Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Dinoprostone; Misoprostol

Criteria

Inclusion Criteria:

• Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

Exclusion Criteria:

• No uterine scar (no previous delivery by cesarean section)

• No multiple gestation

• No condition that disallows use of prostaglandins for induction of labor

• No more than 3 previous vaginal births beyond 24 weeks gestation