walking into a medical office and having the procedure performed. Although Roe v. Wade made abortion legal in the United States in 1973 women often have to deal with judgment from others including not only protestors but significant others and family members, choosing between abortion and adoption, emotional stress possibly from the reason they are needing an abortion, physical complications, as well as state governments trying to take away their right to have an […]

A Minor’s Decision

A Minor’s DecisionIf a minor can make the decision to have sex, then they should be able to be allowed to make their own decision concerning the use of birth control. It is your own body, so only you can decide what happens to it. Even though it’s your child, the parents shouldn’t have a say in whether they want birth control or not because it’s not their decision. A minor can choose to discuss it with their parents if […]

Adolescents in the United States

Adolescents in the United States have an unlimited amount of access to a multitude of the different types of mass media, including television, music, movies, and the Internet practically social media sites. The majority of these adolescents tend to utilize their time focusing on the media rather than the education they receive in the school or their parents. The majority of this content idealizes being sexually active, including different types of sex messages with dialogue and content. Few of these […]

Eugenics Continued after World War II

Francis Galton first coined the term eugenics as a philosophy to improve humanity by encouraging people with presumed desirable traits to have children, while discouraging those with unwanted' attributes to refrain from reproducing. Galton's theory developed with the assistance of his increasingly famous second cousin, Charles Darwin, and his theory of evolution (Galton). Eugenics theory gained further popularity throughout the 20th century, captivating the attention of medical and government leaders. This lead to the eventual artificial replication of the survival […]

Abortion is an Exceptionally Touchy Issue

Abortion is an exceptionally touchy issue. Numerous individuals are continually discussing whether abortion should be permitted or not. Pro-life and Pro-choice has been a controversial topic since the early 1820s. A few people think fetus removal is extremely terrible and that it should not be permitted by any means. Although I may not personally participate in abortion,I believe that abortion should be a women’s choice with her body because, America is over populated and underfunded, she knows what type of […]

How to Write an Essay About Birth Control

Understanding the concept of birth control.

Before writing an essay about birth control, it's important to understand what birth control is and the various methods available. Birth control, also known as contraception, refers to methods or devices used to prevent pregnancy. Start your essay by explaining the different types of birth control methods, including hormonal contraception (like pills, patches, and injections), barrier methods (such as condoms and diaphragms), intrauterine devices (IUDs), and natural methods. Discuss the effectiveness, accessibility, and suitability of these methods for different individuals. It’s also crucial to explore the historical development of birth control and its role in the sexual and reproductive health movement.

Developing a Thesis Statement

A strong essay on birth control should be centered around a clear, concise thesis statement. This statement should present a specific viewpoint or argument about birth control. For example, you might explore the impact of birth control on women's health and rights, analyze the social and political challenges surrounding access to contraception, or argue the need for improved sex education in schools. Your thesis will guide the direction of your essay and provide a structured approach to your topic.

Gathering Supporting Evidence

To support your thesis, gather evidence from a variety of sources, including medical studies, public health data, and historical texts. This might include statistics on birth control usage, research findings on the health benefits or risks associated with various contraception methods, or analysis of policy changes affecting birth control access. Use this evidence to support your thesis and build a persuasive argument. Remember to consider different perspectives, including cultural and ethical dimensions of birth control.

Analyzing the Impact of Birth Control

Dedicate a section of your essay to analyzing the impact of birth control on society. Discuss how birth control has transformed women’s health, empowerment, and socioeconomic status. Consider the role of birth control in family planning, population control, and sexual health. Explore the challenges faced in accessing birth control, such as legal restrictions, cultural stigmas, or economic barriers.

Concluding the Essay

Conclude your essay by summarizing the main points of your discussion and restating your thesis in light of the evidence provided. Your conclusion should tie together your analysis and emphasize the importance of birth control in contemporary society. You might also want to suggest areas for future research or action needed to improve access to and understanding of birth control.

Reviewing and Refining Your Essay

After completing your essay, review and refine it for clarity and coherence. Ensure that your arguments are well-structured and supported by evidence. Check for grammatical accuracy and ensure that your essay flows logically from one point to the next. Consider seeking feedback from peers, educators, or healthcare professionals to further improve your essay. A well-written essay on birth control will not only demonstrate your understanding of the topic but also your ability to engage with complex health and social issues.

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Home — Essay Samples — Nursing & Health — Public Health Issues — Birth Control

Birth Control Essay Examples

Birth control essay topics and outline examples, essay title 1: birth control methods and their impact on reproductive health and family planning.

Thesis Statement: This essay explores various birth control methods, their effectiveness, and their impact on reproductive health and the ability to make informed family planning decisions.

• Introduction
• Overview of Birth Control Methods: Contraception Options and Their Mechanisms
• Effectiveness and Safety: Evaluating the Reliability and Risks of Different Methods
• Reproductive Health: Discussing the Positive and Negative Effects of Birth Control
• Family Planning: Examining the Role of Birth Control in Decision-Making
• Access and Education: Addressing Barriers and Promoting Awareness
• Conclusion: Empowering Individuals to Make Informed Choices

Essay Title 2: The Societal Impact of Birth Control: Shaping Gender Equality, Family Dynamics, and Healthcare Policies

Thesis Statement: This essay delves into the societal consequences of birth control, including its role in promoting gender equality, influencing family structures, and shaping healthcare policies.

• Gender Equality: Analyzing How Birth Control Empowers Women and Promotes Equal Opportunities
• Family Dynamics: Exploring Changes in Family Size, Planning, and Roles
• Healthcare Policies: Investigating the Accessibility and Regulation of Birth Control
• Ethical Considerations: Discussing Moral and Religious Perspectives
• Global Impact: Examining Birth Control in the Context of Population Control and Development
• Conclusion: Reflecting on Birth Control's Evolving Role in Society

Essay Title 3: Birth Control Education: Promoting Comprehensive Sexual Health Programs for Informed Choices and Safer Practices

Thesis Statement: This essay advocates for comprehensive sexual health education programs that equip individuals with knowledge about birth control options, safe practices, and informed decision-making.

• Sexual Health Education: The Importance of Providing Comprehensive and Accurate Information
• Birth Control Methods: Teaching About Options, Effectiveness, and Risks
• Safe Practices: Promoting Responsible and Consensual Sexual Behavior
• Addressing Myths and Misconceptions: Dispelling Common Misinformation
• Role of Schools and Parents: Collaborative Approaches to Sexual Health Education
• Conclusion: Fostering a Knowledgeable and Empowered Youth

The Importance of Birth Control in Preventing Unwanted Pregnancy

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Analysis of Margaret Sanger’s Speech on Birth Control

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Exploring The Association Between Oral Contraceptive Pills and Glaucoma

Comparative analysis of drug abuse potential, addressing women's rights in africa, examining the impact of donald trump's presidency on healthcare, and societal tensions, exploring the decline in church attendance among millennials, free birth control: public health and ethics, relevant topics.

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91 Birth control Essay Topic Ideas & Examples

🏆 best birth control topic ideas & essay examples, 📌 simple & easy birth control essay titles, 👍 good essay topics on birth control, ❓ research questions about birth control.

• Rhetoric: “The Morality of Birth Control” by Margaret Sanger In her speech, Sanger supports the argument that the American women should have the right to learn more about the birth control because of their responsibility for the personal health and happiness in contrast to […]
• Birth Control on the Level of Individual Woman It was not allowed up to the year 1938, that the court lifted the prohibition of birth control. In my opinion, all women should be allowed to have access to birth control methods.
• Population Increase and Birth Control The end of the 2oth century can be seen as a starting point to the global rivalry between nations, states and continents.
• Human Sexuality Birth Control They include tubal ligation that involves the cutting of the fallopian tube which supplies ova to the uterus for fertilization it can also be done on men through vasectomy which involves the cutting of the […]
• Birth Control, Pregnancy and Childbirth According to Priscilla Pardini who is a re-known scholar in this field of the study states that: “It is can be viewed as a selfish study in the way that an educational institution is studying […]
• Why Teenagers Must Be Allowed to Use Birth Control? It is the purpose of this paper to underscore why teenagers should be given the opportunity to use contraceptives. These findings point to the importance of contraceptives in solving the problem of teenage pregnancy in […]
• Abortions and Birth Control As a result the overall mortality of women increases in the countries where legal abortions take place. The general point of view in decreasing the number of abortions is the use of contraceptives as a […]
• Birth Control for Teenagers This is exactly the reason why the idea of using birth control should not be given to teenagers. The third reason why birth control should not be advocated for teenagers is that there are more […]
• The Birth Control: Safe Methods The first relates to a couple that uses the method correctly every time the couple has sexual intercourse and the latter is for an average couple who actually do not use the method every time […]
• Birth Control Education and Resource Availability for the Prevention of Teen Pregnancy The rationale for this position is mostly based on the fact that teen pregnancy tends to create more complex problems in the future pertaining to the education and literacy rate of the population, the increase […]
• Advanced Pharmacology: Birth Control for Smokers The rationale for IUD is the possibility to control birth without the partner’s participation and the necessity to visit a doctor just once for the device to be implanted.
• Birth Control Methods & Options The male condom is one of the most popular and arguably the least complex methods of contraception. This leads to the prevention of fertilization and interferes with the movement of sperm and effects.
• Birth Control Against Overpopulation Based on the information presented, it can be seen that the current growth of the human population is unsustainable in the long run due to the finite resources on the planet.
• Giving Birth Control to Teenagers It is paramount to say that it is a significant problem that needs to be addressed because the number of cases of teenage childbearing is one of the highest in the United States compared to […]
• Population Growth Control From a perspective of political economy, control of the population is a matter that is in the sphere of women, and thus they deserve to have right to their sexuality and reproduction.
• Doctors’ Reluctance to Prescribe Birth Control Pills to Early Adolescents These are some of the proposed solutions that could help solve the problem of doctors not prescribing birth control pills to teenagers.
• Why The Regulation Of Birth Control Should Be The Health
• Understanding Your Birth Control Options
• Unaware And Unprotected: Misconceptions Of Birth Control
• The Different Methods of Birth Control in Our Modern Society
• Should Tennagers Be Allowed to Get Birth Control Without Parent Consent?
• The Birth of Birth Control: An essay on Margaret Sanger
• The Consequences of Using Birth Control on the Spread of HIV/AIDS in the United States
• The Effect of Sanger’s Birth Control Movement
• Talking To Your Folks About Starting Birth Control
• Why Birth Control Should Be Readily Accessible To Teenagers
• What You Ought To Know About Emergency Birth Control
• The African American Community and the Birth Control Movement
• Which is the Best Birth Control Method: Pills, Patch, Nuvaring, or Depo Shot
• The Ethical Debate of Free Contraception and Birth Control
• Various Options of Birth Control and Their Effectiveness
• Should High Schools Provide Birth Control Information And Condoms
• To Control or to Not Control: The Government and Birth Control
• Why Parents Should Obtain Birth Control
• Social and Political effects of Birth Control in England
• Uncertain Aims and Tacit Negotiation: Birth Control Practices in Britain, 1925-50
• Taste Buds Outside The Mouth And Male Birth Control
• The Cognitive Response Theory On Birth Control
• The Birth Control Pill: The Pill That Changed America
• Teens Getting Birth Control Without Parental Consent
• The Perspective of Margaret Sanger on Birth Control
• The History of Birth Control and Society
• The Negative Effects of Birth Control for Minors without Parental Consent
• Undergrad: Birth Control and Human Sexuality
• Teenage Girls Should Be Allowed For Get Birth Control Without
• The Misconceptions Of Birth Control In Developing Countries
• Television As Birth Control By Fred Pearce
• Women Have the Burden of Birth Control
• The Problems With the Birth Control Options for the Modern Society’s Teens
• The Pitfalls And Positives Of Abstinence Only Birth Control
• The Question of Whether the Use of Birth Control Increases Promiscuous Sexual Behanvor
• The Lack of Significant Advances for Men’s Health and Male Birth Control
• The Positive And Negative Effects Of Birth Control Pills
• The Pros and Cons of Over the Counter Birth Control Pills
• The Introduction of Birth Control in Things Fall Apart, a Novel by Chinua Achebe
• The Importance Of Educating Adolescents On Various Birth Control Methods
• The Significance of the Introduction of Birth Control for Teens to Prevent Teenage Pregnancy
• The Supply of Birth Control Methods, Education, and Fertility: Evidence from Romania
• The Social Impact of Birth Control in Germany
• The Sexual Activity and Birth Control Use of American Teenagers
• Why Should Birth Control Be Taught in Schools?
• Should Governments Provide Free Access to Birth Control?
• Why Isn’t Birth Control Education Being Taught in Schools?
• How Does Birth Control Affect Society?
• Should Americans Have Easier Access to Contraception?
• Why Should Parents Obtain Birth Control?
• Should Public School Students Be Given Birth Control Pills?
• Does Parental Consent for Birth Control Affect Underage Pregnancy Rates?
• Why Should Women Not Use Birth Control?
• Should Schools Distribute Birth Control?
• How Does Banning Birth Control Affect Women’s Lives?
• Should Birth Control Pills Be Available for Teenage Girls?
• How Does the Birth Control Pill Work?
• Should Birth Control Pills Be Sold Over the Counter?
• How Has Abortion and Birth Control Affected the 20th and 21st Century?
• Should High Schools Provide Birth Control Information and Condoms?
• What Should Women Know About Birth Control Pill?
• Should Teenagers Have Access to Birth Control Without Parent’s Consent?
• Why May Birth Control Patches Be More Dangerous Than Pills?
• Should Teenagers Have Access to Birth Control?
• Why Should Birth Control Be Readily Accessible to Teenagers?
• Should Health Insurance Companies Provide Complete Coverage for Birth Control?
• Does Learning About Birth Control in School Help Prevent Teen Pregnancy?
• Should Pharmacists Be Allowed to Refuse to Fill Emergency Contraception Prescriptions?
• What Are Some of the Current Birth Control Options?
• How Are Federal Reproductive Health Rights Legislation or Denied by State and Local Government?
• What Myths About Health Risks Associated With Contraceptive Devices?
• Should Birth Control Be Taught in School as a Way of Preventing Teen Pregnancy?
• What Are Some of the Religious/Ethical Issues Arising From the Usage of Birth Control?
• What Are Factors to Consider When Choosing the Right Birth Control?
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• Open access
• Published: 09 February 2021

A qualitative exploration of contraceptive use and discontinuation among women with an unmet need for modern contraception in Kenya

• Susan Ontiri   ORCID: orcid.org/0000-0001-7622-5714 1 , 2 ,
• Lilian Mutea 3 ,
• Violet Naanyu 4 ,
• Mark Kabue 5 ,
• Regien Biesma 2 &
• Jelle Stekelenburg 2 , 6  

Reproductive Health volume  18 , Article number:  33 ( 2021 ) Cite this article

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Addressing the unmet need for modern contraception underpins the goal of all family planning and contraception programs. Contraceptive discontinuation among those in need of a method hinders the attainment of the fertility desires of women, which may result in unintended pregnancies. This paper presents experiences of contraceptive use, reasons for discontinuation, and future intentions to use modern contraceptives.

Qualitative data were collected in two rural counties in Kenya in 2019 from women with unmet need for contraception who were former modern contraceptive users. Additional data was collected from male partners of some of the women interviewed. In-depth interviews and focus group discussions explored previous experience with contraceptive use, reasons for discontinuation, and future intentionality to use. Following data collection, digitally recorded data were transcribed verbatim, translated, and coded using thematic analysis through an inductive approach.

Use of modern contraception to prevent pregnancy and plan for family size was a strong motivator for uptake of contraceptives. The contraceptive methods used were mainly sourced from public health facilities though adolescents got them from the private sector. Reasons for discontinued use included side effects, method failure, peer influence, gender-based violence due to covert use of contraceptives, and failure within the health system. Five reasons were provided for those not willing to use in the future: fear of side effects, cost of contraceptive services, family conflicts over the use of modern contraceptives, reduced need, and a shift to traditional methods.

This study expands the literature by examining reasons for contraceptive discontinuation and future intentionality to use among women in need of contraception. The results underscore the need for family planning interventions that incorporate quality of care in service provision to address contraceptive discontinuation. Engaging men and other social influencers in family planning programs and services will help garner support for contraception, rather than focusing exclusively on women. The results of this study can inform implementation of family planning programs in Kenya and beyond to ensure they address the concerns of former modern contraception users.

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Use of contraceptive methods allows spacing of pregnancies or limiting family size, enabling individuals and couples to fulfill their fertility desire by choosing if and when to become pregnant. Contraceptive use not only has positive effects on health-related outcomes, such as improved maternal and child health [ 1 ] but also improves schooling and economic outcomes for girls and women [ 2 ]. Global trends have shown an increase in contraceptive uptake, however, many women, approximately one out of three, discontinue their method within a year [ 3 , 4 ]. Contraceptive discontinuation is an important determinant of contraceptive prevalence, as well as unintended pregnancies, and other demographic impacts as it increases the unmet need for family planning (FP). Several studies have found that contraceptive abandonment and failure contribute substantially to the total fertility rate, unwanted pregnancies, and induced abortions [ 3 , 4 , 5 ]. Analysis of data from 36 developing countries revealed that over one-third of unintended pregnancies resulted from women who had discontinued the use of contraception [ 5 ]. Unintended pregnancies have negative consequences on the health and well-being of women and their families as they can lead to maternal morbidities and even death. Besides, it is documented that children born from unintended pregnancies are: less likely to be breastfed, more likely to be stunted, at risk of a lack of parental love, and at higher risk of child mortality than children from wanted pregnancies [ 6 ].

An analysis of Demographic and Health Surveys conducted by Curtis et al. demonstrated that women’s socio-demographic characteristics—age, education, place of residence, and economic status—are the determinants associated with contraceptive discontinuation [ 7 ]. Even though studies indicate that women with higher levels of education and those residing in urban residences are more likely to discontinue their initial method, additional analyses reveal that these women are more likely to switch than stop after discontinuing a method [ 7 , 8 , 9 ]. This could be because they are enlightened on their contraceptive choices and will discontinue and switch if a particular method does not suit them since they can also easily access the contraceptive services due to shorter distances to health facilities.

Researchers continue to investigate why a woman or a couple would discontinue the use of modern contraception while still in need. Past studies show side effects and health concerns have been the main causes of contraceptive discontinuation [ 3 , 4 , 10 ]. Indeed, side effects account for more than half of the reasons for discontinuing contraceptives while still in need [ 9 , 11 ].

Kenya has implemented a strong national family planning (FP) program since it was launched in 1967 [ 12 ]. Over the past five decades, the country has developed FP/reproductive health policies, strategies, and guidelines and implemented programs aimed at increasing access and utilization of modern contraceptive methods among women of reproductive age and supporting men's involvement. These efforts have borne fruit; the current data estimates a contraceptive prevalence rate of 62.8%, which is mostly driven by the use of modern methods at 60.7% [ 13 ]. However, more than one-third of all pregnancies in Kenya are unintended and one in three women discontinue use of contraceptives by 12 months [ 14 ]. Like other countries, the main reason cited in Kenya for discontinuation is side effects, predominantly side effects associated with hormonal contraception [ 14 ]. Studies have linked poor quality of care, particularly inadequate counseling on side effects with contraceptive discontinuation [ 4 , 15 ]. For instance, data from round 5 to round 7 of Kenya’s Performance Monitoring and Accountability 2020 surveys indicate a glaring gap in the quality of FP services provided in health facilities. Only two-thirds of women were informed about side effects by service providers, with slightly more than half being informed about what to do in case of side effects [ 13 , 16 , 17 ].

Whereas the predictors of contraceptive counseling have been established by several quantitative studies [ 3 , 4 , 18 ], there is a paucity of information to understand the lived-in experiences of women who discontinue the use of contraceptives while still in need. This paper reports qualitative results from in-depth interviews and focus group discussions with discontinuers. The interviews and discussions explored experiences with previous use of modern contraceptives, reasons for discontinuation, and future intention to use contraceptives among discontinuers.

