Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews.

OBJECTIVE: We investigated whether participants in a phase II randomized clinical trial of a candidate vaginal microbicide ever intentionally misled interviewers. STUDY DESIGN AND SETTING: We used audio computer-assisted self-interviews (ACASI) to ask the South African women (n=132) participating in the trial about the accuracy of self-reported data collected during face-to-face interviews. The trial protocol recommended that women use their assigned gel (active microbicide or placebo) with condoms during each vaginal sex act. RESULTS: Nearly four-fifths of participants (n=104, 79%) reported that they had misinformed trial interviewers at least once. Motivations included politeness (n=45, 34% of ACASI participants) to avoid criticism or seek praise (n=32, 24%), and embarrassment (n=24, 18%). Participants acknowledged misreporting eligibility characteristics to enroll (11%) and, during follow-up, exaggerating their enthusiasm for the study gel (13%), applicator (13%), and the effect of the gel on sexual pleasure (13%). In general, women who were untruthful had actually used the gel with condoms less and used the gel alone more than they had reported during the trial. Women overwhelmingly found the computer survey easy. CONCLUSION: Researchers cannot assume that participants always tell the truth about sensitive behaviors in face-to-face interviews. ACASI was efficient and acceptable in this population.

Risk of pregnancy and external validity in clinical trials of emergency contraception.

OBJECTIVES: To compare women who enroll in emergency contraception (EC) trials to those who decline and to understand why eligible women decline to participate. METHODS: Data were collected from all women seeking EC (n = 5,787) at three clinics in the USA and UK during a period of nearly 1 year (from September 1997 to August 1998). The main outcome measures were pregnancy risk calculated by adjusted cycle day of ovulation. RESULTS: Enrolled and non-enrolled women had similar mean ages and similar mean cycle lengths. However, the enrolled and non-enrolled groups were different with respect to adjusted cycle day of unprotected sexual intercourse (UPSI), the regularity of their cycles, recent hormone use, breastfeeding, the number of other acts of UPSI they had engaged in during the same cycle, and their willingness to participate in the study. Expected pregnancy risk among enrolled patients was higher than among non-enrolled EC seekers (6.5% vs 5.0%, p<0.001, calculated using Dixon conception probabilities, and 5.4% vs 4.6%, p = 0.086, calculated using Trussell conception probabilities). Unwillingness to take part in the study was the most common reason women did not enrol in the trial. Otherwise-eligible women most often declined to enrol because they were concerned about the effectiveness of the trial regimen. CONCLUSIONS: Women in EC trials are likely to face higher pregnancy risk than the general population. Clinical trials might overestimate the number of pregnancies averted by treatment because the number of expected pregnancies in trial populations is not representative of the population of all EC seekers. This information could be useful in projecting the public health impact of expanded EC access.

Barriers to contraceptive use in product labeling and practice guidelines.

Many contraceptives are encumbered with potentially unnecessary restrictions on their use. Indeed, fear of side effects, fostered by alarmist labeling, is a leading reason that women do not use contraceptives. In the United States, hormonal methods currently require a prescription, although research suggests that women can adequately screen themselves for contraindications, manage side effects, and determine an appropriate initiation date, leaving little need for routine direct physician involvement. Sizing, spermicidal use, and length-of-wear limits burden users of cervical barriers and may be unnecessary. Despite recent changes in the labeling of intrauterine devices, clinicians commonly restrict use of this method and in some countries may limit the types of providers authorized to insert them. Although in some cases additional research is necessary, existing data indicate that evidence-based demedicalization of contraceptive provision could reduce costs and improve access.

Accounting for time: insights from a life-table analysis of the efficacy of medical abortion.

OBJECTIVE: Previously published analyses have ignored the temporal nature of medical abortion and calculated effectiveness as the proportion of abortions that succeed. By using life tables, we incorporate the important element of time to produce unbiased efficacy rates as well as afford insight into the medical abortion process. STUDY DESIGN: Using data on 6568 women from 6 previously published mifepristone-misoprostol medical abortion studies, we generated multidecrement life table efficacy curves and evaluated the cumulative probability of successful medical abortion. RESULTS: Efficacy rates calculated using proportions are biased because of loss to follow-up. Compliance with the medical abortion regimen was high. More than 80% of abortions were complete within a week of receiving mifepristone. Success continued to improve thereafter. Most surgical interventions were unnecessary. CONCLUSION: Follow-up visits can be scheduled within a week of receiving mifepristone; however, aspirations should not be performed routinely if the abortion is not complete.

