NCT03725397

Inpatient Versus Outpatient Foley Cervical Ripening Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Outpatient	The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
BEHAVIORAL	Inpatient	Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

Timeline

• Start date: 2019-01-08
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2018-10-31
• Last updated: 2023-02-22

Locations

2 sites across 1 country: United States