Study design and setting

A cross-sectional qualitative study was conducted as part of a formative assessment in a 24-month longitudinal study on evaluating the dynamics of contraceptive use, discontinuation, and switching in Kenya. The longitudinal study is being conducted in Kitui and Migori, rural counties in Kenya. The two counties have a diverse method mix; Migori’s mCPR is mostly driven by long-acting reversible contraceptives, at 72% while in Kitui, short-term methods are more popular, at 64% [ 14 ]. Details of the longitudinal study, including the study setting, have been published elsewhere [ 19 ]. Ten public health facilities, five in each county were purposively selected based on high FP caseload. The 10 facilities were located in 10 different sub-counties. Routine service statistics revealed that these facilities provided the highest number of contraceptive services in their respective sub-counties. Out of the ten facilities, 2 were county hospitals, 5 sub-county hospitals, 2 health centers, and 1 dispensary. The consolidated criteria for reporting qualitative research (COREQ) was used in this paper [ 20 ]. The completed checklist is available in Additional file 1 .

Study participants

Since the main objective of this study was to explore the experience with contraceptive use and discontinuation among discontinuers, participants who met the following inclusion criteria were selected: women of reproductive age between 15 and 49 years of age, who were sexually active, did not desire pregnancy, and had been but were currently not using modern contraception. The men who were interviewed to explore their perspective on contraceptive discontinuation were purposively selected since they were spouses of the women who met the inclusion criteria. Data collection included FGDs with adolescent mothers aged 15–19 years and women over 20 years and IDIs with couples and adolescent girls. Recruitment of study participants stopped once data saturation was achieved, that is when no new information was derived from the interviews and focus group discussions. In total, 42 data collection sessions (12 FGDs and 30 IDIs) were conducted with 135 study participants-105 in FGDs and 30 in IDIs. (Table 1 ).

Recruitment strategy

The study team selected community health volunteers (CHVs) who were providing health information including family planning to households within the catchment area of the study facilities. The CHVs were trained on the inclusion criteria and thereafter, mobilized and screened community members within their catchment area before referring them to the study staff who contacted, further screened, and recruited those eligible into the study. For couples, the CHV would approach the woman first to establish eligibility, before contacting the spouse. Both partners had to agree to participate before inclusion in the study.

Data collection

Data collection was conducted from May to July 2019. The data collection team was comprised of 10 research assistants, (seven females and three males) who had undergraduate training in Anthropology or Sociology. The team was selected based on their experience conducting qualitative studies. They further received an additional 5-day refresher training before data collection. They worked under the supervision of the lead author. Respondents were not known to the interviewers before the data collection sessions. Written consent was obtained from the participants to conduct and audio-record the data collection sessions. The time and place of the interviews were determined based on the convenience of the participants. The venue for the FGD data collection sessions was community halls while the IDIs were conducted at the participants’ homes. All participants were aware that the study was being conducted to explore their perspective and experience with contraceptive use and discontinuation as part of a formative assessment to improve the quality of family planning services provided.

Semi-structured topic guides covering FP topics for the various audiences were developed and piloted before use. The FGD guide included open-ended prompts related to knowledge and perception of contraceptives, use of FP with their community, and reasons for contraceptive discontinuation, including influencers. The study had IDI guides for the adolescent girls (15–19 years) and for married couples (18–49 years), husbands and wives were interviewed separately. The former group was asked about their knowledge and perceptions around sexual and reproductive health and contraceptive use, experience using contraceptives, and contraceptive discontinuation. The married couples shared their knowledge, perception, and decision-making experiences using contraceptives; FP use and discontinuation; and couple involvement in contraceptive use and discontinuation. The file showing the topic guides used in this study is provided in Additional file 2 .

Two trained interviewers were present at each FGD—one as a session moderator and the other as a note-taker. For the IDIs, only one trained moderator was present for the conversation. No observer was present during data collection. The FGDs and interviews were conducted in local dialect (Kamba and Dholuo) and Swahili. All the interviews were audio-recorded, and field notes were taken for each focus group session. The interview sessions lasted between 30 and 90 min. The data collection team debriefed after the end of each session. Interim findings were discussed weekly by the team and interview guides were modified and revised as needed. At the end of data collection, no new themes were emerging and data saturation had been achieved.

Data analysis

The digital recordings of IDIs and FGDs were transcribed verbatim, translated into English, and analyzed using NVivo 11. Data were analyzed thematically following the approach of Braun and Clarke to identify, analyze, and report patterns within the data [ 21 ]. Coding and theme development were directed by the content of the data (inductively) [ 21 ]. A final agreed thematic framework was applied to all interviews. Transcripts were not returned to participants in advance of coding. Data analyses were performed by two researchers (VN and SO) with in-depth knowledge of qualitative analysis who were supported by two analysts to ensure timely coding and validation of the coding frame. The team identified themes from reading and rereading the transcripts, noting any similarities and differences between and within participants’ accounts. The preliminary findings were shared with some of the study participants for validation.

Ethical considerations

This study was guided by a protocol that was approved by the Kenya Medical Research Institute Institutional Review Board and the Johns Hopkins Bloomberg School of Public Health Institutional Review Board. Participants gave informed written consent/assent to participate in the study. Protection and confidentiality of participants was ensured through conducting data collection sessions in private settings, maintaining confidentiality, and limiting access to study information to only authorized personnel.

The demographic characteristics of the 135 study participants are shown in Table 2 . The majority of the participants were adolescents and youth aged 15–24 years at 51%, had primary education 53%, were farmers 32%, and had one to two children (Table 2 ). The findings from the two study sites were comparable, with no major differences.

Study findings are provided in four themes below: (1) motivation for modern contraceptive use; (2) sources and decision-making for previous contraceptive used; (3) barriers to sustained use of contraceptives; and (4) future intention to use contraceptives.

Motivation for modern contraceptive use

The study explored the participant’s motivation for use of a contraceptive prior to discontinuation. Generally, there was strong consensus among all the study participants that the reasons for using contraceptives were to plan for the number of children they wished to have, and prevent pregnancy. Adolescent participants further noted that the greatest motivation for using contraceptives was to prevent pregnancy so as to pursue studies; they wanted to avoid unplanned pregnancies that might result in having to drop out of school and take on parental responsibilities they had not envisioned.

Economic reasons appeared to be the major impetus for use of contraceptives by adolescent mothers, older women, and married couples, as most participants shared similar sentiments on the need to have children they can manage to raise as illustrated by the following quote:

“We are able to space out the children and able to provide the right foods to the children so that they can be healthy because our incomes are low.” (FGD, Female).

Many participants reported that their motivation for use of contraceptives was to space their pregnancies to allow the healthy growth of children so they could get enough attention, nutrition, and care from their parents. A few married women noted, where couples were experiencing marital conflict, women used contraceptives to avoid getting additional children that they would need to support on their own.

Sources and decision-making for previous contraceptive used

The majority of participants interviewed indicated that they got their contraceptive method from public health facilities. Some, especially adolescents, got their contraceptive methods from private facilities, specifically chemists or pharmacists. Most older respondents indicated that they had opted for injectables and implants, while use of pills was mainly mentioned by adolescents.

“I bought my pills from the pharmacy shop in town” (IDI, Adolescent, Female).

The study findings revealed that before using contraception, most women sought the opinions of partners, peers, or family friends. For adolescent mothers, their mothers were mentioned as helpful in decision-making and accessing contraceptives. Most partners were involved in decision-making about uptake of FP before initiation of a method, while some were engaged after the FP method was started. However, some female participants stated that they had used contraception covertly due to non-supportive spouses or relatives, particularly the in-laws who threatened to report them to their partners.

Barriers to sustained use of contraception

The study further explored the reasons why women did not continue using a contraceptive method yet they still had a need for contraception. Reasons for discontinued use of contraceptives were manifold; five main sub-themes emerged: side effects, method efficacy, peer influence, gender-based violence, and health system factors.

Side effects of contraceptives

Across all the study groups, side effects resulting from use of contraception were repeatedly mentioned among the reasons for discontinuation. The leading side effect was irregular bleeding patterns presenting as menorrhagia (heavy menstrual bleeding) or amenorrhea (absence of menstrual bleeding). This was mainly experienced from the use of hormonal methods, and in particular injectables and implants. For example:

“When I used the three-months injection, I was bleeding excessively. Sometimes I would feel dizzy while walking. The bleeding would even continue for a month without stopping. So, I decided to stop using it.” (IDI, Female).

Heavy bleeding was cited to interfere with the participants’ social and economic lifestyle. The majority of the female participants who reported increased bleeding indicated that they were unable to carry out their economic activities since they were weak as a result of the increased menstrual flow. Another recurrent consequence of the increased bleeding was the interference with their sexual life:

“The reason I chose to stop using depo is for one reason. Sometimes my husband may have the desire to get intimate with you but you cannot, because of the bleeding. Whenever I want us to get intimate he declines because it is so much blood that is why he told me to try quitting it.” (IDI, Female).

On the contrary, some respondents reported that the absence of menstrual bleeding was what triggered discontinuation since they did not know whether they were still fertile or were pregnant.

“When I started using implants, my periods did not come for eight months, then it came back only for two days and disappeared again. I decided to stop using a contraceptive since I was always wondering whether I was pregnant.” (FGD, Adolescent).

Other side effects that led to discontinuation, albeit less frequently mentioned across the various study groups, included weight changes, dizziness, and low sexual libido.

“ My friend who was using the one for three years told me she stopped because she didn’t have an appetite for having sex, so it was raising issues between her and her husband.” (FGD, Adolescent).

Some study participants observed that experiences from other women influenced contraceptive use or discontinuation. Several FGD participants indicated that women discontinued the use of contraceptive methods after learning about side effects experienced by their friends. This prompted even those who were not experiencing the same to discontinue out of fear.

Contraceptive method efficacy

Contraceptive efficacy was a concern mentioned mostly by married couples. Respondents reported method failure whereby women got pregnant unexpectedly while still on a contraceptive method:

“One year after using an implant, I started becoming sick. When I went back to the hospital, I was tested and the results came out that I was four months pregnant, and at the same time I still had the implant in my arm.” (FGD, Female).

“I have a friend; she was using the one for 3 months. After sometime, she was shocked that she was pregnant. So, she decided that she will not use it because even if you use it you still get pregnant.” (FGD, Adolescent).

Several participants revealed that they decided to discontinue use of contraceptives after learning about cases of method failure among women who were using similar methods. On several instances, inconsistent use of contraceptive, especially short-term methods, that resulted in pregnancies were reported as method failure by some participants:

“The one for three months confused her a lot, it came to end without her knowing and she forgot to go back to the clinic for another injection. She became pregnant and then it surprised her. We had tried using it for a long time and I told her that she was using a method of a shorter duration and when it ended she became pregnant without planning.” (IDI, Male).

Covert use of contraception resulting in gender-based violence

Covert use of contraception was common due to lack of spousal support for use of a modern method. Across all the study groups, the participants shared their experiences or cases of other women who discontinued contraceptive use because their partners learned that they were using it covertly. Cases of gender-based violence directed at women by their partner after learning their use of modern contraceptive methods, further solidified their resolve to discontinue as illustrated by this experience:

“Another woman in our village went and got an implant without her husband’s knowledge. When the husband learned of this, he took a knife and removed it from her arm. This made my friends and me afraid, so we decided to just remove it for fear of what our husbands would do if they find out.” (FGD, Female).

Health system factors as a barrier to continuation

Health care system factors were repeatedly mentioned as reasons for discontinuation. Stock-outs of preferred methods during contraceptive initiation or resupply prompted women to either take alternative methods or leave without one. Provider bias that resulted in women taking up methods that they did not approve of came up as a sub-theme particularly by younger women, as shown in the quote below:

“I told him [the provider] I wanted depo and he said that the government does not advise the use of injection, and he refused to put it on me. He convinced me to take up an implant, which I did, but I went to another facility to have it removed.” (FGD, Female).

There were mixed experiences regarding FP counseling, particularly on side effects. Several respondents noted that they got adequate counseling by the health care providers during the initiation of a method; however, some mentioned that they were not informed of any potential side effects that could result from use of contraception.

“When I started using them, the doctor explained to me about the advantages and disadvantages of the various methods of family planning, such that, I know the goodness and effects of the method I am using.” (FGD, Female).

Future intentionality to use contraception

The study explored whether the respondents would consider using modern contraceptives again. Several respondents indicated willingness to use at some time, but some were hesitant. Those who would consider using an FP method again said they would consult widely, select a method with fewer side effects, and one with a longer duration. For those who were doubtful and not considering using FP, five reasons were provided.

First, there were fears about negative side effects. Women indicated that the fear of experiencing another side effect after discontinuation led them to decide not to take up any other modern method despite the counseling that they got from health care workers who were advising them on method switching. One woman shared her experience:

“These medicines bring problems. I stayed with the one injection for a while and every time I would feel sickly, weak, back pains at all times, bleeding from Monday to Monday. I came to the hospital and asked them to remove it. They asked me what the problem was, that they will give me another one, but I did not want one. So that is why I stopped using.” (FGD, Female).

Second, cost was cited as a barrier for continued use. Respondents indicated that the direct and indirect costs associated with uptake of contraceptive services hindered their intention to use. The cost barrier was mainly mentioned for short-term methods that require frequent resupply at facilities, hence, women had to make multiple visits to the facility. Several concerns were also raised regarding the removal of intrauterine contraceptive devices or implants after experiencing side effects. An important issue that participants highlighted was the cost incurred for the removal of a method, which caused women to fear the selection of another method in case they experienced side effects with that method.

“If you go to the facility before the expiry date, you are asked to pay 200 shillings, regardless of the side effects experienced. I wonder why they charge for removal yet they gave it for free. After that one fears to take up another method.” (FGD, Female).

Lastly, FP use caused conflicts in families. Women indicated lack of support from their partners and relatives impeded their intention to use contraception. It was evident that even though the women felt a need to space or limit their family size, that decision was mainly made by their partners. Other women, who had previously used the method covertly and had been discovered by their spouses or relatives, mentioned they could not use the method for fear of gender-based violence. This quote buttresses the point:

“My husband threatened to beat me also if he ever found me using a method. This was after he had observed a disagreement between our neighbors (couple), over the discreet use of contraceptives that ended up with the lady being hit by her husband. I decided to stop using to avoid such an occurrence. ” (IDI, Female).

This qualitative study aimed to explore the dynamics of contraceptive use and discontinuation among women with unmet need for contraceptives in the rural counties of Migori and Kitui, Kenya. A large and diverse group of adolescents, women, and couples who reported contraceptive discontinuation while still in need of a method provided insights on their experiences, perspectives with contraceptive use and reasons for discontinuation. Direct quotes of study participants about their experiences with FP use that culminated in discontinuation have been presented to deepen understanding of participants’ experiences [ 22 ]. From the study findings, it is evident that all the respondents chose to use contraceptives with the conviction that by using a modern method, they would be able to prevent pregnancy or plan when to have children, determine how far apart they want their children to be, and when to stop having children. However, this desire was not fully realized as they discontinued use of the contraceptives while still in need, which added to the pool of women of reproductive age with unmet need for FP.

There were numerous challenges faced by women using contraceptives that prompted them to discontinue their use. As noted in prior studies, side effects play a major role in reported decisions to discontinue [ 4 , 23 , 24 ]. Our study revealed that the most common side effect leading to contraceptive discontinuation were changes in users’ bleeding patterns, findings which are consistent with studies conducted across different parts of the world [ 18 , 25 , 26 ]. Irregularity of bleeding negatively impacts the well-being of women, mainly due to the social consequences, which could explain the low tolerance with contraception when such side effects are encountered. Studies have revealed that women, especially in the sub-Saharan region, believe that menstrual bleeding is a sign of fertility, hence any change that leads to reduced or no bleeding is frowned upon [ 27 , 28 ]. Conversely, increased bleeding impacts women’s socio-economic activities and sexual relationship with their partners [ 28 , 29 ].

Our findings thus provide strong support for addressing side effects experienced by women through management when they occur or being provided options for method switching to ensure the women continue to harness the full benefits of contraception. This can be achieved by conducting client follow-up by service providers to periodically assess the level of satisfaction with the contraceptive method while addressing issues that might prompt clients to discontinue. Proper counseling of clients, and their partners, is crucial to promote continuation with use of modern contraceptive methods as the users are made aware of the contraceptive’s mechanism of action, possible side effects, and what to do when they experience side effects. Helping women understand typical bleeding changes associated with their contraceptive methods could lead to greater acceptance of the changes, increased method uptake, improved satisfaction, and higher continuation rates [ 30 ]. Therefore, capacity building of health care providers on contraceptives should not just focus on the technical skills on insertion and removal (particularly for long-term methods), but also on contraceptives’ mechanisms, how they work, to ensure that providers are well versed on the potential side effects for each method. This is supported by evidence from studies in Madagascar and Ghana that revealed providers were not well informed on the physiological effects of contraception and how to manage side effects [ 4 ]. This resulted in inadequate counseling of women experiencing the side effects; women were counseled to switch to another method instead of being reassured that side effects would settle down over time or being offered medication to control some side effects [ 4 ]. This could be attributed to inadequate training content on side effects. A recent review of FP counseling, training, and reference materials revealed that bleeding changes are insufficiently addressed in capacity building resources and counseling tools for health care providers [ 29 ]. This is alarming, considering that the leading reason for discontinuation has been changes in bleeding pattern. Skilled counseling for side effects, particularly bleeding irregularities, can only be achieved if training materials for health care providers incorporate this information, information that will improve the quality of counseling by health care providers.

Contraceptive method failure was one of the reasons for discontinuation in this study. Method failure is a factor of either failure of a method to work as expected or incorrect/inconsistent use of a method by the user. In low- and middle-income countries, 74 million unintended pregnancies occur annually, of which a sizable share, 30%, are due to contraceptive failure among women using some type of contraceptive method [ 31 ]. Each contraceptive method has a Pearl Index number that reflects pregnancy rates during perfect and typical use, with use of long-term method conferring higher efficacy than short-term methods [ 32 ]. Whereas all contraceptive methods have some degree of failure, even during perfect use, failure rates can be reduced when individuals are sensitized on the proper use of contraception to ensure the method is used correctly and consistently. Provision of clear information about the risks and benefits of all available methods is crucial in facilitating informed contraceptive choice so women can make an educated choice for their preferred methods, which may reduce discontinuation.

Other reasons for contraceptive discontinuation, such as lack of support from partners and other social networks, are also corroborated in researches previously conducted in Kenya [ 28 , 33 ]. In our study, the decision to use or not use contraceptives was still primarily made by men. Although women made solo decisions on FP, they were heavily influenced by their spouses’ preference and would stop using if they thought it would bring marital conflicts. Opposition to contraceptive use by husbands appears to stem from the fear of side effects and the perception that women who use FP are more likely to be promiscuous. Additionally, Kenya being a highly patriarchal society, decision-making around the desired number of children mainly lies with the male partner. FP programs have mainly targeted women with information to promote uptake since they are the ones who face the risk of pregnancy and childbirth. Unfortunately, these programs have left out men, who are in most instances, the decision-makers in male-dominated societies, like most countries in the sub-Saharan region [ 34 ]. The findings from this study reveal the power dynamics when it comes to a couple’s decision to use contraception. This underscores the need to meaningfully involve men in FP programs by informing them of the health, economic, and social benefits realized from proper and consistent use of contraception so they can optimize use of FP services. Demand generation strategies that employ the use of positive deviants, satisfied users, and other key influencers, such as mothers-in-law, may lead to an increase in contraceptive uptake and enhance continuation.

This study indicates that the costs associated with consistent use of FP methods hinder their continued use. Promoting uptake of LARC methods will address the cost associated with the use of short-term method—LARCs have been shown to be more cost-effective and do not require frequent visits to facilities [ 35 ].

Our study also revealed punitive measures women faced, especially those on LARCs, when they wanted to switch to another method before its expiration. Allowing for method switching is indicative of strong FP programs that have an adequate range of methods and a flexible environment to meet women’s needs. Due to the health and social concerns that contraceptive use may confer on individuals, women may try different methods before settling for their preferred option. The health system should have a supportive policy environment that accommodates such needs of women by: instituting guidelines that prohibit penalization for method switching; addressing commodity stock-outs and ensuring sufficient method mix through increased financing of FP programs; and sensitizing providers on the importance of method switching by women who are not satisfied with their methods. Additional studies are needed to document the implications of frequent method switching on commodity security in countries that continue to face widespread stock-outs of contraceptive methods.

