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.
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.
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
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Christiana Care Health Services, Inc., Newark, Delaware, United States, 19718
University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104
University of Texas at Austin, Austin, Texas, United States, 78712
University of Utah, Salt Lake City, Utah, United States, 84112
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to 60 Years
FEMALE
Yes
University of Pennsylvania,
Lisa Levine, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvaina
Alison Cahill, MD, MSCI, PRINCIPAL_INVESTIGATOR, University of Texas at Austin
2027-06-30