Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: A comparative trial of mifepristone-misoprostol versus surgical abortion,☆☆,,★★

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Abstract

OBJECTIVE: We investigated safety, efficacy, and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries.

STUDY DESIGN: Women (n = 1373) with amenorrhea ≤56 days chose either surgical abortion (as provided routinely) or 600 mg of mifepristone followed after 48 hours by 400 μg of misoprostol. This is the appropriate design for studying safety, efficacy, and acceptability among women selecting medical abortion over available surgical services.

RESULTS: The medical regimen had more side effects, particularly bleeding, than did surgical abortion but very few serious side effects. Failure rates for medical abortion, although low, exceeded those for surgical abortion: 8.6% versus 0.4% (China), 16.0% versus 4.0% (Cuba), and 5.2% versus 0% (India). Nearly half of failures among medical clients were not true drug failures, however, but surgical interventions not medically necessary (acceptability failures or misdiagnoses). Women were satisfied with either method, but more preferred medical abortion.

CONCLUSION: Medical abortion can be safe, efficacious, and acceptable in developing countries.(Am J Obstet Gynecol 1997;176:431-7.)

Section snippets

Study design

Randomized, controlled trials are traditionally used to investigate efficacy and safety of new therapies. In our trial, however, we chose a different design, intended to capture important data on acceptability. Acceptability is not only important as a measure of whether a new technique will be well received in a culture, but in the case of medical abortion, the patient must be prepared and willing to undergo an entirely different treatment if she wishes to avoid surgery. Because medical

Enrollment and method selection

The sample included 1373 women: 567 in China, 499 in Cuba, and 307 in India. Although the study design called for equal numbers of medical and surgical patients (China 300 each, Cuba 250 each, India 250 each), more eligible participants chose medical abortion from the beginning. Chinese investigators handled the imbalance by enrolling many women requesting IUDs into the surgical arm of the study. (Investigators in all three countries admitted at least some patients citing immediate IUD

Comment

This study provides clear evidence that medical abortion techniques are safe, efficacious, and desirable to many women outside Europe and North America. When given information on both methods and then offered a choice between medical and surgical abortion, most women in all three sites selected the medical regimen. Fewer than 1% requested assignment to a method, belying a belief that women cannot choose between abortion techniques.

Across all sites and measures, medical abortion has a higher

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From the Population Council,a the Department of Obstetrics and Gynaecology, K.E.M. Hospital,b Jefe Nacional de Obstetricia y Ginecologia, Ministerio de Salud Publica,c the National Research Institute for Family Planning,d the Beijing Municipal Research Institute for Family Planning,e the Department of Family Planning, Gynecological and Obstetrical Hospital, Shanghai Medical University,f and the Clinic for Women, Bhatia General Hospital.g

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Supported by The Population Council, a nonprofit, nongovernmental research organization.

Reprint requests: Beverly Winikoff, MD, The Population Council, One Dag Hammarskjold Plaza, New York, NY 10017.

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