The study’s main strength was documenting the experiences of contraceptive use and discontinuation among discontinuers themselves. However, qualitative studies have limitations related to validity, subjectivity, and reliability. To address these issues, efforts were made to increase the rigor and trustworthiness of the findings through the selection of participants with a range of backgrounds and experiences with the guidance and supervision of experts, as well as external review. Information was not collected on the number of eligible participants who refused to participate in the study. Despite this, our study benefits from including a large number of participants, diverse in terms of age, gender, ethnicity, and location, and utilizing different data collection methodologies (FGDs and IDIs) to enrich the findings.

Conclusions

Our study, conducted in two rural counties in Kenya, revealed a number of important findings regarding factors influencing contraceptive use and discontinuation. The participants in this study had a common motivation for using contraception, to avoid pregnancies, however, side effects were a major hindrance in continued use of contraception. Covert use of contraception resulted in discontinuation when it was discovered and, in some instances, led to gender-based violence. Decision-making on contraception, method to use, and the number of children to have, was jointly done by couples or made by the husband. Reasons for discontinuation, specifically on side effects, were influenced by the husbands.

As contraceptive use in a population increases, success in avoiding unintended pregnancies depends less on initial contraceptive uptake and more on effective and persistent use. Enhanced efforts are needed to design and implement programs that focus on contraceptive discontinuation among women with unmet need for FP. Health care providers offering FP services should be well versed with the mechanism of action for the various contraceptive methods, and incorporate quality of care in the provision of contraceptive services. Additionally, contraception technological advancement is urgently needed to expand the method mix and to develop methods that have fewer side effects and side effects that can be more easily tolerated. This will go a long way in promoting continuation of contraceptive use, as indicated by a majority of our study participants who were willing to consider future use of contraception methods with fewer side effects. Findings from this study, as well as other studies, confirm the importance of engaging men and other social influencers in FP programs by educating them on the socio-economic and health benefits of family planning and dispelling any myths and misconceptions to create a social environment that supports use of modern contraception.

Availability of data and materials

The data used and analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Consolidated criteria for reporting qualitative studies

Community health volunteers

Focus group discussions

Family planning

In-depth interviews

Long-acting and reversible contraceptive

Total fertility rate

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Acknowledgements

The authors would like to acknowledge the generous contribution of time and expertise by those who participated in this study. We are grateful to Dr. Solomon Orero and Elizabeth Thompson from Jhpiego for reviewing the manuscript.

The study is funded by USAID Kenya and East Africa under Afya Halisi project, award number AID-615-A-17-00004. The funding institution did not play a role in the study design, implementation, in the writing of the manuscript, or in the decision to submit the article for publication.

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SO, LM, MK, RB and JS contributed to the design of the study. VN and SO performed data analysis. SO drafted the manuscript. All authors critically revised the manuscript and approved the final version. All authors read and approved the final manuscript.

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Ontiri, S., Mutea, L., Naanyu, V. et al. A qualitative exploration of contraceptive use and discontinuation among women with an unmet need for modern contraception in Kenya. Reprod Health 18 , 33 (2021). https://doi.org/10.1186/s12978-021-01094-y

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National Research Council (US) Committee on Population; Parnell AM, editor. Contraceptive Use and Controlled Fertility: Health Issues for Women and Children Background Papers. Washington (DC): National Academies Press (US); 1989.

Contraceptive Use and Controlled Fertility: Health Issues for Women and Children Background Papers.

• Hardcopy Version at National Academies Press

Health Effects of Contraception

Nancy C. Lee, Herbert B. Peterson, and Susan Y. Chu

• Introduction

Until the 1960s rhythm and barrier contraceptives were the only methods of birth control widely available to couples desiring to plan the number and spacing of their children. In the 1960s oral contraceptives (OCs) were introduced and new efficacious intrauterine devices (IUDs) became widely available, so that the choice of effective methods of contraception increased substantially. Later, in the 1970s, female and male sterilization techniques became much more widely accepted and used. Couples were then able to choose from several different temporary and permanent methods of contraception and to switch from one to another. Worldwide, family planning programs expanded, and the prevalence of contraceptive use increased.

As these methods of contraception became more widely used, anecdotal reports of adverse health effects associated with their use began to appear. Since the late 1960s and early 1970s, epidemiologic studies have more rigorously evaluated the health effects associated with the use of different contraceptive methods. Most of these studies have been conducted in the United States and Europe. In the process researchers have recognized that different contraceptive methods have important beneficial health effects, in addition to the desired effect of preventing pregnancy. Although much research is still needed, especially targeted to the developing world, a large body of information is now available to assess the health effects of the various contraceptive methods.

The various contraceptive methods have health risks, but pregnancy itself has attendant risks of morbidity and mortality. In 1983, Ory et al. attempted to quantify the mortality risks associated with using the various methods of contraception. Those risks were compared with the risks associated with using no method of contraception, which are actually the mortality risk associated with pregnancy. These estimates are presented in Table 1 . Using no method of contraception carries a higher cumulative risk of death than using any contraceptive method except that of OCs by older women who smoke. The mortality risks associated with using no contraception and with using OCs are higher in older women than in younger women. For all other contraceptive methods, the mortality risk does not appear to vary by age. Although the estimates are not presented in Table 1 , vasectomy involves no mortality risk for women and virtually none for the male partner (Ory et al., 1983).

Estimated Cumulative Number of Deaths per 100,000 Nonsterile Women Aged 17–44, Attributable to Contraceptive Method, by Age Group.

Below we will present in detail the health effects of the various widely available methods of contraception, limiting our discussion to those methods that are considered moderately to highly effective. Most epidemiologic and clinical studies of the health effects of contraceptives have been carried out in developed countries. We recognize the difficulty in generalizing these results to the special health and cultural situations in the less developed countries. Furthermore, the effects of the various contraceptive methods on the risk of diseases generally limited to less developed countries have had very little characterization. Because of the expanding role of family planning programs and contraceptive use in these countries, studies to evaluate the health effects of contraceptives in various regions and cultures are needed.

Modern contraceptive methods vary substantially in how effectively they prevent pregnancies. Because pregnancy itself has attendant health risks and benefits, the rates of accidental pregnancy associated with the various methods of contraception are one important aspect to consider when measuring the health effects of these methods. In 1987 Trussell and Kost published their comprehensive review assessing failure rates for each method of contraception. After reviewing all available studies, they estimated the rate of failure (i.e., accidental pregnancy) in the first year of use associated with ''perfect'' use of each contraceptive. They called this estimate the "lowest expected" failure rate; this rate should reflect the frequency of failures caused by the contraceptive itself. They also reported for each method a "typical" failure rate, defined as the rate of accidental pregnancy in the first year of use among typical couples who use that method. The typical failure rate is determined both by failures as a result of imperfect use of a contraceptive and by failures directly related to the method itself. Most of the typical failure rates were derived from national surveys of U.S. women. The authors summarized these rates, by contraceptive method, in a single table (Trussell and Kost, 1987, p. 271). We present a modified version of that table here ( Table 2 ). In our table and throughout the text we have substituted the term method failure rate for lowest expected failure rate and user failure rate for typical failure rate to follow more closely the terminology used in much of the existing literature. Note that the method failure rates are consistently low for most modern contraceptives. However, user failure rates vary widely, a function of the degree of acceptability and compliance required for successful use of each method.

Method Failure and User Failure Rates During the First Year of Use of a Contraceptive Method, United States.

• Oral Contraceptives

OCs, a highly effective method of birth control, are available in two types. Combination OCs, the most widely used, consist of both an estrogen and a progestin component. Most combination OCs contain a fixed daily dose of an estrogen and progestin and are taken for 21 of 28 days of each menstrual cycle (Hatcher et al., 1988). Recently introduced, phasic combination OCs contain varying doses of the estrogen and progestin components throughout the menstrual cycle. The second type of OC is the progestin-only pill (often called the minipill), which contains only a progestin. Combination OCs with fixed doses of estrogen and progestin have been used much more frequently than phasic or progestin-only pills; hence, most epidemiologic studies on the health effects of OCs are essentially studies of the effects of this type of OC.

OCs prevent pregnancy chiefly by inhibiting ovulation in almost all menstrual cycles, although OC-related changes in the cervical mucus and endometrium may also have contraceptive effects. Failure rates associated with OC use are low. The method failure rate for combination OCs is 0. 1 percent per year and for progestin-only OCs is 0.5 percent per year ( Table 2 ). The user failure rate cannot be readily determined for the two types of OCs separately, but it is about 3 percent per year for any type of OC. Because this user failure rate was derived from data where the vast majority of women used combination OCs, the figure probably is closest to the user failure rate for combination OCs. Most experts believe that the progestin-only pill has a higher user failure rate.

The health risks and benefits of OC use have been extensively studied and documented (Ory, 1982; Ory et al., 1983; Stadel, 1986; Prentice and Thomas, 1987). For a recent extensive review and list of references, see Stadel (1986) or Prentice and Thomas (1987).

Because OCs are highly effective at preventing any pregnancy, they appear to decrease greatly the risk of ectopic pregnancy. Results from a large case-control study of ectopic pregnancies conducted in the United States showed that current OC users had a relative risk of ectopic pregnancy of 0.1 (95 percent confidence interval, 0.1–0.2) compared with women who were using no contraceptive method (Ory, 1981).

Noncontraceptive Benefits

An important benefit from OC use is a reduction in risk of two serious reproductive system cancers, endometrial and ovarian cancers. This reduction has been documented in at least 9 and 11 epidemiologic studies, respectively (The Cancer and Steroid Hormone Study [CASH], 1987a, 1987b). Although the theoretical mechanisms that may explain these protective effects are quite different for the two types of cancer, the magnitude and characteristics of the protective effects are similar. The most detailed characterization of these protective effects comes from the CASH Study, a large case-control study conducted in the United States by the Centers for Disease Control, with support from the National Institute of Child Health and Human Development (CASH, 1987a, 1987b). OC use was associated with a 40 percent reduction in the risk of endometrial cancer as well as a 40 percent reduction in the risk of ovarian cancer, regardless of the specific formulation of combination OC used. The effect appeared to persist long after OC use had been discontinued; furthermore, protection increased with increasing cumulative duration of OC use.

The protective effect of OCs on endometrial cancer is most likely related to direct effects on the endometrium. Among current OC users the carcinogenic effect of unopposed estrogen on the endometrium is probably reduced because combination OCs contain both estrogen and progestin. The continued protection seen among past OC users is less well understood. Perhaps the combination of estrogen and progestin irreversibly changes endometrial cells so that they are not susceptible to carcinogens or to malignant transformation (CASH, 1987a).

Suppression of ovulation and suppression of pituitary secretion of gonadotropins have both been postulated as mechanisms by which OCs protect against ovarian cancer (Weiss, 1982). Two other factors that provide protection from ovarian cancer, increasing parity and breastfeeding (Gwinn et al., submitted), may also derive their protective effects from one of these two proposed mechanisms. Available epidemiologic studies do not provide sufficient information to choose one of these postulated mechanisms over the other.

Fourteen epidemiologic studies have found a decreased risk of benign breast disease (BBD) associated with OC use, including both case-control and cohort studies (Stadel, 1986). Evidence suggests that OCs decrease the risk of fibrocystic disease and fibroadenoma diagnosed by biopsy as well as the risk of breast lumps observed clinically but not biopsied. Results from a large cohort study conducted in the United Kingdom by the Oxford Family Planning Association have provided especially useful information about the relationship between OC use and BBD (Brinton et al., 1981). The decreased risk of BBD seen among women who use OCs occurs primarily among current or recent users who have used them for 2 years or longer. The relative risk among women who have used OCs for more than 2 years compared with nonusers is about 0.6 for fibrocystic disease and about 0.5 for unbiopsied breast lumps. The relative risk of fibroadenoma among women who have used OCs for less than 2 years is about 0.4, which is essentially the same as the relative risk of 0.3 among women who have used OCs for 2 or more years. The decreased risk of BBD does not persist among past OC users who have not used OCs for more than 1 year.

Many epidemiologic studies have found that a history of BBD increases a woman's risk of breast cancer. Even though OCs decrease the risk of BBD, epidemiologic studies have not found that OCs decrease the risk of breast cancer, as might be suggested by the OCs-BBD relationship. The most likely explanation for this paradox is that OCs probably decrease the risk of the large proportion of BBD that is not closely linked to breast cancer risk but do not decrease the risk of the types of BBD that increase a woman's risk of breast cancer (Stadel, 1986). Clearly, more information about the interrelationship between OC use, histologic types of BBD, and breast cancer is needed.

Seven epidemiologic studies have found that current or recent OC use reduces the risk of pelvic inflammatory disease (PID) (Stadel, 1986). On average, these studies have found that the risk of PID among OC users is about 40 percent lower than the risk among women using no contraceptive method.

The most detailed analysis of this issue comes from the U.S.-based Women's Health Study, a large hospital-based case-control study conducted from 1976 to 1978 (Rubin et al., 1982). This study found that the overall relative risk of PID among current OC users was about 0.5 compared with women using no contraception. However, this protective effect was limited to women who had been using OCs for at least 1 year. Furthermore, women not currently using OCs but who had used them in the past were no longer protected.

Two mechanisms have been proposed to explain how OCs protect against the development of PID. First, OCs may change cervical mucus so that it prevents pathogenic organisms from ascending into the upper genital tract. Second, because OCs reduce menstrual blood flow, a decreased amount of medium may be available for bacterial growth (Rubin et al., 1982).

Most of the studies of the relationship between OCs and PID have been hospital-based studies, so that case groups in these studies consisted of women hospitalized for PID. Because many women diagnosed with acute PID are not hospitalized, findings about women who are may not be generally extended to women who develop asymptomatic PID or symptomatic PID that does not require hospitalization (Washington et al., 1985). Specifically, gonorrhea may be an important cause of PID that requires hospitalization, whereas other bacterial etiologies such as chlamydia may cause much of the PID among women who do not require hospitalization. If OCs only protect against the bacterial etiologies of PID that are likely to require hospitalization, using OCs may not protect against some important causes of PID. Little epidemiologic evidence exists to clarify this question.

Results from a large cohort study in the United Kingdom have provided clear evidence that OC use decreases the risk of iron-deficiency anemia, in both current and past OC users (Royal College of General Practitioners, [RCGP], 1970). The protective effect provided by current OC use is probably due to the decrease in menstrual blood flow routinely seen among OC users. An increase in iron reserves probably accounts for the persistence of the decreased risk in past users. In countries where the prevalance of iron-deficiency anemia is high, this benefit to OC users may be especially important (Stadel, 1986).

Three epidemiologic studies have found that OC use decreases the risk of functional ovarian cysts, including follicular, granulosa lutein, and theca lutein cysts (Stadel, 1986). Decrease in risk appears to be confined to current OC users and is probably related to the suppression of ovulation that occurs during OC use.

Evidence from a case-control study that used data collected from the Oxford Family Planning Association cohort study suggests that OC use protects a woman from developing uterine fibroids (Ross et al., 1986). The risk of fibroids decreased with increasing duration of OC use: each 5 years of OC use contributed another 17 percent reduction in fibroid risk. The mechanism of the protective effect is still speculative. The authors proposed that circulating estrogens, either exogenous or endogenous, may promote the formation of fibroids and that the decreased risk associated with OC use may be explained by the modifying effect of the progestins in OCs.

Adverse Health Effects

Cardiovascular effects.

Most epidemiologic evidence suggests that OC use increases the risk of cardiovascular disease, in particular the risk of venous thromboembolism, myocardial infarction (MI), and stroke (Stadel, 1986). However, the risk of serious illness or death from cardiovascular disease that can be attributed to OC use is apparently concentrated among certain groups of women, primarily older women and women who smoke cigarettes.

At least 11 case-control and 4 cohort studies have found that OC use increases the risk of venous thromboembolism (Vessey, 1980). Results from those studies have shown that current OC use increases the risk of venous thromboembolism, although the increased risk does not appear to persist among past users. Furthermore, the risk among current users remains constant with increasing duration of OC use. The risk of both superficial and deep vein thrombosis among current OC users is directly related to the estrogen content of OCs: the higher the estrogen content of the OC, the greater the risk of venous thromboembolism (Stadel, 1986). The pathogenesis of venous thromboembolism among OC users probably involves an increase in the size of intravascular clots formed in response to thrombotic stimuli, most likely a result of estrogen-induced decreases in antithrombin III and plasminogen activators. Unlike the associations between OC use and MI and stroke, available studies have not found any interrelationship between OCs, venous thromboembolism, and cigarette smoking. The increased risk of venous thromboembolism is an important source of illness attributable to OC use but is a very infrequent cause of mortality (Stadel, 1986).

In contrast to the low attributable risk of death from venous thromboembolism associated with OC use, the increased risk of MI and stroke observed in women currently using OCs has been demonstrated to be an important source of the mortality risk attributable to OCs (Stadel, 1986). Current OC use increases the risk of MI, thrombotic stroke, and hemorrhagic stroke. The risk of MI and stroke associated with current OC use is strongly influenced by age and by the presence of other cardiovascular risk factors, such as cigarette smoking, hypertension, and diabetes. For example, the risk of MI that is attributable to OCs among nonsmoking women 30 to 39 years of age is about 4 cases per 100,000 current users per year, but it increases to about 185 cases per 100,000 current users per year among women aged 40 to 44 years who smoke heavily ( Table 3 ). The risk attributable to past OC use appears also to be concentrated among older women and older women who smoke heavily. The risk of adverse cardiovascular events among current OC users appears to be directly related to the estrogen content of the OCs; although less conclusive, risk may also be related to progestin content. The pathogenesis of MI and stroke among current OC users may be related both to the intravascular coagulation system and to the effects of increased blood pressure and metabolic changes.

Current Use of Oral Contraceptives (OCs), Cigarette Smoking, and Risk of Myocardial Infarction (MI).

Current OC use has been found to elevate blood pressure slightly in most women—about 1 to 2 mm Hg diastolic and 5 mm Hg systolic (Stadel, 1986). OC use leads to approximately a threefold to sixfold increased risk of overt hypertension. This risk has been observed to increase with increasing age and with increasing duration of OC use. Whether other risk factors for hypertension may be related to the increased risk attributable to OC use has not be established.

Metabolic Effects

The progestin component of OCs has been found to decrease the concentration of high-density lipoprotein-cholesterol (HDL-C), whereas the estrogen component has been found to increase HDL-C concentration (Stadel, 1986). Hence, the effects of different OC formulations on HDL-C concentration apparently depend on the specific estrogen-progestin content. A U.S. study provided information about 10 combination OCs: 3 lowered HDL-C concentrations, 2 had no effect, and 5 increased HDL-C levels (Bradley et al., 1978). If the progestin component has a strong anti-estrogen effect, the tendency of the estrogen component to increase HDL-C concentration may be overpowered (Stadel, 1986).

Current OC use has been found to decrease glucose tolerance among most women, although this decrease appears to be small, unrelated to duration of use, and only additive to the effects of other risk factors for impaired glucose tolerance (Stadel, 1986). This decrease in glucose tolerance is directly related to the estrogen content of the OCs, although there may be a relationship to the progestin content also. More important, OCs containing relatively small amounts of estrogen— < 50 micrograms of ethinyl estradiol—do not appear to decrease glucose tolerance to any appreciable extent.

Neoplastic Diseases

Epidemiologic studies clearly indicate that OC use increases the risk of hepatocellular adenoma (HCA), a rare, benign neoplasm of the liver. Although benign, HCA can cause serious abdominal hemorrhage and death, with a death-to-case ratio of approximately 8 percent (Rooks et al., 1979). Among women of reproductive age who have never used OCs or who used them for a short time, HCA develops at an annual rate of about 1.0 to 1.3 per million women 16 to 44 years of age. However, OC use is a strong risk factor for HCA, with a relative risk greater than 100 among women who have used OCs for 3 or more years compared with women who have used OCs for 1 year or less. The increased risk appears to be directly related to the duration of use, the age of the user, and the estrogen content of the OC. However, the absolute risk of HCA associated with OC use is small because of the rarity of the tumor. Among women who have used OCs for 5 years or longer, the attributable risk is estimated to be about 2 cases of HCA per 100,000 users per year (Stadel, 1986).

