100
Participants
Start Date
April 9, 2017
Primary Completion Date
January 5, 2018
Study Completion Date
July 24, 2020
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.
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.
The University of Oklahoma Health Sciences Center, Oklahoma City
Collaborators (1)
Ferring Pharmaceuticals
INDUSTRY
University of Oklahoma
OTHER