Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Pennsylvania
About this trial
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
Qualifiers
Eligible for induction of labor
Live singleton gestation ≥37 weeks and <42 weeks
Nulliparous, ≥18 years of age with no previous deliveries >20 weeks
Cephalic presentation
Disqualifiers
Known oligohydramnios (DVP <2cm)
Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)
Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10
Vaginal bleeding or concern for/known abruption prior to Foley placement
Trial design
Treatments tested in this trial
- Outpatient Foley catheter
Treatment groups
2,300 Participants
are divided into 2 treatment groupsLocations
6Christiana Care Health Services, Inc.19718, NewarkDelaware, United States
Princeton Medical Center08536, PlainsboroNew Jersey, United States
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
University of Texas at Austin78712, AustinTexas, United States
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Source ClinicalTrials.gov