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Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion: A Randomized Controlled Trial

Winikoff, Beverly MD, MPH1; Dzuba, Ilana G. MHS1; Creinin, Mitchell D. MD2; Crowden, William A.3; Goldberg, Alisa B. MD, MPH4; Gonzales, Juliana5; Howe, Michelle PA-C6; Moskowitz, Jeffrey MD7; Prine, Linda MD8; Shannon, Caitlin S. JD, MPH1

doi: 10.1097/AOG.0b013e31818d8eb4
Original Research

OBJECTIVE: To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP).

METHODS: This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24–36 hours after mifepristone 200 mg with 7–14-day follow-up.

RESULTS: Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92–0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24–11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57–63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82–0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0–20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods.

CONCLUSION: Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867

LEVEL OF EVIDENCE: I

Buccal administration of misoprostol 800 mcg after mifepristone 200 mg is a safe and highly effective option for pregnancy termination through 63 days since the last menstrual period.

From the 1Gynuity Health Projects, New York, New York; 2Magee Womens Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania; 3Planned Parenthood of Waco, Waco, Texas; 4Planned Parenthood League of Massachusetts, Boston, Massachusetts; 5Whole Woman’s Health, Austin, Texas; 6Family Planning Associates Medical Group, Chicago, Illinois; 7Parkmed, New York, New York; and 8Institute for Urban Family Health, New York, New York.

Funds to carry out this study were provided by an anonymous donor.

The authors thank Thomas F. Britton, MD, Michael Molaei, MD, Robert Hanson, MD, and E. Steve Lichtenberg, MD, MPH, for clinical oversight of their respective study sites and Dr. Lichtenberg for his support in the design of the study and revision of the manuscript.

Presented at the National Abortion Federation’s Annual Meeting, Boston, MA, April 21–24, 2007; Reproductive Health 2007, Minneapolis, MN, September 26–29, 2007, and the 10th Congress of the European Society of Contraception, Prague, Czech Republic, April 30 to May 3, 2008.

Corresponding author: Ilana G. Dzuba, Gynuity Health Projects, 15 E. 26th Street, Suite 801, New York, NY 10010; e-mail: idzuba@gynuity.org.

Financial Disclosure Dr. Winkoff, Ms. Dzuba, and Ms. Shannon are all with Gynuity Health Projects (New York, NY), who had a contract with Danco Laboratories, the distributor of mifepristone in the United States, to carry out Phase IV studies that are a part of Danco’s responsibility to the U.S. Food and Drug Administration. Dr. Creinin has received compensation from Danco Laboratories, LLC, for providing third-party telephone consultations to clinicians who seek expert advice on mifepristone. The other authors have no potential conflicts of interest to disclose.

© 2008 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.