Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Recruiting now · Not applicable
Conditions studied: Induction of Labor Affected Fetus / Newborn
In brief
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.
Key facts
- Study ID
- NCT05759988
- Run by
- University of Pennsylvania
- People needed
- 2300
- Starts
- 2023-04-13
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
- Intact membranes
- Bishop score ≤8 and cervical dilation <3 cm
- English or Spanish speaking (Able to read/understand consent and instructions)
- Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter
You may not qualify if…
- 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
- Chorioamnionitis
- Any fetal growth restriction
- Preeclampsia with severe features
- Severe chronic hypertension
- Type 1 diabetes or poorly controlled pre-gestational diabetes
- Sickle cell disease
- Major fetal anomaly
- Women on therapeutic anticoagulation
- Decreased fetal movement
- HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria)
- Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course
Where it is running
- Christiana Care Health Services, Inc. — Newark, Delaware, United States (enrolling)
- Princeton Medical Center — Plainsboro, New Jersey, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- University of Texas at Austin — Austin, Texas, United States (enrolling)
- Intermountain Health Utah Valley Hospital — Provo, Utah, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.