Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
University of Pennsylvania
2,300 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria14
- 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
- Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course
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Interventions
Outpatient Foley catheter placement for induction of labor
Locations(6)
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NCT05759988