Epidemiologic studies have well demonstrated that OC use protects women from developing endometrial and ovarian cancers. However, the effect OCs may have on the risk for developing certain other malignancies remains unclear. Hepatocellular carcinoma and malignant melanoma have both been associated with OC use, although the strength of the associations has not been great. For this reason as well as the fact that those tumors are quite rare, the public health impact of a true positive association would not be great for either type of malignancy. Conversely, the debate about whether OC use increases the risk of cervical and breast cancers remains heated; some studies have found no effect on cancer risk, while others have found disturbing increases in risk. Because breast and cervical cancers are two of the most common cancers affecting women, contraceptive providers and epidemiologists feel an urgent need to resolve these discrepant results. However, as will be discussed subsequently, the possibility of a quick resolution to the controversies is unlikely.

Both case-control and cohort studies have assessed the relationship between OC use and malignant melanoma. Generally, they have not found substantial increases in the risk of melanoma associated with OC use (Stadel, 1986). Certain studies do suggest that OCs may increase the risk among certain subgroups of women, especially those who have used OCs for a long time (Ramcharan et al., 1981; Bain et al., 1982; Holly et al., 1983; Beral et al., 1984). Few studies have adequately addressed the risk by histologic type of melanoma. Future studies of this association will have several issues to consider, including the rarity of the tumor among women, the different histologic subtypes of melanoma, and the potentially confounding effects of exposure to sunlight.

The association between OC use and benign liver tumors, as well as a number of case reports of liver cancer among OC users, have led to theoretical concerns that OC use might increase the risk of malignant liver tumors. Three case-control studies published since 1983 have found increased risks of hepatocellular carcinoma among OC users (Henderson et al., 1983; Forman et al., 1986; Neuberger et al., 1986). Generally, the increased risk has been confined to women with a history of long-term OC use. However, each of the studies had few women in the case group ( < 30) and had methodological problems that may have biased the results.

In developed countries hepatocellular carcinoma is extremely rare among reproductive-aged women. In the United States in 1982 only 59 women died from liver cancer among approximately 52 million women aged 15 to 44 years (National Center for Health Statistics, 1982). Hence, even if OC use substantially increases the relative risk of liver cancer, the attributable risk would still be very low.

In many developing countries liver cancer is a much more common problem, primarily because of the relationship between hepatocellular carcinoma and chronic hepatitis B virus infection, which has a high prevalence in some regions. In those areas the possible interrelationships between OC use, hepatitis B infection, and liver cancer are more troublesome. Currently, the World Health Organization (WHO) is conducting a multicenter case-control study to address the relationship between OC use and liver cancer. Data are being collected from three developing countries with high rates of hepatitis B infection and liver cancer. It is hoped that results from this study will shed light on the relationship between OC use and this serious malignancy.

The potentially positive association between OC use and cervical cancer has added importance when considered in the setting of less developed countries. Surveillance information from developing countries, although sometimes fragmentary and incomplete, suggests that cancer of the cervix is the most frequent malignancy among women in those countries (Lunt, 1984). Unfortunately, screening efforts in those countries usually reach very limited segments of the female population. Unlike the situation in developed countries where provision of contraceptive services is usually accompanied by routine Papanicolaou (Pap) screening for cervical cancer, family planning programs in developing countries often do not have the resources to provide Pap screening for their clients.

To date, no definite causal relationship has been established between OC use and cervical cancer. Of 15 major epidemiologic studies, 8 have found no increased risk of cervical neoplasia and 7 have found significantly increased risks overall or increases among certain subgroups of users (Piper, 1985; Brinton et al., 1986; Ebeling et al., 1987; Irwin et al., 1988). At least some of the discrepancies may be due to methodological problems encountered in the various study designs, including (1) confounding bias caused by the effects of certain sexual behaviors that are well-recognized risk factors for cervical cancer; (2) overdiagnosis (by Pap screening) of cervical neoplasia among OC users; (3) a detection bias caused by increased Pap screening of OC users compared with nonusers; and (4) inappropriate comparison groups that include women who have used barrier methods, which are thought to protect against cervical cancer. (Swan and Pettiti, 1982; Piper, 1985) One recent case-control study from Costa Rica that considered the effects of sexual activity, history of sexually transmitted diseases (STDs), and the enhanced detection of cervical neoplasia among OC users found no elevated risk of invasive cervical cancer associated with OC use (Irwin et al., 1988). Although women who had used OCs had an increased risk of carcinoma in situ compared with never-users in the study, this increased risk was confined to women who had recently used OCs. Further, no increased risk of carcinoma in situ was found among subgroups in whom a history of Pap screening was not strongly linked to OC use. Both findings suggest that any elevated risk of carcinoma in situ among OC users may have been due to a bias caused by enhanced detection of disease. Another study of invasive cervical cancer from Maryland found no association with OC use (Celentano et al., 1987). However, two other recent studies, which also controlled for potentially confounding factors, found a 50 percent increased risk of invasive cervical cancer among women who had ever used OCs; women who used OCs for 5 or more years had about a twofold increase in risk (Brinton et al., 1986; Ebeling et al., 1987).

Results from these recent studies of the OC—cervical cancer relationship remain conflicting, even though most of the potential methodological problems were considered. OCs probably do not dramatically increase the overall risk of cervical dysplasia or cancer, although long-term use or use by specific subgroups of women may increase the risk. Furthermore, little is known about the relationship between OC use and human papillomavirus infection, which is thought to have an important role in cervical carcinogenesis. Further research is needed to clarify these complex relationships. Certainly, OC users, both current and past, need to be screened regularly with Pap smears. Whether or not using OCs is a risk factor for cervical cancer, it provides an ideal opportunity to screen sexually active women for this serious reproductive system cancer.

More than 15 published studies have reported that, overall, use of OCs does not appear to increase or decrease a woman's risk of breast cancer (Prentice and Thomas, 1987). However, many of those investigations were conducted in the 1970s, little more than 10 to 15 years after OCs were introduced. In these earlier investigations researchers had limited ability to study the long-term effects of OC use, particularly the effects of long duration of use, of distant time since first use, of use at specific ages, and of use in relation to other key reproductive events related to a woman's risk of developing breast cancer. Additionally, many of the studies of the OC–breast cancer relationship were not large enough to examine the relationship according to specific OC formulations and among certain high-risk subgroups of women.

To date, the CASH Study is the largest study designed to assess the risk of breast cancer associated with OC use (CASH, 1986). The study was a population-based case-control study conducted in eight regions of the United States from 1980 to 1982. Detailed information about reproductive history, contraceptive use, family history of cancer, and personal characteristics and habits was collected from 4,711 women with newly diagnosed breast cancer and from 4,676 control women. Case and control women were from 20 to 54 years of age. Compared with women who had never used OCs, women who had used OCs had a relative risk of breast cancer of 1.0 (0.9–1.1); even women who had used OCs for 15 or more years had no increased risk. None of the 12 OC formulations most commonly used in the United States were associated with a statistically significant increased risk of breast cancer. Analyses also showed no increase in risk among high-risk subgroups of women, including women with a history of BBD or a family history of breast cancer or those who were nulliparous or older at first term pregnancy.

Nonetheless, despite many studies indicating that OC use apparently does not increase the overall risk of breast cancer, controversy remains concerning whether long-term OC use, use at an early age, or use before the first term pregnancy might increase breast cancer risk (Skegg, 1988). Several recent studies have found increases in risk among certain subgroups of women. An analysis published in 1983 suggested that women who used certain OC formulations classified as ''high progestin'' before the age of 25 appeared more likely to develop pre-menopausal breast cancer than women who did not use OCs before age 25 (Pike et al., 1983). In the same year a report from England suggested that women with long-term OC use before their first child was born had an increased risk of premenopausal breast cancer compared with women who did not use OCs before the birth of their first child (McPherson et al., 1983). A 1985 report described results from an analysis using a subset of data from the CASH Study that replicated the analyses from the two 1983 reports (Stadel et al., 1985). In this analysis 2,088 women who had breast cancer and were from 20 to 44 years old were compared with 2,065 control women in the same age group. No significant increase or decrease in risk was observed among women who used high-progestin OCs before age 25, even when duration of use exceeded 6 years. Similarly, women who used OCs before their first term pregnancy did not have an increased risk, even when duration of use exceeded 4 years.

In 1986 two additional conflicting reports were published (Meirek et al., 1986; Paul et al., 1986). Analyses from a case-control study conducted in Scandinavia found a risk of premenopausal breast cancer among women with long-term OC use and use before the first term pregnancy (Meirek et al., 1986). The investigators reported a twofold increase in risk of breast cancer among women who used OCs for as long as 12 years. In contrast, analyses from a New Zealand case-control study did not find elevations in risk associated with OC use, even among women who had used OCs for a long time and who started taking them at an early age or among women who used OCs before their first term pregnancy (Paul et al., 1986).

A recently published analysis from the CASH Study examined in detail the risk of breast cancer in relation to early use of OCs (Schlesselman et al., 1988). The study found no evidence that use of OCs in the distant past increased breast cancer risk through age 54. Parous women who had used OCs for more than 6 years before their first term pregnancy, at 10–14 years after that pregnancy, were found to have a risk of breast cancer relative to nonusers of 1.1 (0.3–3.9). Among nulliparous women with more than 6 years of OC use, the relative risk of breast cancer at 10–14 years after they last used OCs was 0.6 (0.1–3.7).

Epidemiologists continue trying to disentangle the reasons for the discrepancies among the published studies (McPherson et al., 1986; McPherson and Drife, 1986; Anonymous, 1986; Schlesselman et al., 1987; Skegg, 1988). McPherson et al. (1986) have suggested that any possible risk of breast cancer associated with OC use at early ages may not become apparent for at least 20 years. Women born in the 1940s who used OCs in the 1960s will reach the ages of highest risk for breast cancer by the year 2000. If OC use at young ages is a risk factor for breast cancer, and if at least 20 years is required between exposure to OCs and the diagnosis of breast cancer, then these women might be expected to be diagnosed with breast cancer some time during the next 20 years. Under these assumptions, researchers may not be able to detect such a relationship at the present time.

The conflicting reports about the possible relationship between OC use and breast cancer risk, particularly use at an early age and before first term pregnancy, are confusing and troublesome. However, the preponderance of epidemiologic studies suggests that, overall, OCs do not increase the risk of breast cancer. If they do increase the risk in certain subgroups of women, the increase is not great and is generally confined to long-term users. Most experts believe that current recommendations for OC use should not be changed because of the continuing OC-breast cancer controversy. As women who used OCs in the 1960s reach the ages of highest risk for breast cancer, investigators should vigorously pursue opportunities to continue studying the long-term effects of OC use on breast cancer risk.

Other Effects

Several epidemiologic studies published in the 1970s reported that using OCs increased a woman's risk of gallbladder disease. Results from two large cohort studies from the United Kingdom published in 1982 better clarified the relationship between OCs and gallbladder disease (Layde et al., 1982; RCGP, 1982). Each study found that the increased risk appeared to be confined to recent users and to short-term users. No differences in risk were found with differing estrogen or progestin doses. The authors of both studies concluded that using Ocs apparently accelerated the development of gallbladder disease among susceptible women, rather than increased the overall lifetime risk.

A twofold to threefold increase in the prevalence of chlamydia trachomatis infection of the cervix among OC users has been demonstrated in 12 epidemiologic studies (Washington et al., 1985). Three reasons for this increase in risk have been suggested: (1) greater sexual activity among OC users than nonusers, (2) enhanced detection of chlamydial infection because of increased cervical ectropion induced by OC use, and (3) a direct effect of OC use on the risk of chlamydial infection. Three of the epidemiologic studies measured sexual activity and found no increase among OC users; furthermore, several epidemiologic studies have not found an increased risk of gonococcal infection among OC users (Washington et al., 1985). Whether or not it is merely easier to detect chlamydia infection among women who use OCs cannot be easily assessed and remains unresolved.

• Intrauterine Devices

The first IUDs that were widely used, such as the Lippes Loop TM and Saf-T-Coil TM , were made of inert plastic. In the 1970s a second generation of IUDs was introduced in which the plastic IUD acted as a carrier for metal or hormonal substances (Piotrow et al., 1979). These medicated devices included the Copper-7, Copper-T series, and the Progestasert TM . More recently a new and improved copper IUD, the Copper-T 380A, was developed; it may soon be the major IUD available in most countries (Treiman and Liskin, 1988).

The IUD is a highly effective contraceptive, with method failure rates of about 1 percent per year for medicated IUDs and 2 percent per year for nonmedicated ones ( Table 2 ). Because of undetected IUD expulsion, the user failure rate for IUDs is estimated to be somewhat higher, about 6 percent per year.

Because IUDs apparently prevent both intrauterine and ectopic pregnancies, the overall risk of ectopic pregnancy among IUD users is probably decreased compared with women who use no contraception. A 1981 study reported that current IUD users had a relative risk of ectopic pregnancy of 0.4 (0.3–0.6) compared with women using no contraception (Ory, 1981). However, about 5 percent to 15 percent of IUD-associated pregnancies are ectopic as IUDs seem to be more effective at preventing intrauterine pregnancies.

No major noncontraceptive health benefits are linked to IUD use. Progesterone-elaborating IUDs tend to decrease menstrual blood loss and dysmenorrhea, which can be viewed as a benefit for those women in whom it occurs (Hatcher et al., 1988).

Four major health risks have been associated with IUD use: (1) spontaneous abortion, which may rarely progress to septic abortion; (2) uterine perforation; (3) PID; and (4) tubal infertility. Based on information from studies done primarily in the United States and other developed countries, estimates for the annual mortality risk attributable to IUD use are between 1 and 2 deaths per 100,000 women (Ory et al., 1983). Mortality rates from IUD use may be somewhat higher in developing countries because of delays in treating complications or lack of access to medical facilities.

Although pregnancy rates are low among IUD users, complications may occur in women who do become pregnant. If the IUD is left in place, the chance of spontaneous abortion is 50 percent. If the IUD is removed, this rate drops to 25 percent (Hatcher et al., 1988). Septic abortion is a rare but sometimes fatal complication (10 per 100,000) that may occur if the IUD is left in place after the first trimester of pregnancy (Ory et al., 1983). If the IUD is removed as soon as the pregnancy is diagnosed, most instances of septic abortion can be prevented.

Perforation of the uterus may occur when an IUD is inserted, although this injury is often undetected and usually not serious. The incidence of perforation is unknown but is probably less than 1 percent (Hatcher et al., 1988). Very rarely the IUD is extruded into the abdominal cavity, requiring laparotomy to remove it. The risk of perforation during insertion increases substantially in two subgroups of women: lactating women and women within 8 weeks of delivery, because they have softer uterine musculature; at these times the risk of perforation may be increased substantially (Heartwell and Schlesselman, 1983).

Most epidemiologic studies of the issue have found that IUD users have an increased risk of PID (Grimes, 1987). This finding contrasts with all other modern methods of temporary contraception, which seem to protect a user from developing PID.

PID is usually but not always the result of an STD, such as gonorrhea or chlamydial infection. The overall incidence of PID varies greatly in different populations and depends mainly on sexual behaviors. The incidence of PID among IUD users also varies substantially. In a Scandinavian study of women with gonorrhea, 24 percent of IUD users developed PID (Ryden et al., 1979). Results from a large cohort study of married women in the United Kingdom showed a PID rate of 0.15 per 100 woman-years (Vessey et al., 1981). Clinical trials that determined rates of IUD removal because of PID found rates about eight times greater than the study from the United Kingdom, up to 1.22 per 100 woman-years (Siven and Stern, 1979).

The Dalkon Shield TM , an IUD used in the 1970s but no longer available, has been associated with a high risk of PID in several studies (Grimes, 1987). Women using IUD types other than the Dalkon Shield have been found to have about 1.5 to 2.0 times greater risk of PID than women using no contraceptive method. Most studies that have looked at the relationship of PID risk to the timing of IUD insertion have found that much of the increased risk is probably confined to the first few months after insertion. A recently published analysis has found that IUD users who are in mutually monogamous sexual relationships probably have little increased risk of PID associated with their IUD use (Lee et al., 1988). Much of the increased risk of PID seen among IUD users may be confined to women who are at increased risk for developing STDs.

One of the most important and serious sequellae of PID is tubal infertility. Results from a large cohort study of women with surgically confirmed PID have demonstrated that these women have an increased risk of subsequent tubal infertility (Westrom, 1987). The data showed that, among the women with PID who were subsequently exposed to a chance of pregnancy, infertility occurred in 11 percent after one episode of PID, 23 percent after two episodes, and 54 percent after three episodes.

Until recently little epidemiologic evidence directly linked IUD use with infertility. Results from most clinical trials of IUDs found that more than 70 percent of women conceive within 12 months of IUD removal (Liskin and Fox, 1982).

A large cohort study from the United Kingdom found that within 2 years of removal 92 percent of former users had given birth (Vessey et al., 1978). However, two U.S. case-control studies reported that the risk of tubal infertility among nulliparous women who had ever used IUDs was about twice that of those who had never used them (Daling et al., 1985; Cramer et al., 1985).

Both of these case-control studies found different risks of tubal infertility associated with different types of IUDs (Daling et al., 1985; Cramer et al., 1985). Women who had used the Dalkon Shield had the highest risk of tubal infertility. The lowest risk was seen among women who had used copper IUDs, while women who used the Lippes Loop or Saf-T-Coil IUDs had intermediate risks. Although these findings were consistent between the two studies, the numbers of users of specific IUD types were small, and the differences may have been due to chance alone.

The incidence of IUD-associated infertility is unknown, although it is probably less than the incidence of IUD-associated PID. The increased risk of infertility is presumably related to the increased PID risk associated with IUD use, even if PID is never recognized clinically. Cramer et al. (1985) found that women who reported having only one sexual partner had no increased risk of tubal infertility associated with IUD use.

• Barrier Methods

Because of the potential for preventing transmission of STDs, such as acquired immune deficiency syndrome, researchers are focusing new attention on barrier methods of contraception—condoms, diaphragms, spermicides, and sponges. Generally, barrier methods are less effective at preventing pregnancy than are OCs, IUDs, sterilization, injectables, and implants. Further, the effectiveness of barrier methods is extremely user dependent; improper use by unmotivated users can result in high failure rates. Side effects are minimal; consequently, the main risks associated with barrier methods are complications from unintentional pregnancy (Ory et al., 1983).

Discontinuation of use of barrier methods is common, both because they have higher risks of failure and because they may be obtrusive and less convenient to use (Sherris et al., 1984). But an important advantage of barrier methods is their protection against various STDs. Barrier methods also protect against acute PID and the resulting tubal infertility by keeping organisms that cause PID—such as Neisseria gonorrhoeae and Chlamydia trachomatis—from infecting the lower genital tract and from ascending into the upper genital tract (Kelaghan et al., 1982; Cramer et al., 1987).

Condoms are a safe, reversible method of birth control increasingly being used to prevent both pregnancy and STDs. The estimated method failure rate for condom use (without spermicide) is 2 percent per year, while the user failure rate is 12 percent ( Table 2 ). The effectiveness of condoms as both a contraceptive and a disease prophylactic depends on consistent and proper use. If couples begin to rely solely on condoms for protection against both pregnancy and infection, they could experience a substantial increase in the number of accidental pregnancies from incorrect or inconsistent use (Trussell and Kost, 1987). As condom use increases, acceptability and compliance will be important to monitor.

In vitro studies have demonstrated that latex condoms are effective barriers to herpes simplex virus type 2 (Conant et al., 1984; Judson et al., in press), Chlamydia trachomatis (Judson et al., in press), cytomegalovirus (Katznelson et al., 1984), and human immunodeficiency virus (HIV) (Conant et al., 1986; Rietmeijer et al., 1988). Natural membrane condoms may give less protection against viral STDs than latex ones, which contain smaller pores (Centers for Disease Control, 1988). Because using condoms prevents semen deposition, their use should also reduce transmission of organisms that may be present in semen, such as Neisseria gonorrhoeae, hepatitis B virus, Trichomonas vaginalis, and HIV (Stone et al., 1986).

Epidemiologic data relating to condom use and the prevention of STDs are limited. Several studies have shown that condom users, their partners, or both have a lower frequency of gonorrhea (Barlow, 1977; Hooper et al., 1978). Preliminary epidemiologic data suggest that using condoms may protect against sexual transmission of HIV infection (Fischl et al., 1987; Centers for Disease Control, 1987). Recent studies of prostitutes have also suggested a protective relationship between condom use and HIV infection (Smith and Smith, 1986; Centers for Disease Control, 1987; Mann et al., 1987).

