Conditions: Cervical Ripening Induction of Labor
Keywords: Pharmacokinetics Misoprostol Vaginal Insert Induction of labor Cervical Ripening Rate of Cesarean section
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.

Detailed description:

Arms:
arm 1: MVI 200 mcg vaginal insert

Interventions: intervention 1: MVI 200
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.

Protocol document: