The purpose of this study was to compare the outcome and side effects of using the drugs methotrexate and misoprostol, alone or in combination, to induce abortion. A total of 108 subjects who had requested elective termination of pregnancy and medical abortion at 9 weeks gestation or less were randomized into three groups. The first group received 50 mg/m2 intramuscular (i.m.) methotrexate on day 1 and, if the hCG level had risen by > 50% of the initial level on day 4, a second dose was given. They were then followed-up at weekly intervals up to day 21. Group 2 received 800 micrograms vaginal misoprostol on day 1 and, if ultrasound showed a gestational sac on day 4, they received a repeat dose and were re-examined on day 7. Group 3 received 50 mg/m2 methotrexate intramuscularly followed 3 days later by 800 micrograms vaginal misoprostol and were re-examined on day 7. Complete abortion occurred in 25 (69%) of the 36 subjects in group 1, 21 (58%) of the 36 subjects in group 2, and 32 (89%) of the 36 subjects in group 3. The complete abortion rate in group 3 was significantly higher than that of both group 1 and group 2 (p < 0.05). The incomplete abortion rate was significantly higher in group 2 as compared with both of the other groups (p < 0.05). There were significant differences between the mean gestational age of the successful abortions and the failures in group 1 (no abortion occurred at more than 49 days gestation), but not in groups 2 or 3. Vaginal bleeding in subjects who successfully aborted began within 16 +/- 4 days in group 1 after the first dose, and within 24 h in 18 (86%) of the 21 subjects in group 2 and 27 (84%) of the 32 subjects in group 3 after the misoprostol dose. The drugs caused no serious or prolonged side effects. The combination of methotrexate and misoprostol is a more effective abortifacient regimen than when either drug is used alone.
PIP: A randomized controlled study was performed to assess the efficacy of intramuscular (im) methotrexate and vaginal misoprostol, either alone or in combination, for abortion among 108 women at 63 days¿ gestation or less. The subjects were those who had requested elective termination of pregnancy and medical abortion at 9 weeks¿ gestation or less and were randomized into three groups. Group 1 took 50 mg/sq. m im methotrexate on day 1 and a second dose was given if the human chorionic gonadotropin level had increased by 50% of the initial level on day 4. Weekly intervals were done until day 21. Group 2 took 800 mcg vaginal misoprostol on day 1 and a repeat dose was given if ultrasound showed a gestational sac on day 4. Reexamination was done on day 7. Group 3 took 50 mg/sq. m im methotrexate, which was followed 3 days later by 800 mcg vaginal misoprostol; subjects were reexamined on day 7. In group 1, complete abortion occurred in 69% of the subjects; in group 2, in 58% of the subjects; in group 3, in 89% of the subjects. Complete abortion rate was higher in group 3 than in groups 1 and 2. Therefore, the combination of methotrexate and misoprostol is a more effective abortifacient regimen than either drug is alone.