Objective: To evaluate the safety and efficacy of oral methotrexate an
d vaginal misoprostol for medical abortion. Methods: A prospective mul
ticenter trial involved 300 women up to 49 days' gestation seeking ele
ctive abortion. Subjects received methotrexate 50 mg orally followed 5
-6 days later by misoprostol 800 mu g vaginally. The misoprostol dose
was repeated if abortion did not occur. Results: Complete abortion occ
urred in 273 of 299 women (91.3%; 95% confidence interval [CI] 87.5, 9
4.2%); one woman was lost to follow-up. Abortion occurred within 8 day
s of the methotrexate in 233 women (77.9%; 95% CI 72.8, 82.5%); the re
maining 13.4% of women who aborted did so after a delay of 23.5 +/- 9.
8 days (median 23 days, range 10-45). Vaginal bleeding lasted an avera
ge of 15 and 11 days in immediate and delayed-success abortions, respe
ctively. Complete abortion rates decreased linearly with increasing bo
dy surface area. After methotrexate and misoprostol administration, na
usea was reported in 37% and 33%, vomiting in 11% and 18%, diarrhea in
12% and 18%, and subjective fever or chills in 15% and 31% of subject
s, respectively. Conclusion: Oral methotrexate followed by vaginal mis
oprostol is effective for abortion and represents an acceptable altern
ative to intramuscular methotrexate in regimens for medical abortion.
(C) 1997 by The American College of Obstetricians and Gynecologists.