Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

May 22, 2021

Study Completion Date

October 18, 2021

Conditions
Induction of Labor Affected Fetus / Newborn
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.

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.

Trial Locations (1)

19713

Christiana Care Health Systems, Newark

All Listed Sponsors
lead

Christiana Care Health Services

OTHER

NCT04496908 - Early Versus Delayed Artificial Rupture of Membranes (AROM Trial) | Biotech Hunter | Biotech Hunter