338
Participants
Start Date
November 7, 2018
Primary Completion Date
November 5, 2021
Study Completion Date
November 5, 2021
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.
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."
Columbia University Irving Medical Center, New York
UTMB Galveston, Galveston
Collaborators (1)
Medicem International CR s.r.o.
INDUSTRY
The University of Texas Medical Branch, Galveston
OTHER