Physicians' knowledge and opinions about medication abortion in four Latin American and Caribbean region countries.

To examine physicians' knowledge and attitudes in regard to medication abortion, we conducted focus-group discussions with general practice physicians and obstetrician-gynecologists in Honduras, Mexico, Nicaragua and Puerto Rico. Physicians were familiar with the practice of several types of medication and surgical abortion methods. Medication abortion with misoprostol is most common among women of higher socioeconomic status and is prescribed by physicians, pharmacists or self-administered. Conflicting opinions regarding safety, efficacy, cost, potential for self-medication and acceptability emerged; some participants expressed hope that medical abortion would reduce the risks associated with unsafe abortion, while others contended that drug distribution and self-medication without proper counseling could be problematic. Participants noted a lack of reliable sources of information for both providers and women, and expressed interest in strategic dissemination of information.

The role of emergency contraception.

Emergency contraception is an underused therapeutic option for women in the event of unprotected sexual intercourse. Available postcoital contraceptives include emergency contraceptive pills (ECPs) both with and without estrogen, and copper-bearing intrauterine devices. Each method has its individual efficacy, safety, and side effect profile. Most patients will experience prevention of pregnancy, providing they follow the treatment regimen carefully. There are concerns that women who use ECPs may become lax with their regular birth control methods; however, reported evidence indicates that making ECPs more readily available would ultimately reduce the incidence of unintended pregnancies. In addition, it is typically conscientious contraceptive users who are most likely to seek emergency treatment. Patient education is paramount in the reduction of unintended pregnancies and there are numerous medical resources available to women to assist them in this endeavor. Finally, ECPs are associated with financial and psychologic advantages that benefit both the individual patient and society at large.

Routine follow-up visits after first-trimester induced abortion.

Routine follow-up visits after abortion are intended to confirm that the abortion is complete and to diagnose and treat complications. Many clinicians also take advantage of the follow-up visit to provide general reproductive health care: discussing contraceptive plans and providing family planning services; diagnosing sexually transmitted infections; performing a Pap test or discussing abnormal Pap results. We reviewed the evidence related to the routine postabortion follow-up visit. Other than mifepristone medical abortion performed at 50 days of gestation or later and methotrexate medical abortion, we found little evidence that mandatory follow-up visits typically detect conditions that women themselves could not be taught to recognize. In addition, the natural history of the most severe complications after abortion-infection and unrecognized ectopic pregnancy-have time courses inconsistent with the usual timing of the follow-up visit. Costs associated with this visit can be great. These include travel expenses, lost wages, child-care expenses, privacy and emotional burdens for women, and scheduling disruptions and the related opportunity costs caused by "no-shows" for the provider. Follow-up appointments should be scheduled for those women likely to benefit from a physical examination. For the remainder of women, simple instructions and advice about detecting complications, possibly coupled with telephone follow-up, might suffice. Although arguably valuable in their own right, counseling, family planning services, or sexually transmitted infection diagnosis and treatment should not be so inflexibly bundled with postabortion care. Protocols that require in-person follow-up after abortion may not make the best use of a women's time or abilities, or of the medical system.

Do Mexico City pharmacy workers screen women for health risks when they sell oral contraceptive pills over-the-counter?

CONTEXT: In Mexico, oral contraceptives (OCs) are available to women over-the-counter in pharmacies. While past research has suggested that nonmedical providers, such as pharmacy workers, are capable of screening women for contraindications to OCs, little is known about their practices. METHODS: After selecting a 10% random sample of all pharmacies in Mexico City (n = 108), we surveyed the first available pharmacy worker to learn more about pharmacy workers' screening practices when selling OCs over-the-counter to women. RESULTS: While nearly all of the pharmacy workers surveyed had sold OCs without a prescription, only 31% reported asking women any questions before selling pills. Among those who asked questions, the most commonly asked questions were about other medications a woman was taking, about blood pressure and about alcohol intake. Pharmacy workers did not ask these questions consistently to all clients. CONCLUSION: Training pharmacy workers might be one strategy to improve screening of women for pill contraindications. However, pharmacy workers may lack the time and motivation to carry out such screening. An alternative strategy might be to better inform women to self-screen for pill contraindications.