However, these studies were based on observational data, and condom users are likely to differ from nonusers in important characteristics that may be related to the risk of acquisition of STDs (Feldblum and Fortney, 1988). Although conclusive epidemiologic evidence is lacking, available data suggest that the use of condoms is an effective preventive measure against STDs (Horsburgh et al., 1987). Failure of condoms to protect against STDs is probably explained by user failure more often than by product failure (Centers for Disease Control, 1988). The use of spermicides is considered a useful adjunct to condoms because spermicides can inhibit in vitro the growth of a broad range of sexually transmitted pathogens (Cramer et al., 1987; Francis and Chin, 1987).

Spermicides and the Contraceptive Sponge

Spermicides are chemical agents that inactivate sperm in the vagina before the sperm can move into the upper genital tract. Spermicides in use today include nonoxynol-9, octoxynol-9, and menfegol, although the latter is not available in the United States. Spermicides containing mercuric compounds, rejected as unsafe by the U.S. Food and Drug Administration (FDA), are still marketed in some Latin American countries and elsewhere (Sherris et al., 1984). Inert carriers of the spermicide include foams, jellies, creams, and suppositories; newer carriers include foaming suppositories (Neo Sampoon TM ) and spermicide-impregnated sponges (Today TM ).

The type of spermicidal agent or carrier has little effect on failure rates. The method failure rate is estimated to be about 3 percent per year; however, the user failure rate, at 21 percent per year, is much higher ( Table 2 ), largely because use must be premeditated. Furthermore, because spermicides are messy and can be irritating to mucous membranes, women often stop using them (Sherris et al., 1984). Protection from pregnancy, however, can be increased considerably if spermicides are used in conjunction with other barrier methods such as diaphragms or condoms.

Among nulliparous women the failure rates for the contraceptive sponge are comparable to the failure rates for the diaphragm; the method failure rate is 5 percent per year and the user failure rate is 18 percent per year ( Table 2 ). However, among parous women the method failure rate is 8 percent and the user failure rate is 28 percent.

Both laboratory evidence and clinical evidence suggest that spermicides protect against various STDs (Stone et al., 1986). In vitro studies have shown that spermicides inhibit the growth of Neisseria gonorrhoeae (Singh et al., 1972; Cowan and Cree, 1973) and inactivate herpes simplex virus type 2 (Singh et al., 1976) and HIV (Hicks et al., 1985). Although epidemiologic evidence is sparse, the virucidal effects of spermicides may provide some protection against cervical cancer, since the cancer may be initiated or promoted by a sexually transmitted virus such as human papilloma virus (Spring and Gruber, 1985). Several epidemiologic studies have found that spermicides protect users from gonorrhea infections (Jick et al., 1982; Quinn and O'Reilly, 1985), especially when used with condoms or diaphragms (Austin et al., 1984). A clinical trial among high-risk women using contraceptive sponges impregnated with nonoxynol-9 demonstrated protection against chlamydial and gonorrheal infections (Rosenberg et al., 1987).

One epidemiologic study suggested a connection between spermicides used near the time of conception or during pregnancy and the risk of congenital defects (Jick et al., 1981). Since that report, several larger and better designed studies have failed to confirm the association (Huggins et al., 1982; Mills et al., 1982; Shapiro et al., 1982; Cordero and Layde, 1983).

Additional health risks have been associated with the contraceptive sponge, a newer type of spermicidal carrier. Sponge users may be at increased risk of vaginal candidiasis, possibly because nonoxynol-9 allows candidal overgrowth (Rosenberg et al., 1987). Of greater health consequence is a possible association between using the contraceptive sponge and developing toxic shock syndrome (TSS); sponge users have a relative risk of 10.5 (2.1–52.7) compared with women using no barrier method (Schwartz et al., 1989). Because TSS is an extremely rare disease, the absolute risk of sponge users developing TSS is quite small; however, because TSS is a serious illness, physicians and sponge users should be aware of the symptoms and alert to the possibility (Faich et al., 1986; Schwartz et al., 1989). Postpartum women and women who have had TSS should not use the sponge, and women should never leave the sponge in the vagina for more than 30 hours (Reingold, 1986).

Diaphragm with Spermicide

Diaphragms used with spermicidal cream or jelly are a safe method of contraception and, when used correctly and consistently, can be an effective contraceptive. Because diaphragms/spermicides are inconvenient to use, only highly motivated women will experience low failure rates. Although the method failure rate is estimated to be about 3 percent per year, the user failure rate is much higher, about 18 percent per year ( Table 2 ). Clinicians should consider how motivated their patients are before advising diaphragm use (Sherris et al., 1984).

As with other barrier methods, diaphragm/spermicide use may have several noncontraceptive health benefits. This method appears to protect against gonorrhea, PID, and tubal infertility (Jick et al., 1982; Kelaghan et al., 1982; Cramer et al., 1987). Several case-control studies found cervical dysplasia and cervical neoplasia less common among diaphragm users than among other women (Wright et al., 1978; Harris et al., 1980; Celentano et al., 1987). Because diaphragms are almost always used with spermicides and spermicides alone may protect against various STDs, the separate protective effects of diaphragms on specific conditions may be difficult to measure (Stone et al., 1986).

As with the contraceptive sponge, diaphragms have been associated with a significantly higher risk of TSS (Hymowitz, 1981; Baehler et al., 1982; Schwartz et al., 1989). In one case-control study diaphragm users had a relative risk of TSS of 11.7 (2.5–56.1) compared with nonusers; however, the estimated absolute risk of TSS associated with diaphragm use was low, about 2.25 cases per 100,000 users per year (Schwartz et al., 1989). A less serious but more frequent complication associated with diaphragm use is urinary tract infections; the relative risks for diaphragm users developing a urinary tract infection compared with nonusers ranges from 2.0 to 3.0 (Foxman and Frerichs, 1985; Fihn et al., 1985; Vessey et al., 1987). Better fitted diaphragms and urination after intercourse may reduce the risk of urinary tract infections (Foxman and Frerichs, 1985). Women at particular risk for urinary tract infections, such as those with recurrent infections, should probably consider other contraceptive methods.

Cervical Caps

Cervical caps are cup-shaped devices, held in place by suction, that fit over the cervix (Hatcher et al., 1988). When used with spermicides, their effectiveness is comparable to that of diaphragms, with a method failure rate of about 5 percent per year and a user failure rate of 18 percent per year ( Table 2 ). Cervical caps have not been widely used; hence, little published research is available. Reports from small studies suggest that about half the women who want to use the cap cannot be fitted. Many other women discontinue use because of odor problems, difficulty in insertion or removal, or dislodgement during intercourse (Ory et al., 1983). Advantages are that the cap can be left in place longer than 24 hours and that it can be inserted many hours or even a day or two before coitus (Sherris et al., 1984). Although potential health risks and benefits associated with the cervical cap are probably similiar to those associated with the diaphragm, available data are too limited to document them (Hatcher et al., 1988).

• Long-Acting Methods

Several long-acting contraceptive methods now available are highly effective, convenient to use, and give protection from pregnancy for 1 month to 5 years. All contain some kind of progestin. Disturbance of the menstrual cycle is the most common side effect of all progestin-containing contraceptives and is the major reason women stop using them.

Injectables

Two long-acting injectable progestins—depot-medroxprogesterone acetate (DMPA; Depo-Provera TM ) and norethindrone enanthate (NET; Noristerat TM )— are the most widely used and studied of several injectable contraceptives available. DMPA is approved for contraception in at least 90 countries, NET in more than 40 (Liskin et al., 1987). At present neither is licensed for use as a contraceptive in the United States.

Injectables are highly effective: the estimated method failure rate is 0.3 percent per year for DMPA, given every 90 days, and 0.4 percent per year for NET, given at 8-or 12-week intervals ( Table 2 ). Because minimum compliance is necessary, the user failure rates are approximately equal to the method failure rates. Injectables prevent pregnancy in several ways. Possible mechanisms include inhibiting ovulation; thickening cervical mucus; and altering the endometrial lining, which inhibits implantation (Liskin and Quillin, 1982).

Considerable controversy regarding possible cancer risks has been associated with DMPA and NET, chiefly stemming from data from animal studies suggesting that DMPA use could increase the risk of breast and endometrial cancers (WHO, 1986a). Although the applicability of these animal models is debatable and human studies have either failed to demonstrate these relationships or are inconclusive (Liang et al., 1983; WHO, 1986a; Lee et al., 1987), the possibility of increased risk of cancer among DMPA users was one reason the FDA did not approve DMPA for contraceptive use in the United States (Sun, 1984).

In 1986 preliminary results were published from an ongoing case-control study conducted by WHO concerning the relationship between DMPA and breast cancer (WHO, 1986a). This is the largest epidemiologic study of the DMPA-breast cancer relationship published to date. Women who had ever used DMPA had a risk of breast cancer of 1.0 (0.7–1.5); no increase in risk was seen even for long-term users. Conversely, a recent study in Costa Rica found that DMPA users had an elevated risk of breast cancer of 2.6 (1.4–4.7); however, no dose-response effect was found (Lee et al., 1987). Because of the small number of DMPA users in the study and the lack of a dose-response relationship, the authors considered the results to be inclusive.

Another analysis from the same WHO study found that the risk of invasive cervical cancer was slightly higher for long-term DMPA users than for never-users (relative risk of 1.4 [0.9–2.2]); however, results were considered inconclusive because of the small number of long-term DMPA users as well as the lack of a consistent trend with duration of use (WHO, 1986a). Results from the Costa Rica study showed no increase in risk of either invasive cervical cancer or carcinoma in situ associated with DMPA use (Oberle et al., 1988).

Although DMPA and NET have yet to be conclusively linked to any human cancer, epidemiologic studies have been hindered by small sample sizes and short durations of exposure. Whether injectable contraceptives are associated with any cancer will be resolved only after additional data have accumulated (WHO, 1986a).

Reported metabolic effects of DMPA and NET use include changes in blood pressure as well as changes in insulin, cholesterol, and triglyceride levels; however, the findings are inconsistent and have shown no clear clinical significance (WHO, 1986b; Liskin et al., 1987). Concern over cholesterol levels among women who use DMPA or NET is mainly due to the reported cardiovascular problems associated with OC use, generally thought to be caused by the estrogen component of the pill (Rosenfield et al., 1983). Lower levels of HDL-C have been reported among women who were taking OCs with a high progestin potency or a progestin alone (Bradley et al., 1978). Most studies of DMPA users have found either no change in total cholesterol and triglycerides or a decrease, a possibly beneficial effect (Liskin et al., 1987). However, a few studies have reported an increase in cholesterol with longer use of DMPA or a decrease in HDL-C, both possibly adverse effects. The only study involving NET also found a decrease in HDL-C (Fotherby et al., 1982). The clinical significance of these decreases in HDL-C is uncertain; to date, no associations between DMPA or NET use and increased incidence of cardiovascular disease have been reported. Trials are under way in five countries to measure changes in lipid metabolism in DMPA and NET users (Liskin et al., 1987).

Unlike combination OCs, DMPA and NET appear to have little effect on the coagulation system (Liskin et al., 1987). Most laboratory studies have found little change in the coagulation and fibrinolytic systems that affect blood clotting.

The most consistently reported side effect of DMPA and NET use is a change in menstrual pattern: more than two-thirds of DMPA users and one-half of NET users have no regular menstrual cycles during the first year they use these contraceptives (Liskin et al., 1987). Amenorrhea or irregular, unpredictable bleeding episodes are the most common problems (WHO, 1978, 1987) and the principal reasons that women stop using injectables. Amenorrhea, more frequent with DMPA than NET, is probably the most upsetting change because women cannot be sure they are not pregnant (Liskin et al., 1987). Prolonged bleeding or spotting can be disturbing, especially if local customs restrict the activities of menstruating women. The occurrence of heavy bleeding requiring medical attention is rare, found among about 0.5 percent of users. In fact, because bleeding is often lighter than normal, increased hemoglobin levels among some users have been reported (WHO, 1986b).

Studies of children exposed to DMPA from breast milk have found no measurable consequences, even when followed up to 10 years after exposure (Liskin et al., 1987). This is not an unexpected finding, for very little of the hormone is transmitted in breast milk.

Neither DMPA nor NET appears to have any permanent effect on fertility (Liskin et al., 1987). However, resumption of ovulation and fertility is delayed; ovulation can be inhibited for 4 to 9 months or more after the last injection (Pardthaisong et al., 1980; Affandi et al., 1987). Although return to fertility is comparable to that seen with OC and IUD use, because of fears about permanent infertility, some family planning programs use injectables only among higher-parity women (Liskin et al., 1987). In fact, injectable progestins may protect women from PID, a major cause of infertility, by causing changes in cervical mucus (Gray, 1985).

Injectable progestins may also protect against endometrial and ovarian cancers. Excess estrogen is known to increase the risk of endometrial cancer, while progestins mitigate this effect (Rosenfield et al., 1983). Further, several studies have demonstrated a negative association between the use of combination OCs and endometrial cancer, a protective effect thought to be caused by the progestin component. Preliminary results from a WHO case-control study found that DMPA users had a relative risk of 0.3 (0.04–2.4) compared with never-users; however, data were based on just 52 women with endometrial cancer, only one of whom had ever used DMPA (WHO, 1986a).

Even fewer data exist on the association between ovarian cancer and DMPA use. However, several studies have demonstrated a negative association between OC use and ovarian cancer, perhaps due to the effects of an ovulation (Rosenfield et al., 1983). Because injectable progestins usually prevent ovulation, there is at least a theoretical possibility that use of DMPA or NET might reduce the risk of ovarian cancer. Preliminary results from the WHO study support this possibility: DMPA users had a relative risk of ovarian cancer of 0.7 (0.3–1.7) compared with never users, based on 7 exposed cases and 74 exposed controls (WHO, 1986a).

Several new types of injectables are currently in use or under development. Injectable microspheres and microcapsules release hormone at a more constant rate, and preliminary trials have found fewer side effects than with DMPA or NET (Liskin et al., 1987). However, as with all progestational agents, irregular menstrual bleeding is a common side effect. Estrogen-progestin combinations that are injected monthly are being used in Latin America and China; preliminary results have shown highly effective protection and fewer problems with bleeding irregularities.

The NORPLANT® subdermal implant system is another highly effective, long-acting progestational contraceptive method (Liskin et al., 1987). It is currently being considered by the FDA for use in the United States. Developed by the Population Council, NORPLANT® implants come in two forms. The first and more widely used system, NORPLANT® consists of six silastic rods, each about 1 inch long and 0.1 inch in diameter, containing 35 milligrams of the progestin levonorgestrel. The newer system, NORPLANT-2®, consists of two rods, each containing 70 milligrams of levonorgestrel. With both systems, rods are implanted under the skin, usually in the upper arm; the hormone is then released at a continuous, slow rate. Insertion and removal require a minor surgical procedure performed by trained health care personnel; however, once implanted, no further action is required for several years.

Both systems provide long-term protection from pregnancy. NORPLANT® is highly effective for 5 years, NORPLANT-2® for at least 3 years. In the first year of use the average reported failure rate is 0.2 percent ( Table 2 ). However, the failure rate may be slightly higher among obese women. The mechanisms for pregnancy prevention are probably similar to those for the injectable contraceptives.

The rate of ectopic pregnancy among NORPLANT® users, about 1.5 per 1,000 woman-years, is about the same as the rate among women using copper and unmedicated IUDs (Liskin et al., 1987). Because the rate is lower than that for women using no contraception, NORPLANT® users can be considered to be protected from ectopic pregnancy.

As with injectables, the most common side effect of implants is disturbance of the menstrual cycle. Bleeding irregularity, the most frequent reason that women discontinue use of the method (Salah et al., 1987; Pasquale et al., 1987), causes 2 percent to 7 percent of women to stop using implants in the first year (Liskin et al., 1987). However, episodes of abnormal bleeding diminish with duration of use (Salah et al., 1987; Diaz et al., 1987), and the implants can be removed immediately if there are any disturbing side effects.

Transient ovarian cysts occur in a small percentage of women using NORPLANT® (Salah et al., 1987; Diaz et al., 1987); although the cysts regress eventually, they have been a reason for implant removal (Pasquale et al., 1987). Permanent infertility does not appear to be a concern; several studies have shown that fertility quickly returns after implants are removed (Diaz et al., 1987; Affandi et al., 1987).

Generally, no changes in several metabolic indicators have been found secondary to NORPLANT® use, including liver function, carbohydrate metabolism, blood coagulation, blood pressure, or body weight (Liskin et al., 1987). Studies of lipid metabolism in NORPLANT® users have produced conflicting results. However, no epidemiologic studies of cardiovascular complications among NORPLANT® users have been completed.

• Tubal Sterilization

Since the 1930s more than 95 million women worldwide have undergone tubal sterilization, making it the most widely used contraceptive method in the world (Liskin et al., 1985). The popularity of tubal sterilization continues to grow rapidly in many countries, which suggests that the estimate of the number of women who have had the procedure may be a conservative one. Currently, more than 15 percent of married women of reproductive age have undergone tubal sterilization in countries as diverse as Brazil, Panama, South Korea, Thailand, and the United States. In China an estimated 27 percent of women have undergone tubal sterilization. Tubal sterilization has been very popular in the United States, Latin America, the Caribbean, and in much of Asia. Africa and the Middle East have the lowest prevalence of tubal sterilization.

Tubal sterilization procedures can be characterized by (1) timing with respect to pregnancy, (2) the surgical approach to the fallopian tubes, and (3) the method of tubal occlusion. Tubal sterilization can be performed shortly after vaginal delivery, concurrently with cesarean section, at the time of induced abortion, or remote from pregnancy termination. In the latter instance the procedure is known as interval tubal sterilization.

Surgery for most tubal sterilizations requires an abdominal incision. For either postpartum or interval sterilizations, an abdominal incision 2 to 5 centimeters long, termed a minilaparotomy, allows the surgeon access to the fallopian tubes (Ross et al., 1985).

Laparoscopic tubal sterilization is becoming increasingly popular, particularly in developed countries. For laparoscopic procedures the abdominal incision is usually only about 1 centimeter long. Two general methods of inserting the laparoscope are used. In the first, termed closed laparoscopy , a surgeon uses an insufflating needle, a sharp trocar, or both to enter the abdominal cavity before inserting the laparoscope. An alternative technique called open laparoscopy attempts to minimize the risk of intra-abdominal injury caused by the insufflating needle or trocar by combining features of minilaparotomy and closed laparoscopy. Although open laparoscopy requires more time than closed laparoscopy, it reduces the chance of trauma to major blood vessels and the gastrointestinal tract and thus is inherently safer, especially for facilities that do not have the equipment and personnel necessary to handle serious surgical complications.

Alternative surgical approaches include the vaginal approach and the transcervical approach. Although the vaginal approach produces no visible scar, it is used less frequently because of the increased risk of pelvic infection (Ross et al., 1985). A transcervical approach, involving instillation of a sclerosing agent into the fallopian tubes, is widely used only in China.

The fallopian tubes can be occluded by ligation (with or without resection), by coagulation using unipolar or bipolar current, or by mechanical occlusion with silastic bands or clips. Tubal occlusions for postpartum laparotomies are generally done by ligation. All of these techniques can be used for interval sterilization, but the methods of occlusion for laparoscopy are limited to the use of coagulation or mechanical devices. Unipolar coagulation involves use of an electrical current that passes into the tube and through the patient to a ground plate attached to the patient. This system, which has resulted in fatal thermal bowel injuries (Peterson et al., 1981a), has largely been replaced in the United States by a bipolar coagulation technique that includes only the tissue in the grasping forceps as an integral part of the electrical circuit, thereby reducing the risk of serious thermal injuries (Hulka et al., 1987).

With the exception of conventional laparotomy, all surgical approaches and methods of tubal occlusion can be safely and effectively performed using local anesthesia. Because of the hazards inherent in the use of general anesthesia, the World Federation of Health Agencies for the Advancement of Voluntary Surgical Contraception (1984) advocates using local anesthesia for uncomplicated procedures.

A pregnancy that is identified after sterilization may have occurred because of conception before sterilization or because the operation was not successful. Conception before sterilization, called a luteal-phase pregnancy, is estimated to occur in about 2 to 3 per 1,000 interval tubal sterilizations (Chi and Feldblum, 1981). The most effective means of reducing the risk of luteal-phase pregnancy is to perform the sterilization before the estimated date of ovulation (Grubb and Peterson, 1985).

