W Eric Frohn1, Stephanie Simmons, S J Carlan. 1. Department of Obstetrics and Gynecology, Arnold Palmer Hospital for Children and Women, Division of Orlando Regional Healthcare, Orlando, Florida 32806, USA.
Abstract
OBJECTIVE: To compare intravaginal misoprostol to prostaglandin (PG) E2 for cervical ripening in women with premature rupture of the membranes (PROM) after 34 weeks of gestation. METHODS:Women with PROM after 34 weeks of gestation and an unripe cervix were randomized to receive PGE2 (2.5 mg) or misoprostol (50 microg). Both agents were placed intravaginally immediately after randomization, and the dose was repeated 6 hours later if necessary. After another 6 hours from the second insertion, oxytocin treatment was started if labor had not begun. Forty patients in each group were required to show a 30% improvement in delivery within 12 hours in the misoprostol group. RESULTS:One hundred nine patients were randomized; 54 were assigned tomisoprostol and 55 to PGE2. Important demographic and clinical characteristics were similar between the groups. The mean time from first insertion to delivery was 16.4 hours in the misoprostol group and 22.0 hours in the PGE2 group. A second dose was required less frequently in the misoprostol group (22% vs 62% in the PGE2 group), and the percentage of patients delivered within 12 hours was higher in the misoprostol group (41% vs 16%). Tachysystole occurred in 20% and 6% of women in the misoprostol and PGE2 groups, respectively. Hyperstimulation occurred in 9% and 0%, and cesarean delivery in 19% and 26% of women in the misoprostol and PGE2 groups, respectively. Neonatal outcome was similar between groups. CONCLUSION:Intravaginal misoprostol is more effective than local PGE2 application to treat PROM after 34 weeks of gestation, but tachysystole occurs more commonly with misoprostol.
RCT Entities:
OBJECTIVE: To compare intravaginal misoprostol to prostaglandin (PG) E2 for cervical ripening in women with premature rupture of the membranes (PROM) after 34 weeks of gestation. METHODS:Women with PROM after 34 weeks of gestation and an unripe cervix were randomized to receive PGE2 (2.5 mg) or misoprostol (50 microg). Both agents were placed intravaginally immediately after randomization, and the dose was repeated 6 hours later if necessary. After another 6 hours from the second insertion, oxytocin treatment was started if labor had not begun. Forty patients in each group were required to show a 30% improvement in delivery within 12 hours in the misoprostol group. RESULTS: One hundred nine patients were randomized; 54 were assigned to misoprostol and 55 to PGE2. Important demographic and clinical characteristics were similar between the groups. The mean time from first insertion to delivery was 16.4 hours in the misoprostol group and 22.0 hours in the PGE2 group. A second dose was required less frequently in the misoprostol group (22% vs 62% in the PGE2 group), and the percentage of patients delivered within 12 hours was higher in the misoprostol group (41% vs 16%). Tachysystole occurred in 20% and 6% of women in the misoprostol and PGE2 groups, respectively. Hyperstimulation occurred in 9% and 0%, and cesarean delivery in 19% and 26% of women in the misoprostol and PGE2 groups, respectively. Neonatal outcome was similar between groups. CONCLUSION: Intravaginal misoprostol is more effective than local PGE2 application to treat PROM after 34 weeks of gestation, but tachysystole occurs more commonly with misoprostol.