Trials / Recruiting
RecruitingNCT05759988
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,300 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Outpatient Foley catheter | Outpatient Foley catheter placement for induction of labor |
Timeline
- Start date
- 2023-04-13
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
- First posted
- 2023-03-08
- Last updated
- 2026-02-02
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05759988. Inclusion in this directory is not an endorsement.