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

University of Pennsylvania

Status: Enrolling

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Device: Outpatient Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05759988

851906

Details and patient eligibility

About

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.

Enrollment: 2,300 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,300 participants in 2 patient groups

Outpatient cervical ripening with Foley

Experimental group

Description:

Cervical ripening will begin with a Foley balloon in the outpatient setting

Treatment:

Device: Outpatient Foley catheter

Standard of care Inpatient cervical ripening

No Intervention group

Description:

Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent