Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb

NACompletedINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Pre-induction Dilation of Cervix
Interventions
DEVICE

Dilapan

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.

DEVICE

Foley Catheter

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.

Trial Locations (2)

77555

University of Texas, Galveston

UTMB Galveston, Galveston

Sponsors
All Listed Sponsors
collaborator

Medicem International CR s.r.o.

INDUSTRY

lead

The University of Texas Medical Branch, Galveston

OTHER