Clinical trial NCT05759988: Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Official title: Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: Foley balloon catheter
Outpatient cervical ripening
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 2300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Cesarean Delivery
timeFrame: At delivery
Secondary outcomes:
measure: Maternal morbidity incidence
timeFrame: Within 6 weeks of delivery
measure: Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)
timeFrame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
measure: Neonatal morbidity incidence
timeFrame: Within 6 weeks of delivery
measure: Maternal patient perception of control
timeFrame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
measure: Maternal overall length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Maternal postpartum length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Neonatal length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: NICU admission
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: NICU stay greater than 48 hours
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Perceived stress scale-10 questions
timeFrame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Other outcomes:
measure: Heterogeneity of Treatment Effect/prespecified sub-groups
timeFrame: within 6 weeks of delivery
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Pennsylvaina
name: Lisa Levine, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Alison Cahill, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: