Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor

NACompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

January 29, 2025

Study Completion Date

January 29, 2025

Conditions
Induction of Labor Affected Fetus / NewbornCervical RipeningPatient Satisfaction
Interventions
OTHER

Outpatient Cervical Ripening

The experimental arm of the study will be subjects randomized to the outpatient group. Once randomized, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with outpatient induction of labor. Following placement of the Foley catheter, the subjects will be given detailed instructions for which to return to the hospital, as well as provided a 24 hour phone number to call if they have questions. They will be instructed to return to the hospital once the catheter falls out or if 24 hours has passed since its placement. Upon returning to the hospital, subjects will complete another survey assessing their satisfaction with their induction process.

OTHER

Inpatient Cervical Ripening

Once randomized to this group, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with inpatient induction of labor. Following placement of the Foley catheter, the subjects will undergo normal labor monitoring until their Foley catheter either falls out or is removed at 24 hours. At this time subjects will complete another survey assessing their satisfaction with their induction process.

PROCEDURE

Foley catheter placement

Subjects randomized to both the inpatient and the outpatient arms will receive this intervention following completion of a survey. A Bard(TM) 16G two-way 5cc silicone-coated latex Foley catheter will be placed by a physician-member of the research team using a sterile metal speculum and ring forceps, or by hand, depending on physician preference. Once placed within the cervical canal, the Foley will be filled with 60cc of saline

BEHAVIORAL

Pre-Foley Questionnaire

Prior to randomization into inpatient or outpatient arms, all subjects will complete a questionnaire assessing their attitudes, opinions, fears and anxiety regarding induction of labor.

BEHAVIORAL

Post-Foley Questionnaire

Following removal of the Foley catheter (either by a physician at 24 hours or spontaneously), all subjects will complete the same questionnaire as prior assessing their attitudes, opinions, fears and anxiety regarding their induction of labor.

PROCEDURE

Fetal Non-Stress Test

Following placement of the Foley catheter, all subjects, regardless of arm they are randomized to, will undergo a 20-minute NST. The NST will be read by a physician-member of the research team. If the NST is considered to be suspicious based on the physician's evaluation, subjects randomized to the outpatient arm will be moved to the inpatient arm, but evaluated as part of the outpatient arm on an intent-to-treat basis. All subjects randomized to the inpatient arm will be placed on continuous fetal heart rate monitoring, regardless of physician evaluation of the NST.

Trial Locations (1)

90806

Miller Women's and Children's Hospital Long Beach, Long Beach

All Listed Sponsors
lead

MemorialCare Health System

OTHER

NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor | Biotech Hunter | Biotech Hunter