Termination of second trimester pregnancy with sulprostone and mifepristone: A randomized double-blind placebo-controlled trial

Abstract

A prospective randomized double-blind placebo-controlled trial was conducted in 13 subjects to find out whether mifepristone treatment could facilitate termination of second trimester pregnancy by sulprostone. The women received either 600 mg oral mifepristone or placebo tablets 36 hours before the administration of intramuscular sulprostone 0.5 mg every 6 hours. The median interval between the administration of sulprostone and abortion in the mifepristone group (4.6 hours) was significantly shorter than that in the placebo group (20 hours). The amount of sulprostone required was also significantly less in the mifepristone group. There was no significant difference in the incidence of side effects or analgesic requirement between the two groups. We conclude that oral mifepristone is useful in facilitating termination of second trimester pregnancies by sulprostone. | Termination of second trimester pregnancies has been related to side effects. ATtempts have been made to shorten the induction-abortion interval and to lower dosage of the prostaglandins in order to reduce the incidence of side effects. In this study, 13 second trimester patients 18-35 years of age were administered mifepristone before the procedure which called for administration of intramuscular sulprostone; the trial was prospective and randomized and called for double-blind placebo controls. The objective was to determine whether administration of mifepristone would facilitate termination of the pregnancy. 6 women received 600 mg oral mifepristone in an unmarked packet 36 hours before the administration of .5 mg sulprostone intramuscularly every 6 hours until the patient felt strong uterine contractions. 7 women received a placebo in an unmarked packet at the same time as those receiving mifepristone followed by sulprostone. Side effects, uterine contractions, blood pressure, and pulse were recorded every 2 hours. There were no significant differences in mean age of patients or in weight and height. Women were excluded who had any significant past or present medical disorder, who were using prescription drugs regularly, who were nursing or using hormonal contraception during or just before conception, or who were using an intrauterine device. The statistically significant results showed that the induction-abortion interval was shorter and the amount of sulprostone lower in the mifepristone group. 3 patients in the placebo groups did not abort within 24 hours and required administration of oxytocin and further injections of sulprostone. 2 patients (28.6%) in the placebo group required uterine evacuation under general anesthesia, and 4 patients (66.7%) in the placebo group required uterine evacuation due to incomplete abortions, which was not a statistically significant difference. Temperature highs were similar in both groups, but the amount of vomiting or diarrhea and the analgesic requirement was greater in the placebo group, but not significantly so. There was early termination of the study because of unexpected cardiovascular complications in another study; intravenous injection of sulprostone is recommended. The advantages of mifepristone are that it requires no special skills and avoids the complications of the laminaria tent.