Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 9, 2017

Primary Completion Date

January 5, 2018

Study Completion Date

July 24, 2020

Conditions
Cervical RipeningInduction of Labor
Interventions
DRUG

Cervidil 10 MG Vaginal Insert

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

DEVICE

Foley Catheter

The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.

Trial Locations (1)

73104

The University of Oklahoma Health Sciences Center, Oklahoma City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ferring Pharmaceuticals

INDUSTRY

lead

University of Oklahoma

OTHER