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Study identifier: NCT05759988 Synced from ClinicalTrials.gov · July 30, 2026
● Recruiting

Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)

Condition: Induction of Labor Affected Fetus / Newborn  ·  Sponsor: University of Pennsylvania

PhaseNA
Planned participants2300
Who can joinFemale, 18 Years to 60 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Lisa Levine, MD, MSCE  ·  215-283-7373  ·  lisa.levine@pennmedicine.upenn.edu

Meaghan McCabe, MPH  ·  215-283-7373  ·  meaghan.mccabe@pennmedicine.upenn.edu

Always discuss trial participation with your own doctor first.

Locations (6)

Christiana Care Health Services, Inc.Newark, Delaware, United StatesRecruiting
Princeton Medical CenterPlainsboro, New Jersey, United StatesRecruiting
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesRecruiting
University of Texas at AustinAustin, Texas, United StatesRecruiting
Intermountain Health Utah Valley HospitalProvo, Utah, United StatesRecruiting
University of UtahSalt Lake City, Utah, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05759988