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

NACompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

September 12, 2017

Primary Completion Date

December 1, 2022

Study Completion Date

December 1, 2022

Conditions
Labor Induction
Interventions
PROCEDURE

Amniotomy

Artificially rupturing membranes

DEVICE

Foley Catheter

Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.

DRUG

Misoprostol

Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.

Trial Locations (1)

60611

Prentice Women's Hospital, Chicago

All Listed Sponsors
lead

Northwestern University

OTHER

NCT03039036 - Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction | Biotech Hunter | Biotech Hunter