Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Pennsylvania
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Outpatient Foley catheter
DeviceOutpatient Foley catheter placement for induction of labor
Treatment groups
2,300 Participants
are divided into 2 treatment groupsGroup A: Outpatient cervical ripening with FoleyExperimental treatment 1 intervention
Group B: Standard of care Inpatient cervical ripeningNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
At deliverySecondary outcomes
1
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
Time frame
Within 6 weeks of delivery2
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
Time frame
From time of delivery to discharge from hospital, up to 6 weeks from delivery3
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
Time frame
Within 6 weeks of delivery4
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
Time frame
From time of delivery to discharge from hospital, up to 6 weeks from deliveryOther outcomes
1
Heterogeneity of Treatment Effect/prespecified sub-groups
Pre-specified subgroups to be included are: Starting cervical dilation (\<1cm vs. \>=1cm), Bishop score (\<6 vs. \>=6), BMI (\<30 kg/m2 vs. \>=30 kg/m2), Race/ethnicity (Black, White, Asian, Other; Hispanic/Non-Hispanic), Gestational age at start of induction (37-39w6d vs. \>=40 weeks), Advanced Maternal Age (AMA) (\>=35 yo) vs not AMA (\<35 yo)
Time frame
within 6 weeks of deliverySponsors and contacts
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Source ClinicalTrials.gov