Recruiting

Foley Catheter

Sponsor:

University of Pennsylvania

Code:

NCT05759988

Conditions

Induction of Labor Affected Fetus / Newborn

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Outpatient Foley catheter

Study Details

Brief summary:

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

Induction of Labor Affected Fetus / Newborn

Study ID

NCT05759988

Start date

Apr 13, 2023

Status verified date

Jan, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Outpatient Foley catheter

Outpatient Foley catheter placement for induction of labor

Primary outcome measure

  • Incidence of Cesarean Delivery [ Time Frame: At delivery ]

Central Contacts and Locations

Central contacts

Lisa Levine, MD, MSCE

215-283-7373lisa.levine@pennmedicine.upenn.edu

Meaghan McCabe, MPH

215-283-7373meaghan.mccabe@pennmedicine.upenn.edu

Locations

Christiana Care Health Services, Inc.

Recruiting

Newark, Delaware, United States, 19718

Contacts

Carrie Kitto

ckitto@christianacare.org

Amy Staples

amy.staples@christianacare.org

Principal Investigator:

Anthony Sciscione, MD

Princeton Medical Center

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Naeemah Turner

naeemah.turner@pennmedicine.upenn.edu

Principal Investigator:

Lisa D Levine, MD, MSCE

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Naeemah Turner

naeemah.turner@pennmedicine.upenn.edu

Meaghan McCabe, MPH

meaghan.mccabe@pennmedicine.upenn.edu

Principal Investigator:

Lisa D Levine, MD, MSCE

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Brooke lasher

brooke.lasher@austin.utexas.edu

Principal Investigator:

Alison G Cahill, MD, MSCI

Intermountain Health Utah Valley Hospital

Recruiting

Provo, Utah, United States, 84604

Contacts

Stacey Breeze

801-507-7433stacey.breeze@imail.org

Principal Investigator:

Jessica Page, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Stephen Forsyth

stephen.forsyth@hsc.utah.edu

Principal Investigator:

Robert M Silver, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Foley balloon catheter
  • Outpatient cervical ripening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-02.