Inpatient Versus Outpatient Foley Cervical Ripening Study
Completed · Not applicable
Conditions studied: Induced; Birth
In brief
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
Key facts
- Study ID
- NCT03725397
- Run by
- Yale University
- People needed
- 54
- Starts
- 2019-01-08
- Expected to finish
- 2022-06-27
- Last updated by the study team
- 2023-02-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale New Haven Hospital- St. Raphael — New Haven, Connecticut, United States
- Yale New Haven Hospital, York Street Campus — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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