Side effects of the Yuzpe regimen of emergency contraception and two modifications.

We investigated side effects after the standard Yuzpe regimen or two modifications: substituting norethindrone as the progestin or eliminating the second dose. We also examined the impact of taking either dose with food. Nearly two thirds of women reported at least one side effect, the majority of which were mild or moderate. Women in our study experienced more side effects after the second dose than after the first. Taking the first dose within 1 h of a meal or snack was associated with increased nausea and vomiting; taking the second dose within 1 h of a meal or snack was associated with decreased nausea and vomiting. A targeted approach to prophylactic antiemetic use could reduce the number of women given these drugs, and the number who experience unnecessary side effects. The impact of counseling on side effects should be further evaluated.

As often as needed: appropriate use of emergency contraceptive pills.

Previous research has established that emergency contraceptive pills are safe and have the potential to reduce unintended pregnancy; however, policy makers, providers and even women themselves have expressed concern about repeat use of the method. Evidence regarding the safety, efficacy and frequency of repeat use show that the method is safe and effective, even when used multiple times. Reported rates of repeat use are actually lower than would be expected, and needed, based on the frequency of unprotected intercourse and contraceptive failure reported in most countries. Healthcare providers should encourage use of emergency contraceptive pills as a backup after recognizable failure of barrier methods or other hormonal contraceptive methods, and should expect that women may need emergency contraceptive pills multiple times during their reproductive years.

Differences in efficacy, differences in providers: results from a hazard analysis of medical abortion.

Sample sizes of even the largest medical abortion trials are generally not adequate to provide an understanding of how well the regimen works for subgroups of women, particularly when controlling for factors known to influence efficacy, such as gestational age. By pooling data from four previously published studies of medical abortion and using hazard analyses, we can undertake such an investigation. We find that women with lower gestational ages, women younger than 23 years of age, women with more than 12 years of education and women with no previous induced abortion experience were more likely to experience a successful medical abortion. After taking into account demographic factors, we find that significant differences in efficacy persist across study sites, indicating that differences in providers' tendency to intervene by performing vacuum aspiration vary across medical abortion providers.

Emergency contraception and morality: reflections of health care workers and clients.

In this study, we explore the retrospective reports of 21 US Planned Parenthood clients about their use of emergency contraception pills (ECPs) and the views of ten Planned Parenthood health care workers at two clinics about providing ECPs. We elucidate the sociological phenomena that frame emergency contraception usage: cultural ideology about contraception, sexuality, unintended pregnancy, and abortion. We focus on the ways in which interactions between health care workers and clients both mediate and reinforce such cultural ideology. Our research indicates that the distinctions between fertilization and pregnancy, between contraception and abortion, between responsible and irresponsible procreative behavior, are not hard and fast boundaries upon which everyone agrees. We illuminate the dividing lines and continuities our participants invoked, affirmed, and questioned when contemplating the continuum from potential fertility to realized (and unwanted) pregnancy.

Policy implications of a national public opinion survey on abortion in Mexico.

In Mexico, recent political events have drawn increased public attention to the subject of abortion. In 2000, using a national probability sample, we surveyed 3000 Mexicans aged 15-65 about their knowledge and opinions on abortion. Forty-five per cent knew that abortion was sometimes legal in their state, and 79% felt that abortion should be legal in some circumstances. A majority of participants believed that abortion should be legal when a woman's life is at risk (82%), a woman's health is in danger (76%), pregnancy results from rape (64%) or there is a risk of fetal impairment (53%). Far fewer respondents supported legal abortion when a woman is a minor (21%), for economic reasons (17%), when a woman is single (11%) or because of contraceptive failure (11%). In spite of the influence of the Church, most Mexican Catholics believed the Church and legislators' personal religious beliefs should not factor into abortion legislation, and most supported provision of abortions in public health services in cases when abortion is legal. To improve safe, legal abortion access in Mexico, efforts should focus on increasing public knowledge of legal abortion, decreasing the Church's political influence on abortion legislation, reducing the social stigma associated with sexuality and abortion, and training health care providers to offer safe, legal abortions.