Rates of true sterilization failure vary by method of tubal occlusion, surgical expertise, and other factors, such as whether a woman has tubal disease. Overall rates are estimated to be between 0.2 percent and 0.4 percent per year ( Table 2 ). No studies currently available permit rigorous comparison of failure rates by method of tubal occlusion, though one such study with the potential to do so is in progress in the United States. Since 1978 a multicenter cohort study conducted by the Centers for Disease Control has enrolled approximately 12,000 women undergoing tubal sterilization. These women are currently in various stages of a planned 5-year follow-up. Final study results will not, however, be available until the early 1990s.

When sterilization fails, the relative likelihood of ectopic gestation appears to be increased. Further, the risk seems to vary by method of tubal occlusion, with highest risk of ectopic pregnancy following electrocoagulation (Bhiwandiwala et al., 1982). The absolute likelihood of ectopic pregnancy after sterilization is actually reduced, however, relative to the risk a woman would incur when not using any contraception or using an IUD (DeStefano et al., 1982).

Studies from around the world suggest that tubal sterilization is a remarkably safe surgical procedure; however, more women die from tubal sterilizations than men die from vasectomies. Case-fatality rates for tubal sterilization have been estimated in reports from Europe, the United States, India, and Bangladesh. A French survey of approximately 100,000 laparoscopic procedures (including those for purposes other than sterilization) estimated a case-fatality rate of 20 per 100,000 procedures (Mintz, 1977). A prospective study of laparoscopic procedures from the United Kingdom reported a case-fatality rate of 10 per 100,000 procedures (Chamberlain and Brown, 1978). The case-fatality rate of tubal sterilization in U.S. hospitals has been estimated to be approximately 4 per 100,000 procedures (Peterson et al., 1982a). In a report from India the case-fatality rate from postpartum tubal sterilization was 7 per 100,000 procedures (Indian Council of Medical Research, 1982). In two studies from Bangladesh the case-fatality rate was estimated to be between 12 and 19 per 100,000 procedures (Grimes et al., 1982a, 1982b).

Worldwide, most sterilization-attributable deaths are caused by complications related to use of anesthesia, although deaths have occurred from hemorrhage and thermal injury (Peterson et al., 1983). In the United States 11 of 29 women whose deaths were attributable to sterilization suffered complications of general anesthesia (Peterson et al., 1983). Other reports from the United Kingdom and France have also identified complications of general anesthesia as the leading cause of laparoscopic-associated, sterilization-attributable death (Mintz, 1977; Chamberlain and Brown, 1978). Even in countries where general anesthesia is not often used, complications of anesthesia are still a major cause of sterilization-attributable death (Grimes et al., 1982a; Ross et al., 1985).

Reports regarding nonfatal complications attributable to tubal sterilization have varied by study design, definition, and classification of complications. Although comparing complication rates between studies is difficult, such studies indicate that major morbidity associated with tubal sterilization is uncommon and that safety varies with surgical and anesthetic technique. One large multicenter study, which included data from 23 countries, reported a complication rate of 2.0 percent for the approximately 7,000 women undergoing laparoscopy with silastic band application (Mumford et al., 1980). This rate was approximately twice that experienced by the approximately 5,000 women undergoing minilaparotomy procedures (0.8 percent). The WHO has reported the only randomized multicenter, multinational study. In that study approximately 800 women had minilaparotomies, and approximately 800 underwent laparoscopy using electrocoagulation. Major complications occurred in 1.5 percent of women undergoing minilaparotomy and in 0.9 percent of women undergoing laparoscopy. Minor complications were reported in 11.6 percent and 6.0 percent, respectively (WHO, 1982a).

The WHO also reported on a multicenter study of postpartum sterilization in which major complications occurred in only 0.3 percent of the patients (WHO, 1982b). This rate is identical to that reported from a large multicenter study of postpartum minilaparotomy conducted in India (Indian Council of Medical Research, 1982). In that study major complication rates associated with minilaparotomy did not substantially vary between those minilaparotomy procedures performed postpartum, those performed in association with early pregnancy termination, or those performed as an interval procedure. By contrast, women undergoing interval laparoscopy had a complication rate of 1.2 percent, and women undergoing interval colpotomy (via a vaginal incision) had an overall complication rate of 5.7 percent.

In a U.S. multicenter prospective study of laparoscopic tubal sterilization, 1.7 percent of women experienced at least one of six standard intra-operative or postoperative complications (DeStefano et al., 1983a). The most frequent major complication (1.1 percent) was unintended major surgery. In some instances this unintended surgery occurred because of incidental pathology identified during laparoscopy or because of technical limitations of laparoscopy itself. Thus, not all complications were directly caused by the laparoscopic procedure per se. The risk of complications was increased twofold or more by the following factors: obesity, lung disease, diabetes mellitus, previous abdominal or pelvic surgery, and a history of PID.

Although the overall major complication rate attributable to tubal sterilization is less than 2 percent, such complications can result in serious injury or death. The likelihood of serious injury appears to vary somewhat by surgical approach and tubal occlusion technique. Most minilaparotomy complications are not serious, with minor hemorrhage, minor wound infections, and uterine perforations reported most frequently (Liskin et al., 1985). By contrast, laparoscopy is more likely to result in serious complications. While rare, perforation injuries to major blood vessels or the gastrointestinal tract can occur (Peterson et al., 1982b). Open laparoscopy should markedly reduce the risk of these complications. One comparative study assessing complications among 1,112 women undergoing open laparoscopy and 288 women undergoing conventional laparoscopy failed to demonstrate a difference in complication rates (Bhiwandiwala et al., 1985). However, to detect a difference between open and closed laparoscopy, an epidemiologic study would have to involve thousands of women to have sufficient study power to detect a difference.

Complication rates also may vary with respect to method of tubal occlusion. For example, mesosalpingeal hemorrhage occurs more often from silastic band application than from alternative techniques. Unipolar coagulation increases the risk of thermal bowel injury. Although this type of injury likely occurs in fewer than 1 per 1,000 cases, more than 100 nonfatal thermal bowel injuries and 3 deaths from the use of unipolar instruments have been reported in the United States (Peterson et al., 1981a).

Because of the number of women involved, any important long-term sequelae of tubal sterilization would have major impact. On balance, the existing literature has failed to demonstrate any important negative long-term health effects of tubal sterilization. Most concerns regarding potential long-term sequelae have dealt with four issues: (1) menstrual abnormalities, (2) hysterectomy following tubal sterilization, (3) regret, and (4) ectopic pregnancy. We addressed the last concern previously in the section on sterilization efficacy.

Before 1980 most studies found an increase in menstrual abnormalities following tubal sterilization, the so-called post-tubal syndrome. Such studies, however, had major methodological limitations, including: (1) failure to identify and account for biases inherent in their retrospective design, (2) failure to use comparison groups, (3) failure to consider the effects of prior contraceptive use, (4) failure to consider women without menstrual changes or with improvements in menstrual symptoms, and (5) failure to evaluate information regarding presterilization menstrual patterns. Since 1980 most reports have had fewer methodological limitations and have failed to support the existence of a post-tubal syndrome.

One study has reported data from a series of approximately 10,000 women undergoing tubal sterilization at 64 institutions in 27 countries (Bhiwandiwala et al., 1983). Six menstrual symptoms were evaluated before and after sterilization, with most women reporting no changes 1 year after sterilization. When menstrual changes did occur, about as many women experienced improvement in symptoms as experienced deleterious change. A substantial percentage of the observed changes were attributable to cessation of OC or IUD use rather than to the sterilization procedure per se. No significant differences in menstrual patterns after sterilization were found among the various tubal occlusion techniques reviewed.

Another report concerned a sample of approximately 1,500 women selected from 45 centers in 24 countries (Fortney et al., 1983). The most important determinants of menstrual patterns after sterilization were the patterns at the time of sterilization. Women with abnormal patterns before sterilization were three times more likely to experience change than women with normal cycles; many of these women experienced change toward more normal cycles.

Several other reports from the United States and the United Kingdom that assessed menstrual patterns 1 or 2 years after sterilization failed to find support for the existence of a post-tubal syndrome. In the United States the Centers for Disease Control used data from a multicenter prospective study in which approximately 2,500 women were followed for 2 years after sterilization (DeStefano et al., 1983b). Each woman served as her own control; her menstrual function at the follow-up interview was compared with her menstrual function at the preoperative interview. Except for menstrual pain among women who underwent unipolar electrocoagulation, the prevalence of adverse menstrual function after tubal sterilization did not increase. Further, approximately 50 percent of women with adverse menstrual function preoperatively had an improvement by 2 years after tubal sterilization.

In a report from England 551 women undergoing interval sterilization were studied (Foulkes and Chamberlain, 1985). No increase in menstrual abnormalities among sterilized women compared with nonsterilized women was found after a year of follow-up. Both sterilized and nonsterilized women were more likely to experience heavy and prolonged menstrual bleeding if they had been using OCs before sterilization. Thus, discontinuation of OCs was more likely to result in abnormalities of menstruation than was sterilization per se.

Two studies, one from the United Kingdom (Vessey et al., 1983) and one from the United States (DeStefano et al., 1985), reported on menstrual function among women more than 2 years after their sterilizations. The study from the United Kingdom compared the experience of 2,243 women undergoing tubal sterilization with 3,551 women whose husbands underwent vasectomy. Three years after sterilization hospital referral or hospitalization for menstrual complaints was nearly equal for women undergoing sterilization and for the comparison group. After 6 years, sterilized women had a slight, but not statistically significant, increased risk for hospital referral or admission for menstrual complaints.

The study from the United States was principally designed to assess the long-term impact of OC use (DeStefano et al., 1985). In that analysis 719 women who underwent tubal sterilization were compared with 1,083 women whose partners underwent vasectomy. At follow-up, with intervals longer than 2 years, the tubal sterilization group had a significantly increased risk of abnormal menstrual cycles and combinations of two or more adverse menstrual outcomes. The likelihood of menstrual abnormalities was greatest, however, among the group of sterilized women who had presterilization menstrual complaints.

To date, no study has been reported that includes long-term follow-up for sterilized and nonsterilized women in a manner that allows comparison of specific menstrual symptoms and specific methods of tubal occlusion. The Centers for Disease Control in the United States is conducting such a study, but it will not be completed until the early 1990s.

Whether tubal sterilization increases the risk of subsequent hysterectomy is uncertain. Concerns that it does have been based, in part, on the possible existence of the post-tubal syndrome we noted earlier. Whether or not a post-tubal syndrome exists, the perception that it does may increase the likelihood that menstrual abnormalities after sterilization are managed surgically. Further, once a woman has been sterilized, either she or her physician may resort more quickly to surgical management of any gynecologic problem. These possibilities were assessed in the previously mentioned cohort study from the United Kingdom (Vessey et al., 1983). After both 3 years and 6 years of follow-up, hospital referrals leading to hysterectomy were equally likely in women who had undergone tubal sterilization and in wives of men who had undergone vasectomy. In Canada a population-based study using data from a health insurance plan studied 4,374 women aged 25 to 44 who underwent tubal ligation in 1974 (Cohen, 1987). As a comparison group, a random sample of 10,000 women registered in the insurance plan in 1974 was chosen. After 2 years of follow-up, no difference was found in adverse gynecologic outcomes between the two groups. However, beginning with the 2-year follow-up and increasing for up to 9 years, women ages 25 to 29 undergoing tubal sterilization had a statistically significant 60 percent increase in the probability of subsequent hysterectomy, even after controlling for other risk factors. For women aged 30 and over, tubal sterilization did not increase the likelihood of subsequent hysterectomy. The results from the two cohort studies with longer-term follow-up argue for continuing surveillance of sterilization sequelae beyond a 1-or 2-year period.

Published reports indicate that most women are satisfied with their decision to undergo sterilization. An overview of recent worldwide studies indicates that 2 percent to 13 percent of women interviewed 6 months to 6 years postoperatively expressed regret at having been sterilized; only 1 percent to 3 percent of those women seriously considered or underwent sterilization reversal procedures (Liskin et al., 1985). However, the prevalence of regret is likely to vary substantially by definition of regret. One survey of U.S. women found that 26 percent responded affirmatively when asked, ''If it were possible for you to have another baby, would you, yourself, like to have one?'' (Henshaw and Singh, 1986). In that same survey 10 percent of women responded affirmatively when asked, "As things look to you just now, if the operation could be safely reversed, that is changed back, would you want to have it reversed?"

Careful presterilization counseling is likely to minimize the chance of poststerilization regret. To maximize effectiveness, such counseling should focus on the reasons women might regret having been sterilized. A variety of studies have indicated that younger women, usually reported as less than 30 years of age, are more likely to regret having been sterilized (Grubb et al., 1985). In many developed countries divorce and remarriage are common reasons women regret sterilization and request its reversal.

A multicenter prospective study conducted by the Centers for Disease Control in the United States has found that only 2 percent of women regretted having a tubal sterilization I year after the procedure, compared with 2.7 percent after 2 years (Grubb et al., 1985). Five years after the procedure approximately 4 percent regretted it (unpublished data). Because the possibility for major life changes (e.g., death of a spouse or child) increases as women age, the longer the time since the procedure, the more likely women may be to regret having been sterilized. Thus, length of follow-up must be considered when comparing rates of regret in various studies.

In another study conducted in the United States, Shain et al. (1986) compared the likelihood that women undergoing tubal sterilization will regret it relative to the likelihood that women whose husbands underwent vasectomy will have regrets. At 1-year follow-up, only 2 of 234 (0.9 percent) women who had undergone tubal ligation compared with 2 of 154 (1.3 percent) women whose husbands underwent vasectomy expressed regret at having had the procedure. As the authors indicated, however, dissatisfaction with sterilization may involve various degrees of intensity, ranging from occasional concerns to desire for reversal. Further, these feelings are not static. When the authors used a broader measure of satisfaction/dissatisfaction as an outcome, women who had undergone tubal sterilization expressed significantly more positive feelings during follow-up interviews than did women whose husbands underwent vasectomies. This was attributed to a disproportionate prevalence of female control over reproductive decision making among women undergoing tubal sterilization. The authors concluded that counseling of the couple and the ability to exercise control over one's body are important predictors of sterilization regret.

Sterilization Reversal

The proportion of sterilized women who seek reversal is small but nontrivial (Ross et al., 1985). Highly sophisticated microsurgical techniques for tubal reanastomosis that increase the likelihood of successful reversal have been developed. These techniques are generally limited to developed countries. When available, such procedures are expensive and require laparotomy under general anesthesia. The likelihood of successful reversal depends on the method of tubal occlusion originally used. In general, 50 percent to 70 percent of women undergoing reversal surgery achieve intrauterine pregnancy (Liskin et al., 1985). However, most reports are from the selected series of highly skilled surgeons using sophisticated microsurgical techniques.

Vasectomy is cutting and occluding the vas deferens to prevent sperm transport in semen. Although generally considered to be safe, simple, and highly effective, vasectomy is not widely popular in most of the world. In fact, the majority of the estimated 41 million men currently using vasectomy for contraception reside in four countries—the United States, United Kingdom, China, and India (Gallen et al., 1986). By comparison, more than 95 million women worldwide have undergone tubal sterilization. Among regions, Africa is the least active in providing vasectomy services, Asia the most active, and Latin America moderately active (Ross and Huber, 1983). The limited popularity of vasectomy has been attributed to motivational factors and access to services (Gallen et al., 1986). In addition, female sterilization has become more popular than male sterilization in some countries (Ross and Huber, 1983).

Vasectomy is a minor surgical procedure that usually takes 5 to 10 minutes to perform (Ross et al., 1985). The procedure consists of isolating the vas deferens and then using one of three methods to occlude it: ligation, coagulation, or clip application. Ligation is the most widely used approach. If ligatures are tied too snugly, resulting in vas transection, or too loosely, resulting in incomplete occlusion, sperm can leak into surrounding tissues, resulting in sperm granuloma formation. Coagulation of the vas mucosa is an alternative method of occlusion that minimizes damage to the vas muscularis. Some believe that this method reduces the likelihood of sperm granuloma formation. Clips are rarely used for vas occlusion. Several clips must be applied to achieve maximum effectiveness, and, because they are not absorbable, the vasectomized man can sometimes feel the clips.

Local anesthesia without premedication is the anesthetic technique of choice for most vasectomies (Association for Voluntary Sterilization, 1983). The strong preference for local anesthesia is based on the higher risk of morbidity and mortality associated with general anesthesia (Peterson et al., 1981b, 1983). A survey of selected outpatient facilities conducted in the United States in 1980 indicated that the type of anesthesia used varied substantially by facility type (Kendrick et al., 1985). Freestanding surgical facilities reported performing 29 percent of their vasectomies using general anesthesia; conversely, 96 percent of the facilities not classified as freestanding reported using local or regional anesthesia. Outside the United States, particularly in developing countries, almost all vasectomies are performed using local anesthesia (Ross et al., 1985).

Vasectomy failure rates have ranged from 0 percent to 2.2 percent, with most studies reporting fewer than I percent (Liskin et al., 1983) ( Table 2 ). However, few data are available that allow for a comparative assessment of failure rates associated with the various methods of vas occlusion. Most vasectomy failures can be attributed to unprotected coitus shortly after vasectomy or spontaneous reanastomosis of the vas. Unprotected coitus before sperm has been cleared from the male reproductive tract can result in pregnancy, although the duration of male fertility following vas occlusion remains uncertain (Lewis et al., 1984). Sperm may be absent within I to 10 weeks or more after vasectomy, depending in part on the frequency of ejaculation (Liskin et al., 1983). The Association for Voluntary Sterilization recommends using contraceptives for the first 15 ejaculations or 6 weeks after vasectomy (Ross et al., 1985).

Most true vasectomy failures occur when fistulous tracks develop through a sperm granuloma, resulting in a spontaneous reanastomosis of the vas (Liskin et al., 1983). The reanastomosis usually occurs within several months after vasectomy, although late reanastomosis up to 3 years after vasectomy has been documented, both after ligation and coagulation methods. In a study of 14,047 men the wives of 6 men became pregnant between 16 months and 3 years after vasectomy (Philp et al., 1984). Other causes of vasectomy failure include operating on the wrong structure and congenital duplication of the vas (Liskin et al., 1983).

The risk of death attributable to vasectomy is quite low. A detailed review of sterilization-attributable deaths in Bangladesh occurring in 1979 and 1980 identified seven deaths attributable to vasectomy, for a vasectomy-attributable mortality rate of 31 per 100,000 procedures (Grimes et al., 1982a). Scrotal infection and sepsis caused most of the deaths. Subsequently, the use of sterile gloves during all vasectomies was recommended. Follow-up surveillance in 1981 identified no vasectomy-attributable deaths among approximately 14,000 men (Grimes et al., 1982b). The Association for Voluntary Sterilization has recorded only two vasectomy-attributable deaths associated with more than 160,000 procedures performed in the international programs it has supported (Ross et al., 1985). Vasectomy-attributable deaths in the United States are quite rare. While there has been no systematic effort to identify such deaths in the United States, at least one vasectomy-attributable death is known to have occurred (District Court of Appeals of Florida, Dunn v. Campbell, 1964).

The most common complications of vasectomy are swelling of the scrotal tissue, bruising, and pain. As many as 50 percent of men undergoing the procedure may experience these complaints, which generally subside within I to 2 weeks without treatment (Liskin et al., 1983). Hematoma formation and infection, which can be serious but generally are not, occur much less frequently.

Hematoma formation generally occurs in fewer than I percent of vasectomized men, but it has been reported in as many as 4 percent. Physicians surveyed in the United States in 1983 reported a hematoma rate of 2 percent (Kendrick et al., 1987). In that survey the hematoma rate was significantly higher among physicians performing I to 10 vasectomies per year (4.6 percent) than among those performing 11 to 50 vasectomies (2.4 percent) or more than 50 vasectomies (1.6 percent).

Infection after vasectomy is uncommon, usually occurring in fewer than 2 percent of men, although rates of infection as high as 6 percent have been reported (Liskin et al., 1983). Most infections occur at the site of skin incisions or around skin sutures. In rare instances, such as those reported in Bangladesh, infection can result in sepsis and death (Grimes et al., 1982a). Careful aseptic technique and sterile gloves are likely to reduce the risk of infection (Association for Voluntary Sterilization, 1983).

