Inpatient Versus Outpatient Foley Cervical Ripening Study

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

Study Overview

• Status: Completed
• Conditions: Induced; Birth
• Intervention / Treatment: Behavioral: Outpatient; Behavioral: Inpatient

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital, York Street Campus
    • New Haven, Connecticut, United States, 06511
      • Yale New Haven Hospital- St. Raphael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatients with a transcervical Foley catheter; Women with a transcervical Foley catheter in place that will spend the night at home.	Behavioral: Outpatient; The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
Active Comparator: Inpatients with a transcervical Foley catheter; Women to be admitted to the hospital overnight which has been a "standard of care".	Behavioral: Inpatient; Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Foley catheter extrusion	Antepartum time of Foley catheter extrusion before patient being brought to labor	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bishop score	Bishop scoring system used to consider having cervical ripening.Women with favorable cervices (BS 8 or more) are considered to have a cervix ripe and ready to proceed to induction. BS <6 are considered unripe, and therefore may benefit from additional ripening modalities	during labor
Total time in cervical ripening	Measure of total time in cervical ripening	from labor induction to delivery time
Total time slept during pre-induction	Total time slept during pre-induction	during labor
Total time in hospital	Total time in hospital	no max but an average of 3 days
Analgesia used during pre-induction	Analgesia used during pre-induction	within 24 hours before Pitocin initiation
Use of oxytocin	Pitocin is given as a continuous infusion and the dose is titrated according to the contraction pattern (goal max contractions but not hyperstimulation). We will calculate the total time of Pitocin infusion as well as total dose (rate of infusion x time).	3 days
Fever over 38 degrees C	Did the patient have a fever over 38 degrees C	within 7 days of Foley placement
Neonatal Intensive Care Unit (NICU)	Was the baby admitted to NICU	within 7 days of Foley placement
APGAR scores	Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.	1 minute of life
APGAR scores	Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.	5 minutes of life
Hospital charges	All patients will be charged. We are hoping to see lower charges for women in the Out Patient group.	within 30 days after discharge

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Katherine Kohari, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2000022710

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No