TERMINATION OF EARLY-PREGNANCY BY 2 REGIMENS OF MIFEPRISTONE WITH MISOPROSTOL AND MIFEPRISTONE WITH PG05 - A MULTICENTER RANDOMIZED CLINICAL-TRIAL IN CHINA

A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with mis oprostol, and mifepristone with PG05 for termination of early pregnanc y (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. in group 1 (n = 301), an initial dose of mifepristone 50 mg was given, fo llowed by 25 mg every 12 hours up to a total doss of 150 mg mifepristo ne, plus a single oral dose of misoprostol 600 mu g in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF(2 alpha) (PG05) 1 mg vaginal supposito ry was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 mu g was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% fo r group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incom plete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were tr eatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined, There were no significant d ifferences among the 3 groups. Lower abdominal pain was the main compl aint which was reported by 82% of the subjects after PGs administratio n. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P<0.001), a nd so was vomiting. It was concluded that misoprostol, as an orally ef fective prostaglandin, in combination with mifepristone for induced ab ortion of early pregnancy was as effective as PG05 vaginal suppository . Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.