RANDOMIZED TRIAL OF MISOPROSTOL AND CERVAGEM IN COMBINATION WITH A REDUCED DOSE OF MIFEPRISTONE FOR INDUCTION OF ABORTION

Mifepristone (600 mg) in combination with a prostaglandin has been demonstrated to be a safe, acceptable alternative to vacuum aspiration for induction of abortion in the first 9 weeks of pregnancy. However, the efficacy and side-effects of different prostaglandins used in combination vith mifepristone have not been assessed in a randomized trial. In this study, 800 women seeking an abortion at gestational age less than or equal to 63 days amenorrhoea were randomized to receive either 0.5 mg gemeprost by vaginal pessary (group I) or 600 mu g misoprostol (group II) by mouth similar to 48 h after taking 200 mg mifepristone by mouth. The side-effects and number of complete abortions were used as measures of efficacy. There was no significant difference in the rate of complete abortion between group I [96.7%; 95% confidence interval (CI) 94.9-98.5%, n = 391] and group II (94.6%; 95% CI 92.3-96,9, n = 386). It was not possible to assess the outcome with certainty in the remaining 23 women. However, there were significantly more ongoing pregnancies in the women who received misoprostol than in those who received gemeprost (nine versus one, P < 0.01) and in eight of these 10 women the gestation was > 49 days, Fewer women in group II required analgesia than in group I (48 versus 60% P < 0.001) although the number requesting opiate was similar in each group (6.9 versus 5.2%, P > 0.4). The incidence of nausea and vomiting after misoprostol (47.8 and 21.9% respectively) was higher (P < 0.001) than after gemeprost (33.9 and 12% respectively). The incidence of infection and heavy bleeding was low in both groups (< 2%) and only one woman required blood transfusion. We conclude that the recommended dose of mifepristone and gemeprost can be reduced without impairing clinical efficacy in pregnancies up to 63 days amenorrhoea. Misoprostol is a safe alternative prostaglandin but has a higher incidence of ongoing pregnancies especially at gestation after 49 days amenorrhoea.