Résumé : The safety and effectiveness of oral methotrexate and vaginal misoprostol for early abortion were evaluated in a prospective study of 300 women who presented to the Cuidad de la Habana (Havana, Cuba) for termination of a pregnancy of a gestational age of 63 days or less. All women were given 50 mg of methotrexate at study entry and then were randomly allocated to receive 800 mcg of misoprostol either 3, 4, or 5 days later. If abortion did not occur, misoprostol was readministered 48 and 96 hours later. Complete abortion occurred in 273 women (91%); the success rate was 72% (216 cases) after just one dose of misoprostol. There were no significant differences in abortion rates based on the day on which misoprostol was administered. Vaginal bleeding lasted an average of 7.1 +or- 3.8 days, spotting continued for 4.1 +or- 2.5 days, and total bleeding persisted for 11.2 +or- 4.1 days. Side effects for methotrexate included nausea (9.7%), vomiting (6.7%), dizziness (10.3%), fatigue (6.3%), headache (5.3%), and chills (5.3%). For misoprostol, side effects included nausea (23.0%), vomiting (25.3%), diarrhea (51.7%), dizziness (18.3%), headache (18.0%), chills (60.0%), and pelvic pain (97.3%). All signs and symptoms were of low intensity and short duration, however. These results suggest that combined use of methotrexate and misoprostol represents a feasible alternative to the intramuscular use of methotrexate or of antiprogestins and prostaglandin for medical abortion. The efficacy and safety of this new regimen are very close to those of RU-486, but the cost is considerably less.
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