Inducing embryo expulsion in women with spontaneous fetal death in the first trimester. Use of mifepristone (RU-486) in a prospective,randomized, double blind study

At Antoine Beclere Hospital in Clamart, France, over a six month period, health workers randomly allocated 46 women diagnosed with non-advancing pregnancy during the first trimester with the embryo still in utero to either the group receiving three tablets of 600 mg mifepristone (RU-486) or to the group receiving three tablets of a placebo. They observed women from both groups for five days. The aim of this prospective double-blind study was to determine whether RU-486 without a prostaglandin could expedite expulsion of the embryo of the spontaneous abortions during the first trimester. Embryo expulsion was much more common in the RU-486 group than the placebo group (82% vs. 8%; p 0.01). 19 placebo patients had to undergo vacuum aspiration (local anesthesia in 9 cases and general anesthesia in 10 cases). Six RU-486 patients also had to undergo aspiration (4 for failure of RU-486 and 2 for hemorrhaging 1-2 days after treatment). In the two hemorrhaging RU-486 cases, the physicians found the embryo in the cervical os as it was in the process of expulsion so they did not consider these cases as failures. The decline in progesterone was greatest in the RU-486 group (8.9 vs. 1.7 pg/ml; p 0.05) as was also the case with human chorionic gonadotropin (hCG). All the women in the RU-486 group experienced bleeding compared to 24% in the control group (p 0.01). Even though the RU-486 group was more likely to experience pain (52% vs. 24%), the difference was not significant (p = 0.08). Factors influencing spontaneous expulsion in the control group were amenorrhea greater than 70 days and a low initial level of progesterone and hCG. Among the RU-486 group, they were amenorrhea less than 71 days and a high initial level of progesterone and hCG.