Side effects of mifepristone-misoprostol abortion versus surgical abortion. Data from a trial in China, Cuba, and India.

Although serious adverse events of early abortion have been studied, little attention has been paid to the more common side effects experienced by early medical or surgical abortion clients. Using data from a multicenter comparative trial of women < or = 56 days' gestation in China, Cuba, and India (n = 1373), side effects experienced by mifepristone-misoprostol medical abortion and surgical abortion clients were analyzed at the different stages of their abortions. Data on side effects came from women's reports at each clinic visit, providers' observations during the clinic visits, and symptom diaries maintained during the study period. Medical abortion clients at all sites experienced more side effects than their surgical counterparts. The disparity between the two groups was particularly pronounced for bleeding and pain. Despite more reports of side effects among medical abortion clients, however, assessments of well-being and reports of satisfaction at the exit interview were similar in both treatment groups.

Mifepristone-misoprostol medical abortion: home administration of misoprostol in Guadeloupe.

Mifepristone-misoprostol medical abortion promises to revolutionize reproductive health-care. Several simplifications of the standard three clinic visit regimen may be possible, however. Particularly in developing countries, access to the method can be greatly increased by eliminating the longest clinic visit. Indeed, shortly after mifepristone's introduction in Guadeloupe, a semi-developed Caribbean territory administered by France, in 1991, two of the authors conducted a small prospective study of a one treatment-visit regimen. The study regimen was subsequently adopted as the standard of care for medical abortion on the island. Women (n = 92) with amenorrhea of < or = 49 days received 600 mg mifepristone under clinical supervision and were given 400 micrograms oral misoprostol for home administration 2 days later, returning 2 weeks later for follow-up. The success rate (95.4%) is comparable to rates found when both drugs are administered in the clinic and to rates from a similar study conducted recently in the United States. Adverse events were also comparable to protocols requiring in-clinic administration of misoprostol. Protocol adherence appeared to be excellent and loss to follow-up was rare. We suggest that home administration of misoprostol can be safe and effective in most nonindustrialized settings.

PIP: This paper presents a prospective study of home administration and a one-treatment-visit regimen of mifepristone-misoprostol for medical abortion in Guadeloupe. The administration of this contraceptive method usually requires a standard 3-clinic visit regimen, which would sometimes lead to discontinuation of the abortion process. The study consisted of 92 medical abortion cases conducted over a 13-month period. The intervention involved a 1-day treatment visit with patients receiving 600 mg of mifepristone and instructions on ingesting 2 tablets (400 mcg) of misoprostol orally after 2 days and another 200 mcg misoprostol if bleeding had not occurred within 6-12 hours. A follow-up was conducted among these women after 10-15 days of initial clinic visit and contraceptive administration. The total success rate was 95.4% in comparison with those who received a 3-clinic visit regimen and the statistical result of a study conducted in the US. Several adverse effects have been associated with the administration of abortive methods, which include bleeding (19.6% in mifepristone users and 68.2% in misoprostol users) and vomiting. Strict monitoring of mifepristone and misoprostol distribution and patient follow-up was ensured by French legislators. The authors conclude that home administration of misoprostol must be made available to women in developing countries.

Emergency contraception in Mexico City: what do health care providers and potential users know and think about it?

Emergency contraception promises to reduce Mexico's high unwanted pregnancy and unsafe abortion rates. Because oral contraceptives are sold over-the-counter, several emergency contraceptive regimens are already potentially available to those women who know about the method. Soon, specially packaged emergency contraceptives may also arrive in Mexico. To initiate campaigns promoting emergency contraception, we interviewed health care providers and clients at health clinics in Mexico City, ascertaining knowledge, attitudes, and practices concerning the method. We found limited knowledge, but nevertheless cautious support for emergency contraception in Mexico. Health care providers and clients greatly overestimated the negative health effects of emergency contraception, although clients overwhelmingly reported that they would use or recommend it if needed. Although providers typically advocated medically controlled distribution, clients believed emergency contraception should be more widely available, including in schools and vending machines with information prevalent in the mass media and elsewhere.

