Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
NCT ID: NCT05759988
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2300 participants
INTERVENTIONAL
2023-04-13
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Outpatient cervical ripening with Foley
Cervical ripening will begin with a Foley balloon in the outpatient setting
Outpatient Foley catheter
Outpatient Foley catheter placement for induction of labor
Standard of care Inpatient cervical ripening
Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent
No interventions assigned to this group
Interventions
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Outpatient Foley catheter
Outpatient Foley catheter placement for induction of labor
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course
18 Years
60 Years
FEMALE
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Lisa Levine
Associate Professor, Division of Maternal Fetal Medicine
Principal Investigators
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Lisa Levine, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvaina
Alison Cahill, MD, MSCI
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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Christiana Care Health Services, Inc.
Newark, Delaware, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas at Austin
Austin, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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851906
Identifier Type: -
Identifier Source: org_study_id
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