Epididymitis, manifested as swelling and tenderness of the epididymis, is generally reported in fewer than I percent of men undergoing vasectomy (Liskin et al., 1983). This complication has been attributed to a hydrostatic pressure increase within the epididymis after vas occlusion (Association for Voluntary Sterilization, 1983). Bacterial infection as an etiology of the epididymitis is uncommon (Schmidt, 1975). Epididymitis may develop several months after vasectomy, but it is most likely to occur soon after the procedure. Symptoms usually subside within a week (Ross et al., 1985). One report (Massey et al., 1984) compared vasectomized and nonvasectomized men with respect to the likelihood of developing epididymitis. After vasectomy, 2.6 percent of men experienced epididymitis versus 1.1 percent of men who had not had the procedure. However, differences between the two groups in the rate of epididymitis occurred only within the first year after vasectomy.

Sperm granulomas—nodules containing sperm, epithelial cells, and lymphocytes—represent an inflammatory response to sperm leaking into surrounding tissue. Most such granulomas are small and clinically not important, but they can result in pain at the site of vas occlusion or in the epididymis. The incidence of sperm granulomas is not known. However, granulomas at the vasectomy site have been found in 15 percent to 40 percent of sterilization reversal procedures; granulomas in the epididymis have been found in 10 percent to 50 percent of these procedures (Liskin et al., 1983). Symptomatic sperm granulomas are substantially less frequent. Follow-up studies report symptomatic granulomas in only 0 percent to 3 percent of vasectomies (Ross et al., 1985). In such instances a tender nodule at the site of vas occlusion or in the epididymis may cause discomfort, although the discomfort usually subsides spontaneously (Schmidt and Morris, 1973). As already noted, sperm granulomas can cause vasectomy failure if fistulous tracks develop through the granuloma. Ligation for vas occlusion is more likely to result in sperm granuloma formation than use of coagulation (Schmidt and Free, 1978). However, coagulation results in more complete occlusion of the vas, and this occlusion may increase the likelihood of an epididymal granuloma with resultant epididymal obstruction (Silber, 1978).

Long-Term Safety

A series of major epidemiologic investigations have been conducted in the 1980s to assess the long-term safety of vasectomy. In general, those studies are remarkably consistent in failing to identify any long-term health risks attributable to vasectomy.

Studies of long-term complications associated with vasectomy were stimulated primarily by two concerns: (1) evidence that 50 percent to 70 percent of men develop antisperm antibodies following vasectomy (Ansbacher, 1971; Schulman et al., 1972) and (2) reports of increased atherosclerosis in cynomolgus monkeys after vasectomy compared with nonvasectomized monkeys (Alexander et al., 1974). These findings are the basis for the hypothesis that antisperm antibodies form circulating immune complexes that might collect in arterial walls and contribute to the development of atherosclerosis (Alexander and Anderson, 1979). At least six epidemiologic studies specifically designed to assess this hypothesis have since indicated that vasectomy does not increase the incidence of MI in the 10 years following vasectomy (Goldacre et al., 1978, 1979; Walker et al., 1981; Petitti et al., 1982; Massey et al., 1984; Perrin et al., 1984). Subsequent to these reports, Rosenberg et al. (1986) evaluated data from a hospital-based, case-control study to assess whether vasectomy was associated with a subsequent increase in the risk of MI 10 or more years after surgery and whether any effect was more pronounced in men already predisposed to MI. The analysis supported findings from previous reports indicating that vasectomy did not increase the risk of MI within 10 years after surgery. Further, the authors found no overall increase in risk 10 or more years after surgery and no additional risk among men already predisposed to MI because of the presence of other risk factors for coronary artery disease. In summary, the available epidemiologic studies provide strong evidence that vasectomy does not increase the likelihood of MI.

As noted, much of the concern regarding the relationship between vasectomy and atherosclerosis was precipitated by reports of worsening atherosclerosis among vasectomized monkeys. Recently, the investigators who first reported this finding have presented data that do not support their first report. Their new data suggest that vasectomy does not increase the extent of atherosclerosis among cynomolgus monkeys, even in those found to be hyperresponsive to an atherogenic diet (Clarkson et al., 1988).

Several epidemiologic studies have assessed the relationship between vasectomy and a variety of other diseases associated with alterations of the immune system. In a historical cohort study conducted in the United States, 10,590 vasectomized men from four cities were interviewed, along with a neighborhood control for each vasectomized man (Massey et al., 1984). Any report of disease potentially related to vasectomy via an immunopathologic mechanism was validated by medical record review. Except for epididymitis/orchitis, the incidence of diseases, including those with a known or suspected immunopathologic basis, was similar for vasectomized men and paired controls. This finding was true not only for individual diseases but also for broader categories of diseases in which immunopathologic mechanisms might operate. Two other studies have failed to show an increase in the incidence of hospitalized illness for vasectomized men compared with nonvasectomized men (Walker et al., 1981; Petitti et al., 1982). The sole exception was that in one of the studies vasectomized men had higher rates of hospitalization for diseases of the genito-urinary system during the early postvasectomy period (Walker et al., 1981).

One recent report (Kronmal et al., 1988) raises additional concern regarding the relationship between vasectomy and subsequent genito-urinary tract disease by suggesting that vasectomy may increase the likelihood of urolithiasis. The age-adjusted relative risk for calculi among men who had undergone vasectomy was statistically significantly increased by approximately 70 percent. Although based on a study designed to evaluate the relationship between vasectomy and coronary artery disease, these findings are supported by another report mentioned previously (Walker et al., 1981). By contrast, another study found that the incidence of hospitalization for genito-urinary diseases was not significantly different between vasectomized and nonvasectomized men (Petitti et al., 1983). One possible biologic explanation for a relationship between vasectomy and urolithiasis centers around the production of antisperm antibodies. Whether antibody production might increase the tendency for formation of urinary calculi is not known. The possibility that vasectomized men may have an increased risk for genito-urinary disease warrants further evaluation, but available data are generally reassuring.

Vasectomy Reversal

Changes in life situation may lead men to regret their decision to undergo vasectomy. Surveys indicate that the prevalence of such regret worldwide is low (Liskin et al., 1983). Vasectomy reversal requires a high level of surgical expertise, is expensive, and is relatively unavailable in many parts of the world. Microsurgical techniques are necessary for optimal results. Furthermore, the original vasectomy technique may affect the likelihood of success of any subsequent reversal attempt. Because of the wide variety of factors influencing the likelihood of successful reversal, the success rate in the aggregate is difficult to estimate. Most surgeons report 30 percent to 60 percent success rates for vasectomy reversal, whereas some report even higher rates (Liskin et al., 1983). Even if the theoretical reversal rate remains consistently high, the technical difficulty of the surgery, with the attendant requirements for skilled microsurgeons, makes reversal impractical or unavailable for men in much of the world (Ross et al., 1985).

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• World Health Organization Task Force on Female Sterilization. 1982. b. Randomized comparative study of culdoscopy and minilaparotomy for surgical contraception in women . Contraception 26:587–593. [ PubMed : 6762946 ]
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Nancy C. Lee and Herbert B. Peterson are deputy chief and chief, respectively, of the Epidemiologic Studies Branch, Division of Reproductive Health, Center for Chronic Disease Prevention and Health Promotion of the Centers for Disease Control. Susan Y. Chu is epidemiologist in the Special Projects Section, Surveillance Branch, AIDS Program, Center for Infectious Diseases, of the Centers for Disease Control.

• Cite this Page National Research Council (US) Committee on Population; Parnell AM, editor. Contraceptive Use and Controlled Fertility: Health Issues for Women and Children Background Papers. Washington (DC): National Academies Press (US); 1989. Health Effects of Contraception.
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Birth Control

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3 OTC Birth Control: Revolutionizing Access for Women’s Health

Executive Summary Contraception is effective in improving health and well-being in women while reducing health care costs from unintended pregnancies and abortion. Women’s access to birth control is inadequate, and oral contraception should be available over the counter in Kentucky. Introduction Contraception is recognized by the Centers for Disease Control and Prevention as one of […]

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4 Navigating the Intricacies of Birth Control: Unveiling its Impact on Cardiovascular Health

Abstract: Oral Contraceptives (OC) and Birth control pills can cause a lot of side effects in the human body. Taking birth control pills increases the risk of having a stroke or heart attack. Based on the case report, a woman entered the hospital with unknown causes of how she was having artery blocking. That woman […]

• Introduction
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This algorithm has not been validated for clinical use. IUD indicates intrauterine device; PATH, Pregnancy Attitudes, Timing, and How important is pregnancy prevention.

This algorithm has not been validated for clinical use. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); MEC, Medical Eligibility Criteria for Contraceptive Use.

• Selection, Effectiveness, and Adverse Effects of Contraception—Reply JAMA Comment & Response April 19, 2022 Stephanie Teal, MD, MPH; Alison Edelman, MD, MPH
• Selection, Effectiveness, and Adverse Effects of Contraception JAMA Comment & Response April 19, 2022 Ekaterina Skaritanov, BS; Gianna Wilkie, MD; Lara C. Kovell, MD
• Contraception in Women With Cardiovascular Disease JAMA JAMA Insights August 9, 2022 This JAMA Insights in Women’s Health series summarizes the prevalence of cardiovascular disease among women of childbearing age, the most effective forms of contraception based on the patient’s medical condition and preference, and the risks and adverse effects associated with contraindicated forms of contraception. Kathryn J. Lindley, MD; Stephanie B. Teal, MD, MPH
• Patient Information: Long-Acting Reversible Contraception JAMA JAMA Patient Page October 4, 2022 This JAMA Patient Page describes types of long-acting reversible contraception, how they are placed and removed, and their potential side effects. Elisabeth L. Stark, MD; Aileen M. Gariepy, MD, MPH, MHS; Moeun Son, MD, MSCI
• Patient Information: Medication Abortion JAMA JAMA Patient Page November 1, 2022 This JAMA Patient Page describes medication abortion and its risks and effectiveness. Rebecca H. Cohen, MD, MPH; Stephanie B. Teal, MD, MPH

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Teal S , Edelman A. Contraception Selection, Effectiveness, and Adverse Effects : A Review . JAMA. 2021;326(24):2507–2518. doi:10.1001/jama.2021.21392

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Contraception Selection, Effectiveness, and Adverse Effects : A Review

• 1 Department of OB/GYN, University Hospitals Medical Center and Case Western Reserve University, Cleveland, Ohio
• 2 Department of OB/GYN, Oregon Health & Science University, Portland
• Comment & Response Selection, Effectiveness, and Adverse Effects of Contraception—Reply Stephanie Teal, MD, MPH; Alison Edelman, MD, MPH JAMA
• Comment & Response Selection, Effectiveness, and Adverse Effects of Contraception Ekaterina Skaritanov, BS; Gianna Wilkie, MD; Lara C. Kovell, MD JAMA
• JAMA Insights Contraception in Women With Cardiovascular Disease Kathryn J. Lindley, MD; Stephanie B. Teal, MD, MPH JAMA
• JAMA Patient Page Patient Information: Long-Acting Reversible Contraception Elisabeth L. Stark, MD; Aileen M. Gariepy, MD, MPH, MHS; Moeun Son, MD, MSCI JAMA
• JAMA Patient Page Patient Information: Medication Abortion Rebecca H. Cohen, MD, MPH; Stephanie B. Teal, MD, MPH JAMA

Importance   Many women spend a substantial proportion of their lives preventing or planning for pregnancy, and approximately 87% of US women use contraception during their lifetime.

Observations   Contraceptive effectiveness is determined by a combination of drug or device efficacy, individual fecundability, coital frequency, and user adherence and continuation. In the US, oral contraceptive pills are the most commonly used reversible method of contraception and comprise 21.9% of all contraception in current use. Pregnancy rates of women using oral contraceptives are 4% to 7% per year. Use of long-acting methods, such as intrauterine devices and subdermal implants, has increased substantially, from 6% of all contraceptive users in 2008 to 17.8% in 2016; these methods have failure rates of less than 1% per year. Estrogen-containing methods, such as combined oral contraceptive pills, increase the risk of venous thrombosis from 2 to 10 venous thrombotic events per 10 000 women-years to 7 to 10 venous thrombotic events per 10 000 women-years, whereas progestin-only and nonhormonal methods, such as implants and condoms, are associated with rare serious risks. Hormonal contraceptives can improve medical conditions associated with hormonal changes related to the menstrual cycle, such as acne, endometriosis, and premenstrual dysphoric disorder. Optimal contraceptive selection requires patient and clinician discussion of the patient’s tolerance for risk of pregnancy, menstrual bleeding changes, other risks, and personal values and preferences.

Conclusions and Relevance   Oral contraceptive pills are the most commonly used reversible contraceptives, intrauterine devices and subdermal implants have the highest effectiveness, and progestin-only and nonhormonal methods have the lowest risks. Optimal contraceptive selection incorporates patient values and preferences.

Contraception is defined as an intervention that reduces the chance of pregnancy after sexual intercourse. According to a report from 2013, an estimated 99% of women who have ever had sexual intercourse used at least 1 contraceptive method in their lifetime. 1 Approximately 88% of sexually active women not seeking pregnancy report using contraception at any given time. 2 All nonbarrier contraceptive methods require a prescription or initiation by a clinician. Therefore, contraception is a common reason women 15 to 50 years of age seek health care. 3 This review summarizes current evidence regarding efficacy, adverse effects, and optimal selection of reversible contraceptives. This review uses the terms women and men when the biological expectation for the individual is ovulation or sperm production, respectively.

A search of OVID Medline All, Embase.com, and Ovid Evidence-Based Medicine Reviews–Cochrane Central Register of Controlled Trials for English-language studies was conducted for articles published between January 1, 2000, and June 28, 2021, to identify randomized clinical trials, systematic reviews, and practice guidelines related to contraception or contraceptives. After excluding duplicates and articles not relevant to this review, 2188 articles were identified as potentially relevant via title or abstract content. Thirty-seven articles, consisting of 13 randomized clinical trials, 22 systematic reviews, and 2 guidelines were included. Evidence-based guidelines that used GRADE and systematic reviews were selected for inclusion over individual studies. Clinical practice guidelines from the Society of Family Planning, the World Health Organization, and the American College of Obstetricians and Gynecologists on selected topic areas were reviewed to identify additional key evidence.

The mean age of first sexual intercourse among females in the US is 17 years. 4 Many women typically use contraceptives for approximately 3 decades. 2 The choice of contraceptive is determined by patient preferences, tolerance for contraceptive failure, and adverse effects. Clinicians should elicit patient preferences, identify possible contraindications to specific contraceptives, and facilitate contraceptive initiation and continuation. Clinicians should also be prepared to address misperceptions ( Box ). Some experts recommend screening for contraceptive need at each visit. Two validated screening options, with toolkits available online, are One Key Question and the PATH questions (Pregnancy Attitudes, Timing, and How important is pregnancy prevention). 5 , 6

Commonly Asked Questions About Contraception

What options are available for male contraception? There are currently no Food and Drug Administration–approved contraceptive options for men except condoms. Current male contraceptive methods under evaluation attempt to suppress sperm count to <1 million/mL and include a testosterone plus progestin topical gel.

Are contraceptives associated with increased rates of cancer? Combined hormonal contraceptives, such as combined oral contraceptive pills, protect against endometrial and ovarian cancer. They are associated with an increased risk of early breast cancer diagnosis in current or recent users (ie, within the past 6 mo). The incidence is 68 cases per 100 000 person-years compared with 55 cases per 100 000 nonuser-years. There are no associations of past contraceptive use with increased rates of cancer and there is no association of past contraceptive use and mortality.

Can teenagers use intrauterine devices (IUDs)? Prior guidance suggested restricted use of IUDs by teenagers, nonmonogamous or unmarried, and nulliparous women, but there is no high-quality evidence to support this recommendation. None of these characteristics are true contraindications.

Should all women use the most effective form of contraception? The choice of contraceptive is determined by patient preferences and tolerance for failure. Patients may value other attributes of a method (such as route of administration or bleeding patterns) more highly than effectiveness, and may prefer to have a slightly higher risk of unplanned pregnancy to avoid other adverse effects.

Is the pill as effective for individuals with obesity? Obesity adversely influences contraceptive steroid levels but determining whether this affects contraceptive effectiveness is difficult. The primary reason for contraceptive failure is suboptimal adherence. The use of any method for individuals no matter their weight will prevent more pregnancies than not using a method.

Why are pills not available over the counter (OTC)? Combined hormonal contraceptives are unlikely to be available OTC in the US due to concerns regarding increased rates of thrombosis. Efforts to bring progestin-only pills OTC are progressing.

Quiz Ref ID Reversible contraceptive methods are typically grouped as hormonal (such as progestin-only pills or estrogen-progestin patches) or nonhormonal (condoms, diaphragms) and long-acting (such as intrauterine devices [IUDs]) or short-acting (such as pills). Reversible contraceptive methods can also be grouped by level of effectiveness for pregnancy prevention. Except for behavioral methods, condoms, and spermicide, contraceptive methods are only available by prescription in the US.

Progestins and estrogens are steroid or lipid hormones. Hormonal contraception contains a progestin with or without an estrogen. Progesterone is the only naturally occurring progestin; most contraceptive progestins, such as levonorgestrel and norethindrone, are synthesized from testosterone. Progestins provide a contraceptive effect by suppressing gonadotropin-releasing hormone from the hypothalamus, which lowers luteinizing hormone from the pituitary, which in turn prevents ovulation. 7 , 8 In addition, progestins have direct negative effects on cervical mucus permeability. Progestins reduce endometrial receptivity and sperm survival and transport to the fallopian tube. 9 - 11 Estrogens enhance contraceptive effectiveness by suppressing gonadotropins and follicle-stimulating hormone, preventing the development of a dominant follicle. However, the most important contribution of estrogens to progestin-based contraceptives is the reduction of irregular bleeding. The estrogen component in most combined hormonal contraceptives is ethinylestradiol.

A variety of progestin-only contraceptive methods exists ( Table 1 ). Their effectiveness varies based on dose, potency, and half-life of the progestin as well as user-dependent factors, such as adherence to the prescription schedule. 12 , 13

Progestin-only pills include norethindrone- and drospirenone-containing formulations, which differ in their ability to suppress ovulation. Norethindrone pills contain 300 µg of norethindrone compared with 1000 µg in a typical combined contraceptive pill. The lower amount of progestin in norethindrone pills results in less consistent ovulation suppression and more potential for breakthrough bleeding. The contraceptive efficacy is maintained by other progestin-mediated effects. Drospirenone-only pills contain slightly more progestin than an estrogen and progestin combined hormonal contraception, which aids in ovulation suppression. In one study in which participants delayed their drospirenone-containing pill intake by 24 hours, mimicking a missed dose, ovulation suppression was maintained with only 1 participant of 127 having evidence of ovulation. 14 The benefits of progestin-only contraceptive pills include ease of initiation and discontinuation, fertility return within 1 cycle, safety profile, and minimal effect on hemostatic parameters. 15

Quiz Ref ID Depot medroxyprogesterone acetate (DMPA) is an injectable progestin available in intramuscular (150 mg) and subcutaneous (104 mg) formulations, which are administered at 12- to 14-week intervals. While DMPA is associated with irregular uterine bleeding, this pattern improves with longer duration of use. A systematic review of DMPA-related bleeding patterns (13 studies with 1610 patients using DMPA) found that 46% of those using DMPA were amenorrheic in the 90 days following the fourth dose. 16 DMPA is the only contraceptive method that can delay return to fertility. The contraceptive effect and cycle irregularity can persist for up to 12 months after the last dose, 17 likely due to persistence in adipose tissue and its effectiveness in suppressing the hypothalamic-pituitary-ovarian (HPO) axis. DMPA may be best suited for those who benefit from amenorrhea (eg, patients with developmental disabilities, bleeding diatheses) but not by those who want to conceive quickly after discontinuation. Typical effectiveness of DMPA and progestin-only contraceptive pills is 4 to 7 pregnancies per 100 women in a year. 12 , 18

Quiz Ref ID Progestin-only long-acting methods, such as the levonorgestrel (LNG) IUD and the subdermal implant, have typical effectiveness rates of less than 1 pregnancy per 100 women per year similar to permanent methods, such as tubal ligation or vasectomy ( Table 2 ). 12 , 18 These methods are also associated with return to fertility within 1 cycle after discontinuation. The LNG IUD maintains efficacy for at least 7 years, with amenorrhea rates of up to 20% at 12 months and 40% at 24 months. 19 However, initiation requires an in-person visit with a clinician trained in IUD placement. The etonogestrel subdermal implant is effective for up to 5 years 20 and is easily placed or removed. Initiation and discontinuation also require in-person visits. The bleeding profile of the implant is less predictable and up to 11% of users remove it in the first year due to irregular bleeding. 21 An analysis of 11 studies (923 participants) from Europe, Asia, South America, and the US found that the bleeding pattern in the first 3 months (such as prolonged, frequent, or irregular episodes) is consistent with future bleeding patterns. 21 However, those with frequent or prolonged bleeding in the first 3 months have a 50% chance of improvement in the subsequent 3 months. 21

Combined hormonal methods that contain both estrogen and progestin include the daily oral pill, monthly vaginal ring, and weekly transdermal patch. With full adherence, effectiveness of these methods is 2 pregnancies per 100 users per year. However, typical effectiveness is 4 to 7 pregnancies per 100 women per year, with variability in effectiveness related to the user’s adherence. 12 , 18 The importance of patient adherence to hormonal contraception was recently demonstrated by a cohort study of approximately 10 000 individuals in the US. Pregnancy rates were 4.55 per 100 participant-years for short-acting methods (pills, patch, ring) compared with 0.27 for long-acting reversible methods (IUD, implant). 13 Women younger than 21 years using short-acting methods had higher pregnancy risk as women 21 or older (adjusted hazard ratio, 1.9 [95% CI, 1.2-2.8]). 13 No risk differences by age were observed for the long-acting reversible methods of IUD or implant. Absolute rates were not reported by age stratum.

