OBJECTIVES: This study examined the effectiveness of an abortion by methotrexate and misoprostol, including side effects, subjects' satisfaction, and optimal treatment strategies. METHODS: The study evaluated a prospective ongoing trial of women with an 8-week gestation or less wanting an abortion. Subjects received intramuscular methotrexate (50 mg per m2 of body surface area) on day 1. Subjects self-administered misoprostol 800 micrograms orally or as a vaginal suppository or vaginal tablets either on day 3 to 4 or day 5 to 7. Repeat misoprostol 800 micrograms doses were used vaginally if there was no significant bleeding and the gestation was less than 12 weeks. Subjects with continuing pregnancies had a surgical abortion. Subjects completed a daily symptom log and a satisfaction questionnaire. A successful medical abortion was defined by vaginal bleeding without surgical intervention and either a negative urine pregnancy test or a negative transvaginal ultrasound. RESULTS: Of the 282 subjects, 274 (97%) had a medical abortion. Eight (3%) subjects required surgical intervention--four for continued pregnancies and four for excessive bleeding. One hundred and sixty-two (57%) subjects required only one dose of misoprostol and started bleeding, on average, 6.2 hours later. One hundred and twelve subjects (40%) required an average of 2.5 misoprostol doses and started bleeding, on average, 12.4 days after initial methotrexate injection. Misoprostol was more effective vaginally than orally. Gastrointestinal side effects were common, mild, and brief. Eighty-eight percent of the subjects agreed that the procedure went well. Subjects monitored with ultrasound completed the study sooner than those followed by beta-hCG levels. CONCLUSION:Methotrexate and misoprostol were effective in inducing an abortion up to 8 weeks' gestation. The procedure is a promising alternative to surgical abortion.
RCT Entities:
OBJECTIVES: This study examined the effectiveness of an abortion by methotrexate and misoprostol, including side effects, subjects' satisfaction, and optimal treatment strategies. METHODS: The study evaluated a prospective ongoing trial of women with an 8-week gestation or less wanting an abortion. Subjects received intramuscular methotrexate (50 mg per m2 of body surface area) on day 1. Subjects self-administered misoprostol 800 micrograms orally or as a vaginal suppository or vaginal tablets either on day 3 to 4 or day 5 to 7. Repeat misoprostol 800 micrograms doses were used vaginally if there was no significant bleeding and the gestation was less than 12 weeks. Subjects with continuing pregnancies had a surgical abortion. Subjects completed a daily symptom log and a satisfaction questionnaire. A successful medical abortion was defined by vaginal bleeding without surgical intervention and either a negative urine pregnancy test or a negative transvaginal ultrasound. RESULTS: Of the 282 subjects, 274 (97%) had a medical abortion. Eight (3%) subjects required surgical intervention--four for continued pregnancies and four for excessive bleeding. One hundred and sixty-two (57%) subjects required only one dose of misoprostol and started bleeding, on average, 6.2 hours later. One hundred and twelve subjects (40%) required an average of 2.5 misoprostol doses and started bleeding, on average, 12.4 days after initial methotrexate injection. Misoprostol was more effective vaginally than orally. Gastrointestinal side effects were common, mild, and brief. Eighty-eight percent of the subjects agreed that the procedure went well. Subjects monitored with ultrasound completed the study sooner than those followed by beta-hCG levels. CONCLUSION:Methotrexate and misoprostol were effective in inducing an abortion up to 8 weeks' gestation. The procedure is a promising alternative to surgical abortion.