Methotrexate and misoprostol used alone or in combination for early abortion

The purpose of this study was to compare the outcome and side effects of us ing the drugs methotrexate and misoprostol, alone or in combination, to ind uce abortion. A total of 108 subjects who had requested elective terminatio n elf pregnancy and medical abortion at 9 weeks gestation or less were rand omized into three groups. The first group received 50 mg/m(2) intramuscular (IM) 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 mu g vaginal misopr ostol on day 2 and, if ultrasound showed a gestational sac on day 4, they r eceived a repeat dose and were re-examined on day 7. Group 3 received 50 mg /mg(2) methotrexate intramuscularly followed 3 days later by 800 mu g vagin al misoprostol and were re-examined on day 7. Complete abortion occurred in 25 (69%) of the 36 subjects in group 2, 22 (58%) of the 36 subjects in gro up 2, and 32 (89%) of the 36 subjects in group 3. The complete abortion rat e in group 3 was significantly higher than that of both group I 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 signifi cant differences between the mean gestational age of the successful abortio ns and the failures in group 2 (no abortion occurred at more than 49 days g estation), but not in groups 2 or 3. Vaginal bleeding in subjects who succe ssfully 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 miso prostol is a more effective abortifacient regimen than when either drug is used alone. (C) 1999 Elsevier Science Inc. All rights reserved.