Ripening Interventions: Prostaglandins vs EASI Catheter

Stopped early · Phase 4

Conditions studied: Cesarean Section

In brief

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.

Key facts

Study ID

NCT00383942

Run by

Loyola University

People needed

80

Starts

2006-08-31

Expected to finish

2008-06-18

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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