RecruitingNot ApplicableNCT05759988

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

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


Sponsor

University of Pennsylvania

Enrollment

2,300 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Outpatient Foley catheter for people with induction of labor affected fetus / newborn. The study is currently recruiting participants at 6 locations. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOutpatient 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

View Full Details on ClinicalTrials.gov

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NCT05759988


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