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  • Title: Randomized trial of misoprostol and cervagem in combination with a reduced dose of mifepristone for induction of abortion.
    Author: Baird DT, Sukcharoen N, Thong KJ.
    Journal: Hum Reprod; 1995 Jun; 10(6):1521-7. PubMed ID: 7593528.
    Abstract:
    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 with mifepristone have not been assessed in a randomized trial. In this study, 800 women seeking an abortion at gestational age < or = 63 days amenorrhoea were randomized to receive either 0.5 mg gemeprost by vaginal pessary (group I) or 600 micrograms misoprostol (group II) by mouth approximately 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).(ABSTRACT TRUNCATED AT 250 WORDS) To assess the efficacy and side-effects of different prostaglandins used in mifepristone-induced abortion, 800 women were randomly assigned to receive 0.5 mg of gemeprost by vaginal pessary or 600 mcg of oral misoprostol 48 hours after oral administration of 200 mg of mifepristone. The subjects, all of whom were at gestational age 63 days or under, were referred by local family planning clinics to the Royal Infirmary of Edinburgh (Scotland). Fetal tissue or placenta was expelled within four hours after prostaglandin administration in 53.5% of women in the gemeprost group and 55.8% of those in the misoprostol group; the complete abortion rates were 96.7% and 94.6%, respectively. There was one ongoing pregnancy in the former group compared to nine in the latter group--a finding consistent with previous reports of a higher failure rate for misoprostol than gemeprost--and in eight of these women, the gestational age exceeded 49 days. The two major side-effects--nausea and vomiting--were more common in the misoprostol group (47.8% and 21.9%, respectively) than in the gemeprost group (33.5% and 12.0%, respectively). The authors' previous research had indicated there is no difference in clinical efficacy between 200 mg and 600 mg (standard dose) of mifepristone in combination with 600 mcg of misoprostol. This study confirms the efficacy of the lower dose of mifepristone and further indicates the feasibility of a reduction in the gemeprost dose from the standard 1 mg to 0.5 mg. To reduce the rate of incomplete abortion associated with this procedure, it is recommended that misoprostol not be used in women with 49 or more days of amenorrhea.
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