drugset / Trial / NCT03039036

Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

NCT03039036

Completed 69 enrolled Northwestern University
RandomizedParallel-groupOpen-labelTreatment

Summary

Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care. The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.

Timeline

Start
2017-09-12
Primary completion
2022-12-01
Completion
2022-12-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Misoprostol Other / unclassified 25 ug

Indications

No indication recorded.