Clinical trial NCT03725397: Inpatient Versus Outpatient Foley Cervical Ripening Study
Official title: Inpatient Versus Outpatient Foley Cervical Ripening Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two cohort double blinded clinical trial
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of Foley catheter extrusion
timeFrame: within 24 hours
Secondary outcomes:
measure: Bishop score
timeFrame: during labor
measure: Total time in cervical ripening
timeFrame: from labor induction to delivery time
measure: Total time slept during pre-induction
timeFrame: during labor
measure: Total time in hospital
timeFrame: no max but an average of 3 days
measure: Analgesia used during pre-induction
timeFrame: within 24 hours before Pitocin initiation
measure: Use of oxytocin
timeFrame: 3 days
measure: Fever over 38 degrees C
timeFrame: within 7 days of Foley placement
measure: Neonatal Intensive Care Unit (NICU)
timeFrame: within 7 days of Foley placement
measure: APGAR scores
timeFrame: 1 minute of life
measure: APGAR scores
timeFrame: 5 minutes of life
measure: Hospital charges
timeFrame: within 30 days after discharge
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital- St. Raphael
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital, York Street Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Katherine Kohari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.