Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Device: Outpatient Foley catheter
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 2300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Outpatient cervical ripening with Foley Outpatient Foley catheter Cervical ripening will begin with a Foley balloon in the outpatient setting
- 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 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 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 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 Utah
🇺🇸Salt Lake City, Utah, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas at Austin
🇺🇸Austin, Texas, United States