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NCT05759988 · ClinicalTrials.gov registry record · NA
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
A NA study of Induction of Labor Affected Fetus / Newborn, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 2,300
- Enrollment target
- 6
- Study locations
NCT05759988 is a NA study of Induction of Labor Affected Fetus / Newborn that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 2,300 participants. The trial reports 6 study locations across 5 states.
The verdict
NCT05759988, a NA study of Induction of Labor Affected Fetus / Newborn, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,300 participants
- Enrollment target
- 6
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 2,300 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. 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 1,423 total studies on file at ClinicalTrials.gov.
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.
NCT05759988 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Utah, Delaware, New Jersey.
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.
What interventions are being tested in trial NCT05759988?
The interventions under investigation include: Outpatient Foley catheter (DEVICE).
Who is sponsoring clinical trial NCT05759988?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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.
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