Comparison of Misoprostol Ripening Efficacy With Dilapan

PHASE4CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

November 15, 2018

Primary Completion Date

July 21, 2021

Study Completion Date

July 21, 2021

Conditions
Labor Onset and Length AbnormalitiesInduced; Birth
Interventions
DEVICE

Dilapan

Dilapan-S® is a mechanical method for cervical ripening using rods made of a patented hydrogel Aquacryl, it is marketed in form of rods of 3 and 4 mm diameter. It is FDA approved for cervical ripening.

DRUG

Misoprostol

"25mcg of Misoprostol will be administered orally every 2 hours (maximum of 6 doses)~Misoprostol is a prostaglandin E1 analog approved for treatment and prevention of gastric ulcers. The use of Misoprostol appears to be safe and effective for induction of labor when used in low dose."

Trial Locations (2)

10034

New York Presbyterian - Allen Hospital, New York

77555

University of Texas, Galveston

Sponsors
All Listed Sponsors
collaborator

Medicem International CR s.r.o.

INDUSTRY

lead

Columbia University

OTHER