Ripening Interventions: Prostaglandins vs EASI Catheter

• Status: Terminated
• Trial end date: 2008-06-18
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

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

Details

• Lead Sponsor: Loyola University
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Singleton pregnancy

• Cephalic presentation

• 36 completed weeks of gestation

• Intact membranes

• Unfavorable cervix (defined as Bishop score < 5)

• Indication for induction of labor

• Fetal Station less than or equal to -3

Exclusion Criteria:

• Clinically significant vaginal bleeding

• Evidence of spontaneous labor (3 contractions in 10 minutes)

• Contraindication to induction of labor or to use of prostaglandins

• Fetal station higher than -3