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RECRUITING NA

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

NCT05759988 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE Outpatient Foley catheter

Study Locations (6)

Utah

  • Intermountain Health Utah Valley Hospital — Provo
  • University of Utah — Salt Lake City

Delaware

  • Christiana Care Health Services, Inc. — Newark

New Jersey

  • Princeton Medical Center — Plainsboro

Pennsylvania

  • University of Pennsylvania — Philadelphia

Texas

  • University of Texas at Austin — Austin

Trial Details

FieldValue
Enrollment Target 2,300 participants
Start Date 2023-04-13
Est. Completion 2027-06-30
Phase NA

Sponsor

University of Pennsylvania

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05759988

The ClinicalTrials.gov registry entry for NCT05759988 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Induction of Labor Affected Fetus / Newborn appearing as the primary indexed condition, and to 1 intervention — of which Outpatient Foley catheter is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05759988 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Utah, Delaware, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05759988 about?

NCT05759988 is a clinical study titled "Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)". 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 cervi...

What is the current status of trial NCT05759988?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,300 participants. The study started on 2023-04-13. Estimated completion is 2027-06-30.

What conditions does trial NCT05759988 study?

This clinical trial studies the following conditions: Induction of Labor Affected Fetus / Newborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05759988?

The interventions under investigation include: Outpatient Foley catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05759988?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05759988 being conducted?

This trial has 6 study locations across Delaware, New Jersey, Pennsylvania, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial