Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial.

Abstract

To compare the 50-microgram (misoprostol vaginal insert 50) and 100-microgram (misoprostol vaginal insert 100) dose reservoirs of the misoprostol vaginal insert to 10-mg dinoprostone vaginal insert for time to vaginal delivery and rate of cesarean delivery. A total of 1,308 women requiring cervical ripening (modified Bishop score less than or equal to 4) before induction of labor were randomly assigned to receive misoprostol vaginal insert 100 (n=428), misoprostol vaginal insert 50 (n=443) or 10-mg dinoprostone vaginal insert (n=436). The primary outcomes were time to vaginal delivery and rate of cesarean births. Safety was also assessed by comparing frequency of adverse events. Median time to vaginal delivery was 1,596, 2,127, and 1,650 minutes for misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal insert, respectively (P=.97 and 0.01 compared with dinoprostone vaginal insert, respectively). Of those who delivered in first admission, cesarean deliveries occurred in 119 of 421 (28.3%), 124 of 429 (28.9%), and 115 of 424 (27.1%) of participants treated with misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively (relative risk 1.04, 95% confidence interval 0.84-1.30 for misoprostol vaginal insert 100 and relative risk 1.06, 95% confidence interval 0.86-1.32 for misoprostol vaginal insert 50 compared with dinoprostone vaginal insert). Medication-related adverse events included hyperstimulation syndrome in 17 of 428 (4.0%), 6 of 443 (1.4%), and 21 of 436 (4.8%); and nonreassuring fetal heart rate patterns in 63 of 428 (14.7%), 54 of 443 (12.2%), and 67 of 436 (15.4%) of participants treated with the misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively. The misoprostol vaginal insert 100 and the dinoprostone vaginal insert had similar median time intervals to vaginal delivery, whereas the misoprostol vaginal insert 50 had a significantly longer time to vaginal delivery. The three products had similar cesarean rates and safety profiles.