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 groupsSponsors and collaborators
Source ClinicalTrials.gov