At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term
In Brief
A Phase 3 clinical trial evaluating MVI 200 and Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery and 2 related conditions. Completed, enrolled 1,358 participants across 34 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.