Abortion, contraceptive use, and adolescent pregnancy among first-year medical students at a major public university in Mexico City.

OBJECTIVE: If properly trained, medical students could become future opinion leaders in health policy and could help the public to understand the consequences of unwanted pregnancies and of abortions. The objective of this study was to analyze the frequency of unwanted pregnancies and induced abortions that had occurred among women who were first-year medical students at a major public university in Mexico City and to compare the experiences of those women with the experiences of the general population of Mexican females aged 15 to 24. METHODS: In 1998 we administered a cross-sectional survey to all the first-year medical students at the National Autonomous University of Mexico, which is the largest university in Latin America. For this study we analyzed 549 surveys completed by female students. RESULTS: Out of the 549 women, 120 of them (22%) had been sexually active at some point. Among those 120 sexually active students, 100 of them (83%) had used a contraceptive method at some time, and 19 of the 120 (16%) had been pregnant. Of those 19 women who had been pregnant, 10 of them had had an illegal induced abortion (in Mexico, abortions are illegal except under a small number of extenuating circumstances). The reported abortion rate among the female medical students, 2%, was very low in comparison with the 11% rate for women of similar ages in the Mexican general population. CONCLUSIONS: The lower incidence of abortion among the female medical students indicates that when young Mexican women have access to medical information and are highly motivated to avoid unintended pregnancy and abortion, they can do so.

Abortion, contraceptive use, and adolescent pregnancy among first-year medical students at a major public university in Mexico City

OBJECTIVE: If properly trained, medical students could become future opinion leaders in health policy and could help the public to understand the consequences of unwanted pregnancies and of abortions. The objective of this study was to analyze the frequency of unwanted pregnancies and induced abortions that had occurred among women who were first-year medical students at a major public university in Mexico City and to compare the experiences of those women with the experiences of the general population of Mexican females aged 15 to 24. METHODS: In 1998 we administered a cross-sectional survey to all the first-year medical students at the National Autonomous University of Mexico, which is the largest university in Latin America. For this study we analyzed 549 surveys completed by female students. RESULTS: Out of the 549 women, 120 of them (22 percent) had been sexually active at some point. Among those 120 sexually active students, 100 of them (83 percent) had used a contraceptive method at some time, and 19 of the 120 (16 percent) had been pregnant. Of those 19 women who had been pregnant, 10 of them had had an illegal induced abortion (in Mexico, abortions are illegal except under a small number of extenuating circumstances). The reported abortion rate among the female medical students, 2 percent, was very low in comparison with the 11 percent rate for women of similar ages in the Mexican general population. CONCLUSIONS: The lower incidence of abortion among the female medical students indicates that when young Mexican women have access to medical information and are highly motivated to avoid unintended pregnancy and abortion, they can do so.

Knowledge and perceptions of HIV among peripartum women and among men whose wives are of reproductive age, northern Thailand.

To investigate knowledge and perceptions of HIV transmission risk and interest in vaginal microbicides in northern Thailand, we conducted 14 focus group discussions and 80 interviews with men and women in Chiang Rai province. Women were recruited from antenatal or postpartum clinics, and men from various work sites. Participants evinced substantial knowledge about HIV, with two exceptions important for prevention campaigns: (a) confusion about the window period between a new infection and positive HIV-test result and (b) overestimation of the safety of extramarital sex with partners who are not sex workers. Most participants reported no personal HIV risk. Participants described Thai women as generally vulnerable to HIV infection because of the unlikelihood of condom use with their husbands and because women cannot control their husbands' extramarital behavior. Women apparently face particular risk after childbearing; peripartum abstinence averages 6-9 months, during which time some Thai men may have alternative sex partners. Women, and to a lesser degree, men were interested in potential microbicides, although they voiced many thoughtful questions about the products and about efficacy trials.

Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours.

OBJECTIVE: Current protocols state that the Yuzpe regimen of emergency contraception can be initiated up to 72 hours after unprotected intercourse. The purpose of this study was to determine whether the window for emergency hormonal contraception can be extended to 120 hours. METHODS: In an observational study, we tracked 111 women who requested emergency contraception between 72 and 120 hours after unprotected sex but refused postcoital copper intrauterine devices (IUDs), preferring instead the Yuzpe regimen. We compared failure rates for this group with rates among 675 otherwise similar women who started the same therapy within 72 hours. RESULTS: Both perfect use (1.9%) and typical use (3.6%) failure rates were low among women presenting between 72 and 120 hours after unprotected intercourse. These rates did not statistically differ from failure rates for the standard Yuzpe regimen (2.0% during perfect use and 2.5% during typical use). Our small sample size of 111, however, gave us just 25% power to detect a doubling in the failure rates (2% to 4%) and 59% power to detect a tripling in the failure rates (2% to 6%). CONCLUSION: The 72-hour cutoff for the Yuzpe regimen of emergency contraception appears needlessly restrictive. Women who request this therapy more than 72 hours after unprotected sex should be allowed to receive it, particularly if they decline postcoital insertion of a copper IUD and would otherwise have no options for reducing pregnancy risk.

Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial.

OBJECTIVE: Emergency contraceptives can prevent unintended pregnancy after unprotected intercourse. The best-studied regimen ("Yuzpe") consists of ordinary combined oral contraceptives containing levonorgestrel and ethinyl estradiol. Women traditionally take one dose within 72 hours after unprotected intercourse, and a second dose 12 hours later. Historically, half experience nausea and a fifth vomit. The purpose of this study was to determine whether 1). women could use combined oral contraceptives other than those containing levonorgestrel and 2). eliminating the second dose improves comfort and convenience. METHODS: Women presenting within 72 hours after unprotected intercourse were randomized to receive 1). standard two-dose Yuzpe, 2). a variant of Yuzpe substituting norethindrone for levonorgestrel, or 3). only the first dose of Yuzpe, followed 12 hours later by a placebo. RESULTS: Perfect-use failure rates were low in all groups and did not differ in a statistically significant way (standard Yuzpe 2.0% [n = 589], norethindrone-ethinyl estradiol 2.7% [n = 547], single dose of Yuzpe 2.9% [n = 546]). Typical-use failure rates were slightly higher but similarly did not differ significantly. Side effects were similar across groups, except that women taking the single dose reported half the vomiting. Taking the pills with food did not seem to reduce nausea or vomiting, and the pills were not more effective when started sooner after unprotected intercourse. CONCLUSION: Oral contraceptives containing norethindrone-ethinyl estradiol work approximately as well for emergency contraception as levonorgestrel-ethinyl estradiol formulations and should be offered when first-line therapies are not available.

Estimating the effectiveness of emergency contraceptive pills.

OBJECTIVE: We use new estimates of conception probabilities by cycle day of intercourse, where cycle day is measured with day 1 being the first day of bleeding in a cycle, to propose a new approach for estimating the effectiveness of emergency contraceptive pills (ECPs). We use this new approach to examine the absolute effectiveness and the cost-effectiveness of ECPs and whether ECPs are more effective the sooner after unprotected intercourse they are initiated. METHODS: Using the new set of conception probabilities, we employ data from two recent clinical trials of ECPs, one from the Population Council and the other from the World Health Organization (WHO), to examine the effectiveness of the combined ECP regimen. RESULTS: The expected pregnancy rate among typical users was 6.2% in the Population Council trial and 7.4% in the WHO trial based on conception probabilities by cycle day relative to the day of ovulation. Based on conception probabilities by cycle day relative to the first day of bleeding, the expected pregnancy rates dropped to 5.4% and 5.2%, respectively. The two trials yield conflicting evidence regarding whether effectiveness declines with treatment delay. CONCLUSIONS: Our results suggest that the absolute levels of effectiveness for the Yuzpe regimen of emergency contraception and the cost-effectiveness of this regimen have probably been overstated when based on conception probabilities by cycle day relative to day of ovulation.