PIP: An interview was conducted to ascertain knowledge, attitudes, and practices concerning emergency contraception (EC) among health care providers and potential EC users in metropolitan Mexico. Findings showed that there was a limited knowledge about EC per se and its method, but nevertheless, most of the participants were cautious to support EC in Mexico. Health care providers and clients greatly overestimated the negative health effects of EC, although clients overwhelmingly reported that they would use or recommend it if needed. Although providers typically advocated medically controlled distribution, clients believe EC should be more widely available, including in schools and vending machines, with information prevalent in the mass media and elsewhere.

What do family planning clients and university students in Nairobi, Kenya, know and think about emergency contraception?

Currently, emergency contraception is seldom used in Kenya. As part of a larger study designed to provide insight into the possible roles for the method in Kenya, we assessed the knowledge of and attitudes towards emergency contraception in two groups of potential users, and we focus on these data specifically in this paper. We interviewed clustered samples of clients at ten family planning clinics in Nairobi (n = 282) and conducted four focus group discussions with students at two universities in Kenya (n = 42). Results show that despite relatively low levels of awareness and widespread misinformation, when the method was explained, both clients and students expressed considerable interest, but also expressed some health and other concerns.

Understanding women's experiences with medical abortion: In-depth interviews with women in two Indian clinics.

We explored women's perspectives on using medical abortion, including their reasons for selecting the method, their experiences with it and their thoughts regarding demedicalisation of part or all of the process. Sixty-three women from two urban clinics in India were interviewed within four weeks of abortion completion using a semi-structured in-depth interview guide. While women appreciated the non-invasiveness of medical abortion, other factors influencing method selection were family support and distance from the facility. The degree of medicalisation that women wanted or felt was necessary also depended on the way expectations were set by their providers. Confirmation of abortion completion was a source of anxiety for many women and led to unnecessary interventions in a few cases. Ultimately, experiences depended more on women's expectations about the method, and on the level of emotional and logistic support they received rather than on inherent characteristics of the method. These findings emphasise the circumstances under which women make reproductive choices and underscore the need to tailor service delivery to meet women's needs. Women-centred counselling and care that takes into consideration individual circumstances are needed.

Acceptability and feasibility of early pregnancy termination by mifepristone-misoprostol. Results of a large multicenter trial in the United States. Mifepristone Clinical Trials Group.

OBJECTIVES: To evaluate whether the regimen of oral mifepristone and misoprostol for medical abortion is acceptable to women and providers, in the United States, including physicians, nurses, and counselors, and whether proposed modifications of this regimen appear feasible for clinical practice. DESIGN: A prospective study. SETTING: Seventeen clinics in 15 states. PARTICIPANTS: A total of 2121 women with pregnancies of 63 days or less in duration. INTERVENTIONS: The administration of mifepristone, 600 mg, orally, followed after 2 days by the administration of misoprostol, 400 micrograms, orally. Clinical observation for 4 hours followed misoprostol administration. Two weeks later, at a checkup, women were questioned about the abortion experience. Providers also answered questions about acceptability and feasibility. MAIN OUTCOME MEASURES: Patient reports of overall satisfaction with the abortion, the number of women who would choose medical abortion again if needed or recommend the method to others, the best and worst features of the method, and provider and patient assessments of home use. RESULTS: The regimen was highly acceptable. Nearly all women (95.7%) would recommend it to others, 91.2% would choose it again, and 87.6% found it very or moderately satisfactory. Even among women for whom the method failed, 69.6% would try it again, 84.9% would recommend it to others, and 51.9% found it very or moderately satisfactory. The chance to avoid a surgical procedure was reported as the method's best feature. The most commonly cited worst features were the uncertainty and fear of side effects. Providers and women considered home use feasible and safe. CONCLUSIONS: American women found abortion with the use of mifepristone and misoprostol acceptable. Even most with unsuccessful outcomes would select the regimen again and recommend it to others. Most providers and women thought that home use of misoprostol should be available for women who prefer it.

Accuracy of assessment of pregnancy duration by women seeking early abortions.

