Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Public ClinicalTrials.gov record NCT05759988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05759988
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2023
- Primary completion
- Jun 29, 2027
- Completion
- Jun 29, 2027
- Last update posted
- Feb 1, 2026
2023 – 2027
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Christiana Care Health Services, Inc. | Newark | Delaware | 19718 | Recruiting |
| Princeton Medical Center | Plainsboro | New Jersey | 08536 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Texas at Austin | Austin | Texas | 78712 | Recruiting |
| Intermountain Health Utah Valley Hospital | Provo | Utah | 84604 | Recruiting |
| University of Utah | Salt Lake City | Utah | 84112 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05759988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05759988 live on ClinicalTrials.gov.