Human Reproduction, Vol. 17, No. 6, 1477-1482,
June 2002
© 2002 European Society of Human Reproduction and Embryology
A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy
1 Department of Obstetrics and Gynecology, University of Southern California Keck School of Medicine, Women's and Children's Hospital, Los Angeles, CA 90033, 2 Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee–Women's Hospital, Pittsburgh, PA 15213 and 3 Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco General Hospital, San Francisco, CA 94110, USA
BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 250 women with gestations 
56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 µg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05). CONCLUSIONS: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available.
Key words: abortion/medical abortion/mifepristone/misoprostol/pregnancy
4 To whom correspondence should be addressed at: 1240 N. Mission Rd, room 8K9, Los Angeles, CA 90033, USA.E-mail: jjain{at}hsc.usc.edu
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