Combined methotrexate and misoprostol for early induced abortion.
OBJECTIVE: To determine the effectiveness and side effects of and subject satisfaction with an induced abortion by administration of methotrexate and intravaginal misoprostol. SUBJECTS AND DESIGN: Prospective trial of 100 consecutive pregnant women aged 18 years or older at 8 weeks' gestation or less and wanting an abortion. INTERVENTIONS: Intramuscular administration of 50 mg of methotrexate per square meter of body surface area on day 1 and a misoprostol 800-micrograms vaginal suppository on day 3. Administration of misoprostol was repeated the following day if no bleeding occurred after the first dose. PROTOCOL: After pregnancy dating by clinical criteria, subjects were followed up with serum beta-human chorionic gonadotropin (beta-hCG) determinations on days 1, 7, and 14 and a high-sensitivity urine hCG test every 2 weeks until the value was less than 10 IU/L. Subjects completed a daily symptom log and satisfaction questionnaire on day 14. MAIN OUTCOME MEASURES: Complete abortion as defined by vaginal bleeding and a beta-hCG value of less than 10 IU/L without surgical intervention, complications and side effects, and patient satisfaction. RESULTS: Ninety-seven subjects had a complete abortion and one subject had vaginal bleeding and a 94% decrease of her beta-hCG value on day 7 but was subsequently unavailable for follow-up. Two subjects required surgical procedures: one with a continued pregnancy and one for excessive bleeding. No failures or complications occurred in early gestations prior to 45 days from the last menstrual period. Seventy-three percent responded to misoprostol treatment with bleeding within 12 hours and had a mean decrease of 90% in their beta-hCG value on day 7. Twenty-seven percent had no immediate bleeding response to misoprostol administration, began bleeding on day 10 (SD, 8 days), and had a mean decrease of 10% in their beta-hCG value on day 7. Seventy percent reported nausea; 46%, diarrhea; and 23%, vomiting. Ninety-three percent agreed that the procedure was acceptable and 95% would recommend the procedure. CONCLUSIONS: Methotrexate and misoprostol were effective in inducing an abortion up to 8 weeks. Home administration of a compounded misoprostol vaginal suppository was successful. Although gastrointestinal tract side effects were common, women found the procedure and its side effects acceptable.