Inpatient Versus Outpatient Foley Cervical Ripening Study

NCT ID: NCT03725397

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2022-06-27

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.

Conditions

Induced; Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Outpatients with a transcervical Foley catheter

Women with a transcervical Foley catheter in place that will spend the night at home.

Group Type: EXPERIMENTAL

Outpatient

Intervention Type: BEHAVIORAL

The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.

Inpatients with a transcervical Foley catheter

Women to be admitted to the hospital overnight which has been a "standard of care".

Group Type: ACTIVE_COMPARATOR

Inpatient

Intervention Type: BEHAVIORAL

Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

Interventions

Outpatient

The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.

Intervention Type: BEHAVIORAL

Inpatient

Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Kohari, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, United States

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32852803 (View on PubMed)

Other Identifiers

2000022710

Identifier Type: -

Identifier Source: org_study_id