Objective. - To compare the safety and efficacy of early abortion by administration of methotrexate and misoprostol vs administration of misoprostol alone. Design. - Randomized controlled trial. Setting. - San Francisco (Calif) General Hospital. Patients. - Pregnant women at 56 days' gestation or less seeking elective abortion. Sixty-three women volunteered for the trial; 61 completed the study and are included in the analysis. Intervention. - Intramuscular administration of 50 mg of methotrexate per square meter of body surface area followed 3 days later by vaginal administration of 800 μg of misoprostol (group 1) or the same dose of misoprostol given alone (group 2). The misoprostol dose was repeated 24 hours later if abortion had not occurred. Main Outcome Measures. - Successful abortion, duration of vaginal bleeding, side effects, and change in β-human chorionic gonadotropin (β-hCG) level. An abortion was considered successful if the pregnancy ended without requiring a surgical procedure. Results. - Complete abortion occurred in 28 (90%) of 31 patients in group 1 and 14 (47%) of 30 patients in group 2 (P<.001). Seventeen (61%) of the 28 women in group 1 who aborted did so the same day as misoprostol administration; vaginal bleeding lasted a mean (±SD) of 10 (±4) days, and β-hCG level was less than or equal to 10 IU/L by a mean of 31 (±6) days after methotrexate administration. The 11 other women in group 1 who aborted did so after a mean delay of 29 (±11) days; vaginal bleeding lasted 7 (±4) days, and β-hCG level was less than or equal to 10 IU/L by a mean of 24 (±11) days after the abortion. There were three treatment failures in group 1: two ongoing pregnancies (6%) and one incomplete abortion (3%). For the 14 women with successful abortions in group 2, vaginal bleeding lasted a mean of 10 (±6) days and β-hCG level was less than or equal to 10 IU/L by a mean of 39 (±18) days after the misoprostol. There were 16 treatment failures in group 2: eight ongoing pregnancies (27%), and eight incomplete abortions (27%). Methotrexate side effects were minimal. Misoprostol side effects were diarrhea in 18% and nausea and vomiting in 5%. Conclusions. - Methotrexate and vaginal misoprostol are more effective than misoprostol alone. Both drugs are available throughout the United States, and both drugs are inexpensive. This combination may offer an alternative to the use of antiprogestin and prostaglandin for medical abortion.
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