Early Medical Abortion With Mifepristone (RU 486) And Misoprostol Is Highly Acceptable To American Women

July 15, 1998

NEW YORK (July 15, 1998)--Over 2,000 American women, pregnant for 63 days or less, who underwent medical abortion with mifepristone (formerly called RU 486) and misoprostol, found the method highly acceptable. Nearly all (96 percent) would recommend it to others; 91 percent would choose it again; and 88 percent found it very or moderately satisfactory. Even among women for whom the method failed, 70 percent would try it again; 85 percent would recommend it to others; and 52 percent found it very or moderately satisfactory.

These results of acceptability of mifepristone-misoprostol for early medical abortion are reported in the July/August issue of Archives of Family Medicine. Safety and efficacy data from the same large, multicenter clinical trial conducted by the Population Council were published in the April 30, 1998 issue of the New England Journal of Medicine. That article concluded the method was safe and highly effective, particularly within the first 49 days of a pregnancy.

"Our trial results accord with previous research findings that early medical abortion is desirable to the women who choose it," said Beverly Winikoff, M.D., lead author of the study. "Despite socioeconomic or cultural differences, views of the participants in this trial resonate with those of women living in various regions of the world. Indeed, much as in previous medical abortion acceptability studies conducted in other parts of the world, when asked why they had chosen medical abortion, women in this study assigned great importance to avoiding invasive surgical procedures and to an experiential quality of the method that women consider natural."

Trial Protocol

The 2,121 women followed the oral regimen of mifepristone-misoprostol that is standard in France. Women with pregnancy durations of 63 days or less swallowed 600 mg of mifepristone at their first clinic visit. Two days later, they took 400 mcg. of misoprostol orally and were observed for 4 hours. At a final visit 12 days later, each patient's pregnancy status was assessed, and patients answered several questions about acceptability. As part of an investigator's questionnaire, providers assessed the potential for the safe home use of mifepristone-misoprostol for each study participant. The clinical trial took place at 17 clinics in 15 states; the sites included Planned Parenthood affiliates, university hospitals, and free-standing clinics. The sample included African-American, Asian, Caucasian, and Hispanic women. Focus groups with providers also were conducted at all participating clinics. "For a new technology to be a viable option in a health care system," Winikoff et al. say, "both patients and providers need to want to use it and to ask for it. For this reason, understanding how women and medical personnel perceive and value a new technology is important. In the case of medical abortion, however, patient acceptability is also key to the success of the method. Indeed, surgical intervention rates are influenced by patients' attitudes, expectations, and tolerance of adverse effects, and by physicians', nurses', and counselors' understanding and aptitude for using the method. For medical methods of abortion to work successfully, women must feel committed to completing the regimen, and both women and providers must wait while the therapy takes its course."

Success rates in the trial varied by gestational age. Among women with pregnancies of 49 days' duration or less since their last menstrual period, 92 percent had successful medical abortions. These results are similar to the French experience. Efficacy declined with increasing gestational age. The most prevalent side effects were similar to those experienced with spontaneous abortion: cramping and bleeding. Many women also had gastrointestinal side effects, particularly nausea, vomiting, and diarrhea. About a third of the women reported headaches at some point during the two-week observation period. Serious side effects were rare. Women received surgical interventions when requested, when the drugs failed to terminate the pregnancy completely, when women did not want to wait for the medical abortion to occur, or when intervention appeared medically needed.

What Women Liked and Disliked about the Method

At enrollment, the most frequently cited reasons for opting for medical over surgical abortion was that it allowed women to avoid an operation and was noninvasive, and that it seemed natural, like a miscarriage or menses. Other reasons given included favorable features of the study, such as good medical care, no insurance problems, and that it was free; that the method was safe, with a low risk of complications and side effects; and that it seemed easier, simpler, or faster. Some participants voiced a political commitment to abortion rights and availability of mifepristone in the United States, while others had had a previous bad experience with surgical abortion. Although almost all the women felt the method had been adequately explained through counseling, almost half of them said their experience had differed from what they had expected. Two-thirds of these women felt the experience was better than expected, while one-third thought it was worse. Not unexpectedly, successful users were more likely than others to classify the experience as better than expected. More than three-quarters of the women who had had a previous surgical abortion--about half of the total sample of women--said medical abortion was more satisfactory than their earlier experience. Even among patients who had method failures, 45 percent felt the failed medical abortion had been more satisfactory than their previous surgical abortion, while 37 percent found the experience less satisfactory.

At the final visit, women were asked to describe the best and worst features of the method. The most commonly cited positive attributes were no surgery and/or injections, noninvasive; natural, feminine, like menses or miscarriage; less pain; easier emotionally, less frightening; and easier, simpler, or faster. The most commonly cited worst features related to feared as well as actual difficulties (in fact, many women did not distinguish between feared and actual side effects): pain or cramping; waiting, uncertainty, or fear of the unknown; and feared or actual nausea, vomiting, or diarrhea. Yet, 22 percent of the women said there had been no worst features at all.

Feasibility of Home Administration

Over two-thirds of successful abortions took place during the four hours women were asked to wait in the clinic, while 22 percent occurred at home and the rest elsewhere. Few women who had successful abortions at home or at the clinic were troubled by the time or place of expulsion, but some women reported difficulties when expulsions occurred elsewhere. Some women also found it difficult to manage the three visits required by the trial regimen, citing work commitments, transportation, school obligations, and child care needs.

Study data also suggest that the option of a less medically supervised regimen may be desirable: Both women and providers endorsed the feasibility of home administration of both mifepristone and misoprostol. Nearly all providers thought that most women could safely have used the method at home. Women felt similarly, although they were less comfortable with the prospect of taking misoprostol at home than mifepristone.(Preliminary results from an ongoing multisite study allowing home administration of misoprostol, however, indicate that most women find this option highly acceptable.)

"If misoprostol is used at home, specific counseling about what to expect in the hours after self-administration and the availability of a 24-hour telephone support line may help allay women's concerns," Dr. Winikoff said. Those women who would prefer to have their medical abortions in the clinic ideally should have a choice over the degree of medical supervision involved. Additionally, the results of focus groups conducted with 78 providers from this study show that generally they liked offering women a choice of methods. Even those providers who were initially skeptical about medical abortion grew to like the method; by the end of the study, 62 percent of the providers in the focus groups reported they would choose mifepristone medical abortion themselves if needed.
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"Acceptability and Feasibility of Early Pregnancy Termination by Mifepristone-Misoprostol." Beverly Winikoff, M.D., M.P.H., Charlotte Ellertson, Ph.D., Batya Elul, M.Sc., Irving Sivin, M.A. for the Mifepristone Clinical Trials Group. Archives of Family Medicine, 1998; 7:360-366.

"The safety and efficacy of early pregnancy termination with mifepristone and misoprostol: results from the first multicenter U.S. trial." Irving Spitz, M.D., Lauri Benton, M.D. Wayne Bardin, M.D., and Ann Robbins, Ph.D. New England Journal of Medicine 1998; 338:1241-1247.

For a summary of Highlights of the mifepristone clinical trial and related information, visit the Population Council's website: http://www.popcouncil.org. Click on programs and research, then on reproductive health products/clinical trials of mifepristone in the U.S.
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Population Council

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