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

Not Applicable

Recruiting

• Conditions: Induction of Labor Affected Fetus / Newborn

• Registration Number: NCT05759988
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-08
• Study Start: 2023-04-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Cesarean Delivery	At delivery	Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening

Secondary Outcome Measures

Name	Time	Method
Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)	From time of delivery to discharge from hospital, up to 6 weeks from delivery	Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
Neonatal morbidity incidence	Within 6 weeks of delivery	Defined as a composite endpoint consisting of at least one incidence of the following outcomes: acidemia, respiratory failure/insufficiency, hypoxic-ischemic encephalopathy, treatment for hypoglycemia or suspected sepsis
Maternal morbidity incidence	Within 6 weeks of delivery	Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolis and hospital readmission with 6 weeks
Maternal patient perception of control	From time of delivery to discharge from hospital, up to 6 weeks from delivery	Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control
Maternal overall length of stay	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Measured by hours from admission to postpartum discharge
Maternal postpartum length of stay	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Measured by hours from delivery to postpartum discharge
Neonatal length of stay	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Length of stay from birth to discharge, measured in hours
NICU admission	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Admission to neonatal intensive care unit
NICU stay greater than 48 hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Admission to the NICU for more than 48 hours
Perceived stress scale-10 questions	From time of delivery to discharge from hospital, up to 6 weeks from delivery	A validated 10 question scale evaluating perceived stress

Trial Locations

Locations (4)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas at Austin; 🇺🇸 Austin, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States