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

Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Device: Outpatient Foley catheter

• Study Type: Interventional
• Enrollment (Estimated): 2300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Levine, MD, MSCE; Phone Number: 215-283-7373; Email: lisa.levine@pennmedicine.upenn.edu
• Study Contact Backup: Name: Meaghan McCabe, MPH; Phone Number: 215-283-7373; Email: meaghan.mccabe@pennmedicine.upenn.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Recruiting
      • Christiana Care Health Services, Inc.
      • Contact: Amy Staples; Email: amy.staples@christianacare.org
      • Contact: Carrie Kitto; Email: ckitto@christianacare.org
      • Principal Investigator: Anthony Sciscione, MD
      • Sub-Investigator: Suneet Chauhaun, MD
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Recruiting
      • Princeton Medical Center
      • Principal Investigator: Lisa D Levine, MD, MSCE
      • Contact: Naeemah Turner; Email: naeemah.turner@pennmedicine.upenn.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Meaghan McCabe, MPH; Email: meaghan.mccabe@pennmedicine.upenn.edu
      • Principal Investigator: Lisa D Levine, MD, MSCE
      • Contact: Naeemah Turner; Email: naeemah.turner@pennmedicine.upenn.edu
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • University of Texas at Austin
      • Principal Investigator: Alison G Cahill, MD, MSCI
      • Contact: Brooke lasher; Email: brooke.lasher@austin.utexas.edu
  • Utah
    • Provo, Utah, United States, 84604
      • Recruiting
      • Intermountain Health Utah Valley Hospital
      • Contact: Stacey Breeze; Phone Number: 801-507-7433; Email: stacey.breeze@imail.org
      • Principal Investigator: Jessica Page, MD
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Principal Investigator: Robert M Silver, MD
      • Contact: Stephen Forsyth; Email: stephen.forsyth@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient cervical ripening with Foley; Cervical ripening will begin with a Foley balloon in the outpatient setting	Device: Outpatient Foley catheter; Outpatient Foley catheter placement for induction of labor
No Intervention: Standard of care Inpatient cervical ripening; Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Cesarean Delivery	Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal morbidity incidence	Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolis and hospital readmission with 6 weeks	Within 6 weeks of delivery
Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)	Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction	From time of delivery to discharge from hospital, up to 6 weeks from delivery
Neonatal morbidity incidence	Defined as a composite endpoint consisting of at least one incidence of the following outcomes: acidemia, respiratory failure/insufficiency, hypoxic-ischemic encephalopathy, treatment for hypoglycemia or suspected sepsis	Within 6 weeks of delivery
Maternal patient perception of control	Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control	From time of delivery to discharge from hospital, up to 6 weeks from delivery
Maternal overall length of stay	Measured by hours from admission to postpartum discharge	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Maternal postpartum length of stay	Measured by hours from delivery to postpartum discharge	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Neonatal length of stay	Length of stay from birth to discharge, measured in hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
NICU admission	Admission to neonatal intensive care unit	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
NICU stay greater than 48 hours	Admission to the NICU for more than 48 hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Perceived stress scale-10 questions	A validated 10 question scale evaluating perceived stress	From time of delivery to discharge from hospital, up to 6 weeks from delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heterogeneity of Treatment Effect/prespecified sub-groups	Pre-specified subgroups to be included are: Starting cervical dilation (<1cm vs. >=1cm), Bishop score (<6 vs. >=6), BMI (<30 kg/m2 vs. >=30 kg/m2), Race/ethnicity (Black, White, Asian, Other; Hispanic/Non-Hispanic), Gestational age at start of induction (37-39w6d vs. >=40 weeks), Advanced Maternal Age (AMA) (>=35 yo) vs not AMA (<35 yo)	within 6 weeks of delivery

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Lisa Levine, MD, MSCE, University of Pennsylvaina; Principal Investigator: Alison Cahill, MD, MSCI, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Outpatient cervical ripening; Foley balloon catheter
• Other Study ID Numbers: 851906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No