Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Start Date
4/13/2023
Completion Date
6/30/2027
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.
Eligibility Criteria
Age Range: 18 years to 60 years
Interventions
Outpatient Foley catheter
Conditions
Locations
Christiana Care Health Services, Inc.
Newark, Delaware 19718
United States
Princeton Medical Center
Plainsboro, New Jersey 08536
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
University of Texas at Austin
Austin, Texas 78712
United States
Intermountain Health Utah Valley Hospital
Provo, Utah 84604
United States
University of Utah
Salt Lake City, Utah 84112
United States