OBJECTIVE: To demonstrate equivalence between mifepristone 200 mg followed 6 to 8 hours later and 24 hours later by misoprostol 800 μg vaginally for abortion in women up to 63 days of gestation.
METHODS: Mifepristone 200 mg was swallowed by 1,080 women after which they were randomly assigned to self-administer misoprostol intravaginally 6 to 8 hours later (group 1) or 23 to 25 hours later (group 2) at home. Participants returned for an evaluation, including transvaginal ultrasonography, 7 ± 1 days after initiating treatment. Subjects who had not aborted were offered a second dose of misoprostol. All participants returned approximately 2 weeks after receiving mifepristone. Telephone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication.
RESULTS: Complete abortion rates for groups 1 and 2 were 503 of 525 (95.8%, 95% confidence interval 93.7%, 97.3%) and 521 of 531 (98.1%, 95% confidence interval 96.6%, 99.1%), respectively, which were statistically equivalent. Side effects were significantly more common after mifepristone administration for women in group 2. Nausea, vomiting, and heavy bleeding were also significantly greater for women in group 2 after misoprostol treatment. Pain and subject acceptability were similar between groups.
CONCLUSION: Mifepristone 200 mg followed 6 to 8 hours later by misoprostol 800 μg vaginally is as effective for abortion and has significantly fewer side effects as compared with regimens using a 24-hour dosing interval. Women receiving mifepristone and vaginal misoprostol for abortion can have the flexibility to administer the misoprostol as soon as 6 hours after using the mifepristone.
LEVEL OF EVIDENCE: I
Mifepristone and vaginal misoprostol can be administered on the same day for medical abortion with high efficacy and low rates of side effects.
From the *Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine and Magee–Womens Research Institute, Pittsburgh, Pennsylvania; †Department of Obstetrics and Gynecology, Columbia University, New York, New York; ‡Department of Obstetrics and Gynecology, Boston University, Boston, Massachusetts; and §Department of Family Medicine, University of Rochester, Rochester, New York.
*For participants in the MOD Study Trial Group, see the Appendix.
Supported by an anonymous foundation.
Reprints are not available. Address correspondence to: Mitchell D. Creinin, MD, University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA 15213–3180; e-mail: email@example.com.
Received December 1, 2003. Received in revised form January 23, 2004. Accepted January 28, 2004.