Conditions: Reducing Time to Vaginal Delivery Cervical Ripening Induction of Labor
Keywords: Misoprostol vaginal insert Dinoprostone vaginal insert Cervidil Cervical ripening Induction of labor Rate of cesarean section
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1358
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.

Detailed description:

Arms:
arm 1: MVI 200 mcg vaginal insert arm 2: 10 mg Dinoprostone vaginal insert

Interventions: intervention 1: MVI 200 intervention 2: Dinoprostone Vaginal Insert (DVI)
Intervention descriptions: intervention 1: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. intervention 2: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.

Protocol document: