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RECRUITING
NCT05759988
NA

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

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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.

Official title: Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

2300

Start Date

2023-04-13

Completion Date

2027-06-30

Last Updated

2026-02-02

Healthy Volunteers

Yes

Interventions

DEVICE

Outpatient Foley catheter

Outpatient Foley catheter placement for induction of labor

Locations (6)

Christiana Care Health Services, Inc.

Newark, Delaware, United States

Princeton Medical Center

Plainsboro, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas at Austin

Austin, Texas, United States

Intermountain Health Utah Valley Hospital

Provo, Utah, United States

University of Utah

Salt Lake City, Utah, United States