Inpatient Versus Outpatient Foley Cervical Ripening Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:January 8, 2019
End Date:November 1, 2020
Contact:Olga Grechukhina, MD
Email:olga.grechukhina@yale.edu
Phone:203-688-2800

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

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.

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
We found this trial at
2
sites
1450 Chapel Street
New Haven, Connecticut 06511
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New Haven, CT
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New Haven, Connecticut 06520
Principal Investigator: Katherine Kohari, MD
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New Haven, CT
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