A multicentre randomized comparative clinical trial of 200 mg RU486 (mifepristone) single dose followed by either 5 mg 9-methylene PGE(2) gel (meteneprost) or 600 mu g oral PGE(1) (misoprostol) for termination of early pregnancy within 28 days of missed menstrual period

A multicentre, randomized, comparative clinical trial of 200 mg RU486 (Mife pristone) followed 48 h later by either 5 mg 9-methylene PGE(2) vaginal gel (meteneprost) or 600 mug oral PGE(1) (misoprostol) for termination of preg nancy within 28 days of the missed period, was carried out through the Indi an Council of Medical Research's (ICMR) network of Human Reproduction Resea rch Centres (HRRCs). A total of 893 subjects were assessed regarding their therapeutic responses to the two different treatment groups. The results in dicated a success rate of 84.6% among 453 women treated with RU486 followed by 9 methylene PGE(2) vaginal gel, that was not significantly different fr om the success rate of 87.7% observed in 440 women treated with RU486 follo wed by oral PGE(1). The majority of study subjects (90%) started bleeding w ithin 72 h. About 26% of the subjects had started bleeding before the admin istration of any prostaglandin. The average duration of bleeding in all the subjects was about 7 days. No life threatening side effects were observed among the subjects in two treatment groups. Gastro-intestinal complaints we re reported more often by women treated with oral PGE(1) as compared to tho se treated with 9-methylene vaginal PGE(2) gel; nausea occurred in 25.7% an d 19.2%, vomiting in 6.8% and 4.6%, and diarrhoea in 4.8% and 0.9% of the s ubjects in the 2 treatment groups, respectively. Fever higher than 38 degre esC and severe abdominal pain were reported by 4.2% and 5.0% of all subject s treated, respectively. Intravenous infusion of glucose and saline was req uired by 6 subjects in each treatment of the prostaglandin treated groups. Blood transfusion was required in 2 subjects, one in each treatment group, for profuse bleeding. (C) 2000 Elsevier Science Inc. All rights reserved.