Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)

Part of paid clinical trials in Newark, Delaware.

Sponsor
University of Pennsylvania
Study ID
NCT05759988
Status
Recruiting
Apply to this trial

Conditions

  • Induction of Labor Affected Fetus / Newborn

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Outpatient Foley catheter — DEVICE
    Outpatient Foley catheter placement for induction of labor

Study Details

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 Dates

Start date
Apr 13, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
2,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Outpatient cervical ripening with Foley
    Cervical ripening will begin with a Foley balloon in the outpatient setting
  • No Intervention: Standard of care Inpatient cervical ripening
    Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent

Primary Outcome Measure

Incidence of Cesarean Delivery [ Time Frame: At delivery ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Christiana Care Health Services, Inc.NewarkDelaware19718
Carrie Kitto
[email protected]
Amy Staples
[email protected]
Anthony Sciscione, MD (PRINCIPAL_INVESTIGATOR)
Suneet Chauhaun, MD (SUB_INVESTIGATOR)
Princeton Medical CenterPlainsboroNew Jersey08536
Naeemah Turner
[email protected]
Lisa D Levine, MD, MSCE (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Naeemah Turner
[email protected]
Meaghan McCabe, MPH
[email protected]
Lisa D Levine, MD, MSCE (PRINCIPAL_INVESTIGATOR)
University of Texas at AustinAustinTexas78712
Brooke lasher
[email protected]
Alison G Cahill, MD, MSCI (PRINCIPAL_INVESTIGATOR)
Intermountain Health Utah Valley HospitalProvoUtah84604
Stacey Breeze
[email protected]
801-507-7433
Jessica Page, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Stephen Forsyth
[email protected]
Robert M Silver, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newark, DE

By research site
Christiana Care Health Services, Inc.· Newark, DEPrinceton Medical Center· Plainsboro, NJUniversity of Pennsylvania· Philadelphia, PAUniversity of Texas at Austin· Austin, TXIntermountain Health Utah Valley Hospital· Provo, UTUniversity of Utah· Salt Lake City, UT

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