MISOPROSTOL-3, MISOPROSTOL-4, OR MISOPROSTOL-5 DAYS AFTER METHOTREXATE FOR EARLY ABORTION - A RANDOMIZED TRIAL

A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, o r 5 days after methotrexate for abortion at less than or equal to 63 d ays' gestation. Subjects received 50 mg/m(2) methotrexate intramuscula rly and were randomly allocated to self-administer vaginally 800 mu g of misoprostol 3, 4, or 5 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Ou tcome measures included successful abortion (complete abortion without requiring a surgical procedure), and side effects. Eighty-six cases ( 93%; 95% confidence interval [CI] 85%-97%) aborted in Group I; 90 case s (92%; 95% CI 84%-96%) aborted in Group II (relative risk [RR] = 1.09 ; RR 95% CI 0.38-3.14); and 89 (93%; 95% CI 86%-97%) cases aborted in Group III (RR = 0.97; RR 95% CI 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0. 97) nor with any of the characteristics oi the subjects. Complete abor tion occurred in 265/287 (92%; 95% CI 89%-95%) patients. Twenty-two ca ses (8%; 95% CI 5%-11%) resulted in failure. Side effects for methotre xate were minimal while for misoprostol they were moderate. This combi nation could be an alternative to surgical abortion or the use of anti progestins and prostaglandins for medical abortion. (C) 1997 Elsevier Science Inc. All rights reserved.