BACKGROUND: Advances in medical abortion might allow women seeking early abortions to terminate their pregnancies safely and effectively without medical supervision. We investigated whether such women can calculate pregnancy duration accurately, a key step in unsupervised use. METHODS: 422 women seeking first-trimester abortions in two clinics (Pune, India, and Atlanta, USA) used a simple worksheet and calendar to calculate the duration of gestation from the date of last menstrual period (LMP) and/or of unprotected intercourse. Clinicians then used standard clinic practices to estimate pregnancy duration. We compared the two sets of estimates, focusing on women who fell into the "caution zone" (ie, had pregnancy durations >8 weeks according to providers, but < or =8 weeks by their own estimates). FINDINGS: The participants were generally representative of the women seeking abortion at the two clinics. 217 (97.7%) of 222 women in Atlanta and 173 (86.5%) of 200 in Pune could produce an estimate of pregnancy duration. Most (85.4% in Atlanta; 93.6% in Pune) of these estimates were within 2 weeks of those made by providers. For estimates based on LMP, only 10.0% (exact 95% CI 6.2-15.0) of women in Atlanta and 9.8% (5.8-15.3) in Pune fell into the caution zone. For estimates based on a date of intercourse, just 7.7% (4.0-13.1) of women in Atlanta and 3.4% (0-17.8) in Pune fell into the caution zone, although fewer women could use this method. INTERPRETATION: The vast majority of women seeking first-trimester abortion in this study could accurately calculate pregnancy duration within a margin of error clinically inconsequential for safe use of unsupervised medical abortion.

In-depth interviews with medical abortion clients: thoughts on the method and home administration of misoprostol.

OBJECTIVE: To document women's experiences with a home-use mifepristone-misoprostol medical abortion regimen. METHODS: We conducted in-depth interviews (n = 22) with women who received abortions in the New York City clinic of the ongoing Abortion Rights Mobilization clinical trial. Women received 200 micrograms mifepristone in the clinic and were randomized to self-administer 800 micrograms misoprostol vaginally at home either 24, 48, or 72 hours later. One week later, after their follow-up visits, women were asked to describe their experiences in their own words. RESULTS: The overwhelming majority of women found the home-use regimen acceptable. Nearly all said that they would not have preferred to return to the clinic for misoprostol, and many stated that the home-use option was the principal appeal of medical abortion. Women described the medical procedure as "natural," private, and noninvasive, and, when describing their physical experiences, noted that the side effects were more tolerable in the comfort of their homes with someone familiar nearby for support. Additionally, most women felt prepared for the experience they encountered and competent in assessing any problems that arose. CONCLUSION: Home use of misoprostol affords women more flexibility, privacy, and control in their abortions, ultimately allowing them to seek their own comfort level.

Can women in less-developed countries use a simplified medical abortion regimen?

BACKGROUND: Mifepristone-misoprostol abortion, consisting of oral pills, is potentially simple and safe enough for use in less-developed countries. But the labour-intensive, costly, clinic-based European protocols are not affordable or feasible in most less-developed countries. METHODS: We prospectively tested two simplifications to the French mifepristone-misoprostol regimen in Vietnam and Tunisia. Women (n=315) with amenorrhoea 8 weeks or less since their last menstrual period received 200 mg mifepristone in the clinic and then chose whether to take 400 mg oral misoprostol 2 days later either at home or in the clinic. FINDINGS: Despite the two-thirds reduction in mifepristone dose, success rates were high: Vietnam 93%, Tunisia 91%. About 88% of participants chose home administration of misoprostol. Most Vietnamese and Tunisian women were satisfied with their abortions, but efficacy and satisfaction rates were higher among those who used misoprostol at home. INTERPRETATIONS: A simplified medical abortion regimen of 200 mg mifepristone followed by the option of home administration of misoprostol seems feasible.

Mifepristone abortion outside the urban research hospital setting in India.

Medical abortion holds great promise in less-developed countries, where abortion morbidity and mortality remain high. We tested the French mifepristone-misoprostol regimen in two urban outpatient family-planning clinics (n=600) and a rural hospital (n=300) in India. 4% of urban women and 1% of rural women were lost to follow-up. Perfect use and typical-use success rates were as high as European rates at all sites. Although rural women reported fewer side-effects, most women in urban and rural settings were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in urban outpatient clinics and rural hospitals in India.