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

NCT05759988 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2026-02-02

No results posted yet for this study

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

Interventions

DEVICE

Outpatient Foley catheter

Outpatient Foley catheter placement for induction of labor

Sponsors & Collaborators

Principal Investigators

  • Lisa Levine, MD, MSCE · University of Pennsylvaina

  • Alison Cahill, MD, MSCI · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759988 on ClinicalTrials.gov