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Obstetrics & Gynecology 2007;109:885-894
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion

A Randomized Controlled Trial

Mitchell D. Creinin, MD1,2, Courtney A. Schreiber, MD, MPH1, Paula Bednarek, MD, MPH3, Hanna Lintu, MD, MPH4, Marie-Soleil Wagner, MD, MS5, Leslie A. Meyn, MS1 for the Medical Abortion at the Same Time (MAST) Study Trial Group*

From the 1Department of Obstetrics, Gynecology and Reproductive Sciences and Magee-Womens Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; 2Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania; 3Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon; 4Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and 5Department of Obstetrics and Gynecology, University of Southern California, Los Angeles, California.

OBJECTIVE: Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation.

METHODS: The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7±1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication.

RESULTS: The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0–96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1–98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1.

CONCLUSION: Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568

LEVEL OF EVIDENCE: I






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