Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
University of Pennsylvania
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
- Age range
- 18–60 years
- Sex
- Female
- Healthy volunteers
- Yes
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…
Interventions
- DeviceOutpatient Foley catheter
Outpatient Foley catheter placement for induction of labor
Locations (6)
- Christiana Care Health Services, Inc.Newark, Delaware
- Princeton Medical CenterPlainsboro, New Jersey
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Texas at AustinAustin, Texas
- Intermountain Health Utah Valley HospitalProvo, Utah
- University of UtahSalt Lake City, Utah