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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: Recruiting NA study of Induction of Labor Affected Fetus / Newborn, sponsored by University of Pennsylvania.
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, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine 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 |
What NCT05759988 shows while recruiting
NCT05759988 is an interventional study that assigns participants to a tested intervention. Its 2,300 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% higher).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT05759988's enrollment target sits among peer trials
2,300 46th of 2000 higher than 1,953 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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