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Clinical trialNCT05759988RecruitingInterventional

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

SponsorUniversity of PennsylvaniaEnrollment2,300Induction of Labor Affected Fetus / Newborn
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Christiana Care Health Services, Inc.

    Newark, Delaware, United States

    Anthony Sciscione, MDSuneet Chauhaun, MD
    Recruiting
  • Princeton Medical Center

    Plainsboro, New Jersey, United States

    Lisa D Levine, MD, MSCE
    Recruiting
  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    Lisa D Levine, MD, MSCE
    Recruiting
  • University of Texas at Austin

    Austin, Texas, United States

    Alison G Cahill, MD, MSCI
    Recruiting
  • Intermountain Health Utah Valley Hospital

    Provo, Utah, United States

    Jessica Page, MD
    Recruiting
  • University of Utah

    Salt Lake City, Utah, United States

    Robert M Silver, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
13 Apr 2023
Primary completion
30 Jun 2027
Completion
30 Jun 2027
Last update posted
2 Feb 2026
Registered enrollment
2,300
Registry id
NCT05759988

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.