Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

NACompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

November 5, 2021

Study Completion Date

November 5, 2021

Conditions
Labor, InducedCervix Uteri-Diseases
Interventions
DEVICE

Outpatient Dilapan-S

After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L\&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L\&D unit for standard protocol of labor induction.

DEVICE

Inpatient Dilapan-S

"After Dilapan-S placement, subjects will be admitted to L\&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain nothing per os (NPO), nothing per vagina and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated."

Trial Locations (2)

10032

Columbia University Irving Medical Center, New York

77555

UTMB Galveston, Galveston

Sponsors
All Listed Sponsors
collaborator

Medicem International CR s.r.o.

INDUSTRY

lead

The University of Texas Medical Branch, Galveston

OTHER