A randomised study of two doses of gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy

Abstract

Two regimens of the prostaglandin E1 analogue, gemeprost, in combination with mifepristone were compared in a randomised trial for termination of pregnancy between 12-19 weeks. Thirty-six hours after treatment with 200 mg mifepristone, women were allocated at random to receive either 4 x 1 mg (Group I) or 4 x 0.5 mg (Group II) gemeprost by vaginal pessary every 6 hours (n = 50 in each group). If abortion had not occurred after 24 h, 5 x 1 mg of gemeprost was administered every 3 h to both groups of women. Although the median abortion interval was slightly shorter in the 1 mg group (7.8 h vs. 8.4 h, p = 0.5), the cumulative abortion rates at 24 h were similar (98% vs. 96%). Women in Group I required significantly more gemeprost to induce abortion than Group II (p < 0.0001). Parous women in both groups required significantly less of the prostaglandin to induce abortion. In Group II, the median abortion interval was significantly longer in primigravidae than multigravidae (9.5 h vs. 6.1 h; p < 0.02). There were no significant differences between the groups in the incidence of vomiting, diarrhoea or the request for analgesia. The results suggest that in parous women, the dose of gemeprost can be reduced to 0.5 mg every 6 h within the first 24 h without loss of clinical efficacy.

PIP: Two regimens of prostaglandin E1 analogue, gemeprost, in combination with mifepristone were compared in a randomized trial for termination of pregnancy at 12-19 weeks. 100 women requesting second trimester abortion were recruited at the Gynecological Department of the Edinburgh Royal Infirmary, Scotland. The women were given a single oral dose of 200 mg mifepristone in the medical abortion unit and allowed home. 36 hours after treatment with 200 mg mifepristone, women were allocated at random to receive either 4 x 1 mg (Group I) or 4 x 0.5 mg (Group II) gemeprost by vaginal pessary every 6 hours (n = 50 m each group). If abortion had not occurred after 24 hours, 5 x 1 mg of gemeprost was administered every 3 hours in both groups of women. Although the median abortion interval was slightly shorter in the 1 mg group (7.8 vs. 8.4 hours, p = 0.5), the cumulative abortion rates at 24 hours were similar (98% vs. 96%). Women in Group I required significantly more gemeprost to induce abortion than those in Group II (p 0.0001). Parous women in both groups required significantly less of the prostaglandin to induce abortion. Primigravidae took longer to abort than multigravidae, although the difference only reached statistical significance in Group II (median 9.5 hours vs. 6.1 hours; p 0.02). The women in Group II required a lower dose of gemeprost to complete the abortion than those in Group I (median 1 mg vs. 2 mg; p 0.0001). There were no significant differences between the groups in the incidence of vomiting, diarrhea or the request for analgesia. Surgical evacuation of the uterus because of retained or incomplete placenta was required in approximately 1/5 of women in each group. One woman in Group II required blood transfusion because of a retained placenta after expulsion of the fetus. The results suggest that in parous women the dose of gemeprost can be reduced to 0.5 mg every 6 hours within the first 24 hours without loss of clinical efficacy.