25 mg or 50 mg of Oral Methotrexate Followed by Vaginal Misoprostol 7 Days after for Early Abortion

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Abstract
Background: Several combinations of oral or intravenous methotrexate plus vaginal misoprostol have been used for early abortion with success rates varying widely. So far, any study has evaluated the efficacy and safety of lower doses of oral methotrexate followed by vaginal misoprostol for early abortion. Objectives: To evaluate the efficacy and safety of methotrexate 25 or 50 mg orally and 800 μg of misoprostol vaginally 7 days after the methotrexate for abortion at ≤56 days of gestation. Study Design: Three-hundred and ten pregnant women seeking elective abortion were randomly allocated to receive 25 mg (group I) or 50 mg (group II) of methotrexate orally and 800 μg of misoprostol vaginally 7 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects and vaginal bleeding. Relative risks were used for the comparison between the outcomes from both treatment regimens. Results: In group I aborted 135/148 cases (91%, 95% CI 85, 95%), and 139/154 cases (90%, 95% CI 84, 94%) aborted in group II (relative risk [RR] = 1.01, RR 95% CI 0.94, 1.09). Conclusions: The two treatment regimens showed the same efficacy and safety, so it would be advisable at least to use the smaller methotrexate dose, i.e. 25 mg.

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