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

NCT05759988 | Recruiting DMC FDA Device

• 1 other identifier: 851906
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 6

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

Keywords

Foley balloon catheter; Outpatient cervical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Maternal morbidity incidence

  Within 6 weeks of delivery

• Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)

  From time of delivery to discharge from hospital, up to 6 weeks from delivery

• Neonatal morbidity incidence

  Within 6 weeks of delivery

• Maternal patient perception of control

  From time of delivery to discharge from hospital, up to 6 weeks from delivery

• Maternal overall length of stay

  From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

Other Outcomes (1)

• Heterogeneity of Treatment Effect/prespecified sub-groups

  within 6 weeks of delivery

Study Arms (2)

Outpatient cervical ripening with Foley

EXPERIMENTAL

Cervical ripening will begin with a Foley balloon in the outpatient setting

Device: Outpatient Foley catheter

Standard of care Inpatient cervical ripening

NO INTERVENTION

Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent

Interventions

Outpatient Foley catheter DEVICE

Outpatient Foley catheter placement for induction of labor

Outpatient cervical ripening with Foley

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (6)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

RECRUITING

Princeton Medical Center

Plainsboro, New Jersey, 08536, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Intermountain Health Utah Valley Hospital

Provo, Utah, 84604, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Study Officials

• Lisa Levine, MD, MSCE

  University of Pennsylvaina

  PRINCIPAL INVESTIGATOR

• Alison Cahill, MD, MSCI

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Levine, MD, MSCE

CONTACT

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

Meaghan McCabe, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Maternal Fetal Medicine

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 8, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: To be determined

Locations

US (6)