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Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Sponsor: University of Pennsylvania
Summary
A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.
Official title: Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
2300
Start Date
2023-04-13
Completion Date
2027-06-30
Last Updated
2026-02-02
Healthy Volunteers
Yes
Interventions
Outpatient Foley catheter
Outpatient Foley catheter placement for induction of labor
Locations (6)
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Princeton Medical Center
Plainsboro, New Jersey, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas at Austin
Austin, Texas, United States
Intermountain Health Utah Valley Hospital
Provo, Utah, United States
University of Utah
Salt Lake City, Utah, United States