FOLCROM Trial: Foley Catheter in Rupture of Membranes

NACompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

August 31, 2016

Conditions
Premature Rupture of Membranes
Interventions
DEVICE

Foley Catheter

The balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.

DRUG

Oxytocin

Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.

Trial Locations (5)

17822

Geisinger Medical Center, Danville

18103

Lehigh Valley Hospital, Allentown

18711

Geisinger Wyoming Valley, Wilkes-Barre

19718

Christiana Care Health System CCHS, Newark

85006

Banner Good Samaritan Regional Medical Center, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Geisinger Clinic

OTHER

NCT01973036 - FOLCROM Trial: Foley Catheter in Rupture of Membranes | Biotech Hunter | Biotech Hunter