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Multicenter Trial of a Simplified Mifepristone Medical Abortion Regimen

Caitlin S. Shannon, MPH^*, Beverly Winikoff, MD, MPH^*, Richard Hausknecht, MD, Eric Schaff, MD, Paul D. Blumenthal, MD, Deborah Oyer, MD^¶, Heather Sankey, MD^||, Jessica Wolff, NP^|| and Rachel Goldberg, MPH^*

From the *Gynuity Health Projects, New York, New York; The Mount Sinai School of Medicine, New York, New York; Reproductive Health Program Research Clinic, Rochester, New York; Johns Hopkins Bayview Medical Center, Baltimore, Maryland; ¶Aurora Medical Services, Seattle, Washington; and ||Planned Parenthood League of Massachusetts, Springfield, Massachusetts.

OBJECTIVE: To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 µg oral misoprostol

METHODS: The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 µg misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study

RESULTS: Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory

CONCLUSION: A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 µg oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration.

LEVEL OF EVIDENCE: III