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

January 29, 2026 updated by: Lisa Levine, University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
    • Pennsylvania
    • Texas
      • Austin, Texas, United States, 78712
    • Utah
      • Provo, Utah, United States, 84604
        • Recruiting
        • Intermountain Health Utah Valley Hospital
        • Contact:
        • Principal Investigator:
          • Jessica Page, MD
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Cesarean Delivery
Time Frame: At 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal morbidity incidence
Time Frame: Within 6 weeks of delivery
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)
Time Frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
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
Time Frame: Within 6 weeks of delivery
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
Time Frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heterogeneity of Treatment Effect/prespecified sub-groups
Time Frame: within 6 weeks of delivery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Levine, MD, MSCE, University of Pennsylvaina
  • Principal Investigator: Alison Cahill, MD, MSCI, University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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