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Comparison of misoprostol‐only and combined mifepristone–misoprostol regimens for home‐based early medical abortion in Tunisia and Vietnam
Author(s) -
Blum Jennifer,
Raghavan Sheila,
Dabash Rasha,
Ngoc Nguyen thi Nhu,
Chelli Héla,
Hajri Selma,
Conkling Kathryn,
Winikoff Beverly
Publication year - 2012
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2012.03.039
Subject(s) - misoprostol , mifepristone , medicine , medical abortion , obstetrics , abortion , placebo , abortifacient , gynecology , pregnancy , genetics , alternative medicine , pathology , biology
Objective To assess the potential advantages of combined mifepristone–misoprostol versus misoprostol‐only for early medical abortion. Methods A double‐blind randomized placebo controlled study was conducted that enrolled 441 pregnant women (< 63 days since last menstrual period) at 2 hospitals in Tunisia and Vietnam. The mifepristone–misoprostol group (n = 220) received 200 mg of mifepristone on day 1 and 800 μg buccal misoprostol followed by placebo 3 hours later on day 2. The misoprostol‐only group (n = 221) received placebo on day 1 and 1600 μg of misoprostol (2 doses of 800 μg, given 3 hours apart) on day 2. All medications were self‐administered at home with follow‐up 1 week later. The primary outcome was complete uterine evacuation without surgical intervention. Results Successful uterine evacuation occurred for 78.0% (n = 170) of women with misoprostol only versus 92.9% (n = 195) of women with mifepristone–misoprostol (relative risk 0.84, 95% CI, 0.78–0.91; P < 0.001). Ongoing pregnancy occurred for 13.8% (n = 30) of women given misoprostol‐only and 1.4% (n = 3) of women given mifepristone–misoprostol (relative risk 9.63, 95% CI 2.98–31.09; P < 0.001). Conclusion Mifepristone plus misoprostol is significantly more effective than misoprostol‐only for early medical abortion. Clinical trials.gov registration number: NCT00680394 .