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-µg 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 β—human chorionic gonadotropin (β-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 β-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 β-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 β-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 β-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.
