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

Study Overview
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Brief Summary
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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
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Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Device: Outpatient Foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Eligible for induction of labor Live singleton gestation ≥37 weeks and <42 weeks Nulliparous, ≥18 years of age with no previous deliveries >20 weeks Cephalic presentation Intact membranes Bishop score ≤8 and cervical dilation <3 cm English or Spanish speaking (Able to read/understand consent and instructions) Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter Exclusion Criteria Known oligohydramnios (DVP <2cm) Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery) Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10 Vaginal bleeding or concern for/known abruption prior to Foley placement Chorioamnionitis Any fetal growth restriction Preeclampsia with severe features Severe chronic hypertension Type 1 diabetes or poorly controlled pre-gestational diabetes Sickle cell disease Major fetal anomaly Women on therapeutic anticoagulation Decreased fetal movement HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria) Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient cervical ripening with Foley<br>Cervical ripening will begin with a Foley balloon in the outpatient setting | Device: Outpatient Foley catheter<br>* Outpatient Foley catheter placement for induction of labor<br>|
| No Intervention: Standard of care Inpatient cervical ripening<br>Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cesarean Delivery | Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal morbidity incidence | 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 | Within 6 weeks of delivery | 
| Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) | Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction | From time of delivery to discharge from hospital, up to 6 weeks from delivery | 
| Neonatal morbidity incidence | 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 | Within 6 weeks of delivery | 
| Maternal patient perception of control | Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control | From time of delivery to discharge from hospital, up to 6 weeks from delivery | 
| Maternal overall length of stay | Measured by hours from admission to postpartum discharge | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | 
| Maternal postpartum length of stay | Measured by hours from delivery to postpartum discharge | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | 
| Neonatal length of stay | Length of stay from birth to discharge, measured in hours | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | 
| NICU admission | Admission to neonatal intensive care unit | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | 
| NICU stay greater than 48 hours | Admission to the NICU for more than 48 hours | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | 
| Perceived stress scale-10 questions | A validated 10 question scale evaluating perceived stress | From time of delivery to discharge from hospital, up to 6 weeks from delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley balloon catheter, Outpatient cervical ripening