Actively Recruiting
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Led by University of Pennsylvania · Updated on 2026-02-02
2300
Participants Needed
6
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for induction of labor
- Live singleton pregnancy between 37 weeks and less than 42 weeks
- First pregnancy (nulliparous), age 18 or older with no previous deliveries over 20 weeks
- Baby is in head-down position (cephalic presentation)
- Amniotic membranes intact
- Bishop score 8 or less and cervical dilation less than 3 cm
- Able to read and understand English or Spanish consent and instructions
- Have reliable transportation and a safe home to return to with the Foley catheter
You will not qualify if you...
- Known low amniotic fluid (oligohydramnios) with deepest vertical pocket less than 2 cm
- Known excessive amniotic fluid (polyhydramnios) with amniotic fluid index 30 or more at delivery
- Concerns about fetal health during antenatal testing (e.g., fetal decelerations, low biophysical profile)
- Vaginal bleeding or suspicion/known placental abruption before Foley placement
- Infection of the membranes (chorioamnionitis)
- Any fetal growth restriction
- Severe preeclampsia
- Severe chronic high blood pressure
- Type 1 diabetes or poorly controlled pre-gestational diabetes
- Sickle cell disease
- Major fetal anomaly
- Use of therapeutic blood thinners
- Decreased fetal movements
- HIV positive status
- Maternal heart disease requiring continuous heart monitoring during induction and labor
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Trial Site Locations
Total: 6 locations
1
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Actively Recruiting
2
Princeton Medical Center
Plainsboro, New Jersey, United States, 08536
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
University of Texas at Austin
Austin, Texas, United States, 78712
Actively Recruiting
5
Intermountain Health Utah Valley Hospital
Provo, Utah, United States, 84604
Actively Recruiting
6
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
L
Lisa Levine, MD, MSCE
CONTACT
M
Meaghan McCabe, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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