Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam

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. © 2012 International Federation of Gynecology and Obstetrics.