Combined hormonal contraceptives prevent pregnancy through the same mechanisms as progestin-only methods. Their greatest advantage over progestin-only methods is their ability to produce a consistent, regular bleeding pattern. In a study that compared bleeding diaries from 5257 women using 9 different methods of contraception (nonhormonal, combined hormonal contraception, and progestin-only), approximately 90% of combined hormonal contraception pill users (n = 1003) over a 90-day standard reference period reported regular scheduled withdrawal bleeds while no one experienced amenorrhea. 22 Occasionally, patients do not have a withdrawal bleed during the placebo week. A pregnancy test can be performed if the patient or clinician is concerned about the possibility of pregnancy as the reason for not bleeding. If pregnancy is ruled out, the lack of withdrawal bleeding is due to HPO axis suppression and patients can be reassured that lack of withdrawal bleeding does not indicate a health problem or reduced fertility.

Regardless of the route of delivery, ethinylestradiol and other estrogens are metabolized by the liver and activate the hemostatic system. The most significant risk of combined hormonal contraception is estrogen-mediated increases in venous thrombotic events. 23 - 25 Large international cohort studies have identified the risk of deep vein thrombosis at baseline in reproductive-aged women to be approximately 2 to 10 per 10 000 women-years. The risk associated with combined hormonal contraception is approximately 7 to 10 venous thrombotic events per 10 000 women-years. 26 - 28 The risk of venous thromboembolism is substantially greater in pregnancy. One UK study of 972 683 reproductive-aged women with 5 361 949 person-years of follow-up found a risk of deep vein thrombosis of 20 per 100 000 in women who were not pregnant. This rate increased to 114 per 100 000 women-years in the third trimester of pregnancy and to 421 per 100 000 in the first 3 weeks postpartum. 29 The absolute risk of ischemic stroke in reproductive-aged women not taking combined hormonal contraception is 5 per 100 000 women-years. 25 Combined hormonal contraception is associated with an additional absolute risk of approximately 2 per 100 000 (ie, overall risk of 7 per 100 000). 25 This study did not exclude women who smoked cigarettes or had hypertension. 25

Clinicians who prescribe combined hormonal contraception should counsel women regarding signs and symptoms of arterial and venous thrombosis, especially for women with multiple additional risk factors, including body mass index (calculated as weight in kilograms divided by height in meters squared) at or over 30, smoking, and age older than 35 years. While progestins are not associated with an increase in thromboembolic risks, 30 , 31 US Food and Drug Administration package inserts for these methods contain “class labeling” or the same risks as estrogen and progestin combined hormonal contraceptive methods. Patients at increased risk of thrombosis can be provided a progestin-only, nonestrogen-containing method because this method of contraception does not increase risk of venous thromboembolism. 32

Behavioral contraceptive methods include penile withdrawal before ejaculation and fertility awareness–based methods. Imprecise terms, such as natural family planning , the rhythm method , or other euphemisms may be used by patients when referring to these methods. The effectiveness of withdrawal and fertility awareness depends on patient education, cycle regularity, patient commitment to daily evaluation of symptoms (first morning temperature, cervical mucus consistency), and the patient’s ability to avoid intercourse or ejaculation during the time of peak fertility. Data on pregnancy rates are frequently of poor quality and highly dependent on study design. 33 A meta-analysis of higher-quality prospective studies of women at risk for undesired pregnancy reported failure rates of 22 pregnancies per 100 women-years for fertility awareness methods. 34

Other nonhormonal methods prevent sperm from entering the upper reproductive tract through a physical barrier (condoms and diaphragms) or through agents that kill sperm or impair their motility (spermicides and pH modulators). First-year typical use effectiveness for these methods is 13 pregnancies per 100 women in a year. 12 , 18

The copper-bearing IUD is a highly effective nonhormonal reversible method. 12 , 18 Typical use pregnancy rates are 1% per year. 12 , 18 There is no effect on a user’s HPO axis and thus ovulation and menstrual cyclicity continues. The primary mechanism of action is spermicidal, through direct effects of copper salts and endometrial inflammatory changes. 35 The major challenge with the copper IUD is that it can increase the amount, duration, and discomfort of menses mostly during the first 3 to 6 months of use. 36 IUD use does not increase later risk of tubal infertility. 37 If sexually transmitted infection (STI) testing is indicated, testing can be performed concurrently with IUD placement. 38 - 40 This expedited process of testing for STIs at the time of IUD placement does not increase the risk of pelvic inflammatory disease. The absolute risk of pelvic inflammatory disease after IUD insertion is low in those with (0%-5%) or without (0%-2%) existing gonorrhea or chlamydial infection. 41

Emergency contraception (EC) reduces pregnancy risk when used after unprotected intercourse. The most effective method of EC is a copper IUD, which reduces pregnancy risk to 0.1% when placed within 5 days of unprotected intercourse. 42 A copper IUD also has the added advantage of providing patients with ongoing contraception. LNG IUDs were not previously considered an option for EC. However, in a recent randomized noninferiority trial, women requesting EC who had at least 1 episode of unprotected intercourse within the prior 5 days were randomized to receive a copper IUD (n = 356) or a 52-mg LNG IUD (n = 355). 43 LNG IUD was noninferior to copper IUD (between-group absolute difference, 0.3% [95% CI, −0.9% to 1.8%]). However, the proportion of study participants who had unprotected intercourse midcycle (and therefore were at risk of pregnancy) was not reported. If a patient needs EC and wishes to initiate a 52-mg LNG IUD, it is reasonable to immediately place the IUD plus give an oral EC, 44 given the limited and indirect evidence supporting the LNG IUD alone for EC.

Quiz Ref ID Oral EC consists of a single dose of either a progestin (LNG, 1.5 mg) or an antiprogestin (ulipristal acetate, 30 mg). Both of these agents work by blocking or delaying ovulation. Neither is abortifacient. LNG EC is available over-the-counter; a prescription is needed for ulipristal acetate. The medication should be taken as soon as possible after unprotected intercourse for maximum efficacy but can be taken up to 5 days afterward for ulipristal acetate. 45 - 47 LNG efficacy is diminished after 3 days. Efficacy appears similar between the 2 agents when ingested within the first 72 hours after intercourse (ulipristal acetate EC: 15 pregnancies of 844, LNG EC: 22 pregnancies of 852; reduction in pregnancy without EC use estimated to be 90% less) but pharmacodynamic and clinical studies demonstrated that the ulipristal acetate treatment effect persists up to 120 hours with no pregnancies (0/97). 46 Actual use studies of EC that included 3893 individuals found lower pregnancy prevention rates than expected, which appears to be related to multiple acts of unprotected intercourse both before and after the EC use. 48 , 49 If further acts of unprotected intercourse occur 24 hours after EC use and a regular method of contraception has not been started, EC needs to be taken again. 49 Repeat use of LNG EC results in no serious adverse events; repeat dosing for ulipristal acetate EC has not been specifically studied. 50 Clinicians should review the options for EC with all patients starting a user-controlled method, such as condoms. These patients may be prescribed oral EC to keep at home for immediate use if needed.

Two evidence-based guidelines are available to assist clinicians in evaluating the safety of contraception initiation and use. 32 , 42 These guidelines were developed by the US Centers for Disease Control and Prevention, are updated regularly, and are freely available online and in smartphone apps.

The first is the US Medical Eligibility Criteria for Contraceptive Use 32 (US MEC), which provides information on the safe use of contraceptive methods for women with various medical conditions (eg, diabetes, seizure disorder) and other characteristics (eg, elevated body mass index, tobacco use disorder, postpartum). The US MEC uses a 4-tiered system to categorize level of risk for each disease/contraceptive method combination. 32 The risk tiers are (1) no restrictions exist for use of the contraceptive, (2) advantages generally outweigh theoretical or proven risks although careful follow-up might be required, (3) theoretical or proven risks outweigh advantages of the method and the method usually is not recommended unless other more appropriate methods are not available or acceptable, and (4) the condition represents an unacceptable health risk if the method is used. 32

All clinicians, including advanced practice clinicians, should be familiar with prescribing within US MEC categories 1 and 2 (no restrictions or benefits outweigh risks). For women with underlying health conditions who want to use a category 3 method, such as a woman with a history of breast cancer choosing combined hormonal contraceptives, primary care physicians or specialists should review the detailed evidence listed in the US MEC to advise their patients. Subspecialists in complex family planning who have completed extra fellowship training may provide helpful consultation for patients with multiple contraindications or unusual situations. The US MEC is a guideline, not a mandate. Situations may arise in which specialists recommend an MEC category 3 or 4 method because the alternative to the contraceptive method, pregnancy, places the patient at even greater risk. 32 The US MEC does not include conditions for which there is insufficient evidence to make recommendations, such as aortic aneurysms, Marfan syndrome, or chronic marijuana use. For these patients, clinicians should consider referral to a complex family planning specialist. If the patient needs a method immediately, a progestin-only pill should be considered as a “bridging” method, because these can be used safely by most patients 32 and are more effective than barrier methods such as condoms.

The US MEC addresses common drug interactions with hormonal contraceptives. 32 Contraceptive steroid hormones are metabolized via the hepatic cytochrome P450 pathway. 51 , 52 Drugs that induce this pathway, such as rifampin and barbiturates, or chronic alcohol can impair contraceptive efficacy and drugs that inhibit the pathway, such as valproic acid, cimetidine, or fluconazole, may increase adverse effects. The FDA recognizes a drug-drug interaction as clinically significant if it causes at least a 20% difference in drug levels 53 but an interaction does not necessarily affect contraceptive failure rates. Adherence, continuation, fecundity, and frequency of intercourse also contribute to contraceptive effectiveness. Additionally, most pharmacokinetic studies do not have sufficient statistical power to determine differences in pregnancy rates. The most common drug classes that may interact with hormonal contraceptives are antiretroviral drugs (including efavirenz and ritonavir-boosted protease inhibitors) and anticonvulsant therapies (including carbamazepine, phenytoin, and others). 54 , 55 Evidence from both clinical and pharmacokinetic studies of routinely used antibiotics do not support impaired contraceptive efficacy with concomitant antibiotic prescription, 56 except for rifampin with which ethinylestradiol and progestin area under the curve levels are at least 40% lower. 57 Because the local progestin dose in the LNG IUD is so high, its efficacy is not reduced by drugs that may affect combined hormonal contraceptives, progestin-only contraceptive pills, or the progestin implant. While hormonal contraceptive use can change concentrations of some drugs, 58 this is rarely clinically relevant, except for the reduction in serum concentration of the anticonvulsant lamotrigine.

Another major guideline is the US Selected Practice Recommendations for Contraceptive Use 42 (US SPR, available online or via a smartphone app). The US SPR is organized by contraceptive method. It includes method-specific, up-to-date guidelines, such as how to initiate the method, how to manage bleeding irregularities, and recommended follow-up. For example, the guidelines on IUDs include evidence on medications to ease IUD insertion or IUD management if a pelvic infection occurs. Recommendations related to combined hormonal contraceptives include the number of pill packs that should be provided at initial and return visits or management of vomiting or severe diarrhea while using combined oral contraceptives.

Much of the data on noncontraceptive benefits of hormonal methods come from case-control studies or small comparative trials. However, fair evidence exists that methods that suppress ovulation can be effective in reducing benign ovarian tumors 59 and functional ovarian cysts. 60 Combined hormonal contraceptives diminish hormonally mediated premenstrual dysphoric disorder, with statistically significant mean differences in symptoms, such as headaches, bloating, and fatigue, and functionality scales. 61 The estrogen component of combined hormonal contraception increases hepatic sex hormone–binding globulin, which reduces free testosterone and improves androgen-sensitive conditions, such as acne and hirsutism. Cochrane systematic reviews of combined hormonal contraceptives and both conditions show significant associations with improvement in a variety of measures of acne and hirsutism. 62 , 63 All progestin-containing contraceptives cause endometrial atrophy and, thus, reduce menstrual blood loss and menstrual pain to varying extents. 64 - 66 While progestin-only methods can promote unscheduled or breakthrough bleeding, the total amount of blood loss is reduced and in those with heavy menstrual bleeding, hemoglobin levels can rise by 10 g/L in 12 months. 67 , 68 The LNG IUD has demonstrated efficacy in reduction of heavy menstrual bleeding 69 , 70 (including for women with anticoagulation, fibroids, 71 or hemostatic disorders), primary dysmenorrhea, 36 , 72 endometriosis, 73 adenomyosis, 74 and protection against pelvic infection. 75

Screening for pregnancy is important prior to prescribing contraception. According to the US SPR, clinicians should be “reasonably certain” that the patient is not pregnant. 42 A clinician can be reasonably certain that a woman is not pregnant if she has no symptoms or signs of pregnancy and meets any 1 of the following criteria: (1) is 7 days or less after the start of normal menses; (2) has not had sexual intercourse since the start of last normal menses; (3) has been correctly and consistently using a reliable method of contraception; (4) is 7 days or less after spontaneous or induced abortion; (5) is within 4 weeks’ postpartum; and (5) is fully or nearly fully breastfeeding (exclusively breastfeeding or most [≥85%] of feeds are breastfeeds), amenorrheic, and less than 6 months postpartum.

Quiz Ref ID These criteria have a negative predictive value of 99% to 100%. 76 - 78 A urine pregnancy test (UPT) alone is not sufficient to exclude pregnancy. UPT sensitivity is dependent on when the last act of intercourse occurred, the ovulatory cycle phase, and urine concentration. Sensitivity of UPTs is 90% at the time of a missed period, but only 40% in the week prior. 79 Additionally, a UPT can remain positive up to 4 weeks after delivery, miscarriage, or abortion. 80 , 81 Few other tests are required for safe and effective use of contraception.

Clinicians can offer other indicated preventive health tests at the contraceptive initiation visit, like screening for cervical cancer or STIs. However, these tests are not required for contraceptive use and should not prevent initiation of contraception.

Generally, all methods should be started immediately on prescription regardless of menstrual cycle day—known as the Quick Start protocol. 82 If a hormonal method is initiated within 5 days of the first day of menses, no additional backup method is needed. At other times in the cycle, or when switching from a nonhormonal to a hormonal method, a backup is necessary for 7 days to ensure ovulation suppression. If switching from one hormonal method to another, the switch can occur without a withdrawal bleed or backup.

If a woman reports unprotected intercourse within the 5 days before contraceptive initiation, most sources recommend giving emergency contraception, initiating her desired method, and repeating a UPT 2 to 3 weeks later. 82 - 85 Many studies have demonstrated that exposing an early pregnancy to hormonal contraception is not harmful 86 but delayed initiation increases the risk of undesired pregnancy.

Because comparative effectiveness studies to clearly identify the superiority of one contraceptive pill formulation over another are lacking, selecting a contraceptive pill often depends on patient experience. Monophasic regimens, in which each pill has the same hormone doses, have significant advantages over bi- and triphasic regimens. Cycles can be extended easily by skipping the placebo week and starting the next pack of active pills. If this is attempted with multiphasic regimens, the drop in progestin between phases typically results in breakthrough bleeding. In terms of ethinylestradiol, few patients require a pill containing more than 35 µg/d to prevent breakthrough bleeding. 87 Many clinicians advocate starting with the lowest ethinylestradiol dose to minimize risks. However, there are no data demonstrating that 10- to 20-µg/d ethinylestradiol doses are safer than 35 µg daily, and lower ethinylestradiol doses are associated with more unscheduled vaginal bleeding. 88 Thus, starting with a monophasic preparation containing 30 µg to 35 µg of ethinylestradiol provides the greatest likelihood of a regular bleeding pattern without increasing risk. Ethinylestradiol can be reduced if patients have estrogen-associated adverse effects, such as nausea or breast tenderness.

Many different progestins exist. Progestins differ in in vitro androgenicity, effects on surrogate metabolic markers, or similarity to testosterone. 89 While molecular structures differ, there is no evidence demonstrating that a particular progestin is superior to others. Traditionally, progestins were classified into “generations” by their parent compound and decade of development. This classification is not clinically useful and should be abandoned. 90 Patients sometimes prefer a pill that they used previously, and if no contraindications exist and the cost is acceptable to the patient, it is reasonable to prescribe it ( Figure 1 and Figure 2 ).

Combined hormonal contraceptives can be dosed in a cyclic or continuous fashion. Originally, birth control pills were dosed with 21 days of active drug and a 7-day placebo week to trigger a monthly withdrawal bleed, meant to mimic the natural menstrual cycle. However, many women prefer less frequent withdrawal bleeds. 91 Some women report significant adverse effects 92 during this placebo week, such as migraine, bloating, and pelvic pain, and extended use provides an easy way to manage or eliminate these problems. 61 During the placebo week, there is less suppression of the HPO axis. 93 - 95 For these reasons, many newer contraceptive pills have shorter (eg, 4-day) placebo periods. Further, most monophasic combined hormonal contraceptives can be used as extended use (fewer withdrawal bleeds) by having a 4-day placebo period quarterly or continuously (no withdrawal bleed) by eliminating the placebo altogether. Extended and continuous use are associated with improved typical use efficacy, likely because greater overall HPO axis suppression is achieved, which may offset lapses in user adherence. 96 A new vaginal ring (segesterone acetate/ethinyl estradiol vaginal system) is also available, which is prescribed for 1 year, with the patient removing the ring each month for 7 days. 97

This review has several limitations. First, relatively few randomized clinical trials that directly compared contraceptive methods were available. Therefore, contraceptive methods are typically evaluated by their individual efficacy (pregnancies per person-cycles) and not typically by their relative effectiveness compared with another method. Second, the quality of summarized evidence was not evaluated. Third, some aspects of contraception, such as counseling, noncontraceptive health benefits, ongoing contraceptive innovations, and the effect of cultural values, and patient preferences were not covered in this review.

Oral contraceptive pills are the most commonly used reversible contraceptives, IUDs and subdermal implants have the highest effectiveness, and progestin-only and nonhormonal methods have the lowest risks. Optimal contraceptive selection incorporates patient values and preferences.

Corresponding Author: Stephanie Teal, MD, MPH, Department of OB/GYN, University Hospitals Medical Center and Case Western Reserve University, 11100 Euclid Ave, MAC-5304 Cleveland, OH 44106 ( [email protected] ).

Accepted for Publication: November 10, 2021.

Author Contributions: Drs Teal and Edelman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design : Both authors.

Acquisition, analysis, or interpretation of data : Both authors.

Drafting of the manuscript : Both authors.

Critical revision of the manuscript for important intellectual content : Edelman.

Administrative, technical, or material support : Both authors.

Supervision : Both authors.

Conflict of Interest Disclosures: Dr Teal reported receiving grants from Merck & Co, Bayer Healthcare, Sebela, and Medicines360, and personal fees from Merck & Co and Bayer Healthcare outside the submitted work. Dr Edelman reported receiving grants from Merck, research funds from HRA Pharma, and royalties from UpToDate outside the submitted work.

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