Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Singleton pregnancy

• Gestational age ≥ 38 weeks

• Fetal cephalic presentation

• Bishop score < 6

Exclusion Criteria:

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

• No more than 3 previous vaginal births

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

• Premature rupture of the membranes

• Oligohydramnios