D A Wing1, M J Fassett, D R Mishell. 1. Department of Obstetrics-Gynecology, Division of Maternal-Fetal Medicine, Women's & Children's Hospital, Keck School of Medicine of the University of Southern California, Los Angeles, California 90033, dwing@hsc.usc.edu
Abstract
OBJECTIVE: To compare the effect of mifepristone with placebo on cervical ripening before labor induction in prolonged pregnancies. METHODS:One hundred eighty women with pregnancies beyond 41 weeks and undilated, uneffaced cervices were assigned randomly to receive mifepristone 200 mg or placebo and observed for 24 hours. We then gave intravaginal misoprostol 25 microg every 4 hours or intravenous oxytocin. We expected 60% of placebo-treated and 80% of mifepristone-treated women to deliver vaginally within 48 hours. RESULTS: Among 180 subjects, 97 receivedmifepristone and 83 received placebo. The mean interval (+/- standard deviation [SD]) from start of induction to delivery was 2209 +/- 698 minutes for mifepristone-treated subjects and 2671 +/- 884 minutes for placebo-treated subjects (P <.001, log-transformed data). Twelve (13. 6%) mifepristone-treated women and seven (10.8%) placebo-treated women delivered vaginally on day 1 (P =.60). After 24 hours, the median Bishop score for both groups was 3 (0-11) (P =.51). One hundred thirty-one subjects required misoprostol, 65 (67.0%) were mifepristone-treated women, and 66 (79.5%) placebo-treated women (P =.06). The median (range) oxytocin dose was 871.5 (0-22,174) mU for mifepristone-treated women and 2021.0 (0-24,750) mU for placebo-treated women (P =.02). Seventy-seven (87.5%) mifepristone-treated women and 46 (70.8%) placebo-treated women delivered vaginally 48 hours after the start of treatment (P =.01). There were nine cesareans in the mifepristone group and 18 in the placebo group (P =.02). More nonreassuring fetal heart rate patterns and uterine contractile abnormalities occurred in mifepristone-treated subjects. There were no statistically significant differences in neonatal outcomes between groups. CONCLUSION:Mifepristone had a modest effect on cervical ripening when given 24 hours before labor induction, appearing to reduce the need for misoprostol and oxytocin compared with placebo.
RCT Entities:
OBJECTIVE: To compare the effect of mifepristone with placebo on cervical ripening before labor induction in prolonged pregnancies. METHODS: One hundred eighty women with pregnancies beyond 41 weeks and undilated, uneffaced cervices were assigned randomly to receive mifepristone 200 mg or placebo and observed for 24 hours. We then gave intravaginal misoprostol 25 microg every 4 hours or intravenous oxytocin. We expected 60% of placebo-treated and 80% of mifepristone-treated women to deliver vaginally within 48 hours. RESULTS: Among 180 subjects, 97 received mifepristone and 83 received placebo. The mean interval (+/- standard deviation [SD]) from start of induction to delivery was 2209 +/- 698 minutes for mifepristone-treated subjects and 2671 +/- 884 minutes for placebo-treated subjects (P <.001, log-transformed data). Twelve (13. 6%) mifepristone-treated women and seven (10.8%) placebo-treated women delivered vaginally on day 1 (P =.60). After 24 hours, the median Bishop score for both groups was 3 (0-11) (P =.51). One hundred thirty-one subjects required misoprostol, 65 (67.0%) were mifepristone-treated women, and 66 (79.5%) placebo-treated women (P =.06). The median (range) oxytocin dose was 871.5 (0-22,174) mU for mifepristone-treated women and 2021.0 (0-24,750) mU for placebo-treated women (P =.02). Seventy-seven (87.5%) mifepristone-treated women and 46 (70.8%) placebo-treated women delivered vaginally 48 hours after the start of treatment (P =.01). There were nine cesareans in the mifepristone group and 18 in the placebo group (P =.02). More nonreassuring fetal heart rate patterns and uterine contractile abnormalities occurred in mifepristone-treated subjects. There were no statistically significant differences in neonatal outcomes between groups. CONCLUSION:Mifepristone had a modest effect on cervical ripening when given 24 hours before labor induction, appearing to reduce the need for misoprostol and oxytocin compared with placebo.
Authors: Michael A Kirby; Anne C Heuerman; Melisa Custer; Abigail E Dobyns; Ryan Strilaeff; Kathleen N Stutz; Jaclyn Cooperrider; Joseph G Elsissy; Steven M Yellon Journal: Reprod Sci Date: 2016-05-27 Impact factor: 3.060
Authors: Steven M Yellon; Abigail E Dobyns; Hailey L Beck; James T Kurtzman; Robert E Garfield; Michael A Kirby Journal: PLoS One Date: 2013-12-10 Impact factor: 3.240