Inpatient Versus Outpatient Foley Cervical Ripening Study

Yale University

Status

Completed

Conditions

Induced; Birth

Treatments

Behavioral: Outpatient

Behavioral: Inpatient

Study type

Interventional

Funder types

Other

Identifiers

NCT03725397

2000022710

Details and patient eligibility

About

To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting

Full description

The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Indication for Induction of Labor is present
Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)
Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor
Cervical exam with Bishop Score <6
Intact membranes
Normal vital signs (blood pressure < 140/90, normal body temperature) at the time of presentation for Induction of Labor and within the last 24 hours
Maternal age ≥18 years of age

Exclusion criteria

Any contraindication for vaginal birth by institutional policy
Multiple gestation
History of cesarean delivery
Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm)
Rupture of membranes
Poorly controlled diabetes (Hgb A1C>8% and/or fingerstick glucose above target >50% of the time in the past week)
Poorly controlled chronic hypertension, gestational hypertension or preeclampsia (patient requiring IV antihypertensives within 4 hours of arrival)
Vaginal bleeding
Any conditions that require continuous electronic fetal monitoring either by institutional policy or provider determination (intrahepatic cholestasis of pregnancy, intrauterine growth restriction, abnormal non-stress test, others)
Fetal anomaly with anticipated neonatal intensive care unit admission
Fetal demise
HIV infection, presence of genital herpetic lesion
History of substance abuse during this pregnancy
History of precipitous delivery (delivery <3hrs from onset of labor)
Poor access to care (social, distance to hospital > 45 min, limited transportation)
Poor social situation, history of domestic violence, untreated/uncontrolled psychiatric condition
Inability to give informed consent, history of mental retardation
Strong preference for inpatient management
Inability to understand English or Spanish