Conditions: Cervical Ripening Induction of Labor
Keywords: Misoprostol vaginal insert Induction of labor Cervical ripening Rate of cesarean section
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 374
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.

Detailed description:

Arms:
arm 1: MVI 100 mcg vaginal insert arm 2: MVI 150 mcg vaginal insert arm 3: MVI 200 mcg vaginal insert

Interventions: intervention 1: MVI 100 intervention 2: MVI 150 intervention 3: MVI 200
Intervention descriptions: intervention 1: Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 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 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 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 3: 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.

Protocol document: