Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
NCT05759988
This study is recruiting at 6 US sites in 5 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Induction of Labor Affected Fetus / Newborn
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 to 60 years
- Sex
- Female
- Healthy volunteers
- Accepted
- Sponsor
- University of Pennsylvania
- Last updated on ClinicalTrials.gov
- February 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Delaware · 1
- Christiana Care Health Services, Inc. · Newark, DE
New Jersey · 1
- Princeton Medical Center · Plainsboro, NJ
Pennsylvania · 1
- University of Pennsylvania · Philadelphia, PA
Texas · 1
- University of Texas at Austin · Austin, TX
Utah · 2
- Intermountain Health Utah Valley Hospital · Provo, UT
- University of Utah · Salt Lake City, UT
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.