A prospective trial including 300 pregnant women seeking elective abor
tion was conducted to evaluate the safety and efficacy of methotrexate
and misoprostol for abortion at less than or equal to 63 days' gestat
ion. Subjects received methotrexate 50 mg orally and were randomly all
ocated to receive 800 mu g of misoprostol vaginally 3, 4, or 5 days af
ter administration of the methotrexate. The misoprostol dose was repea
ted 48 and 96 h later if abortion did not occur. Outcome measures incl
uded successful abortion (complete abortion without requiring a surgic
al procedure) and side effects. Complete abortion occurred in 273 of 3
00 patients (91%, 95% CI 87, 94%) patients. No significant statistical
differences were found in the success rates when misoprostol was give
n days 3, 4, or 5 after the administration of methotrexate IP = 0.69).
Vaginal bleeding lasted 7.1 +/- 3.8 days, spotting 4.1 +/- 2.5 days,
and total bleeding 11.2 +/- 4.1 days. Side effects for methotrexate we
re minimal, whereas, for misoprostol they were mild and transient exce
pt for pain. The use of methotrexate and misoprostol together could he
an alternative to the intramuscular use of methotrexate or the use of
antiprogestins and prostaglandin for medical abortion. (C) 1998 Elsev
ier Science Inc. All rights reserved.