NCT05257187

Brief Summary

The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction with oxytocin, a medication given to induce contractions. However, there is no clear timeline for when to remove the foley catheter or how long foley catheters can be safely kept in place. The study team's goal is to conduct a randomized controlled trial (RCT) in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for induction of labor to achieve vaginal delivery while shortening the overall length of labor. Based on our power analysis, the study team plans to enroll a total of 356 patients (218 nulliparous patients and 138 multiparous patients) over the course of 18 months. Then the study team will randomize patients to one of the following two groups: foley catheter removal after 6 hours or foley catheter removal after 12 hours. All patients will receive simultaneous pitocin and a foley catheter, and the remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The primary outcome will be time of foley catheter insertion to delivery. Secondary outcomes will be rates of cesarean delivery and obstetric/neonatal outcomes.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

February 16, 2022

Last Update Submit

November 14, 2023

Conditions

Labor Induction

Outcome Measures

Primary Outcomes (1)

  • Length of Labor

    Length of time from foley catheter insertion to delivery time in minutes at the time of infant delivery

    Day 1, at time of infant delivery

Secondary Outcomes (7)

  • Number of Cesarean delivery

    Day 1, at time of infant delivery

  • Number of Maternal Intrapartum Fever

    Day 1, at time of infant delivery

  • Number of Participants that require Intrapartum antibiotic administration

    Day 1, at time of infant delivery

  • Number of Participants with Postpartum Hemorrhage

    6 Days Postpartum

  • Number of NICU admission

    6 Days Postpartum

  • +2 more secondary outcomes

Study Arms (2)

6 hour foley catheter retention

ACTIVE COMPARATOR

Patients will have the foley catheter in place for up to 6 hours starting from insertion time to removal. If the catheter falls out earlier than the 6 hour mark, the patient will still be included for analysis.

Device: Transcervical foley catheter

12 hour foley balloon retention

PLACEBO COMPARATOR

Patients will have the foley catheter in place for up to 12 hours starting from insertion time to removal. If the catheter falls out earlier than the 12 hour mark, the patient will still be included for analysis.

Device: Transcervical foley catheter

Interventions

Transcervical foley catheterDEVICE

The foley catheter is inserted manually by an obstetric provider through the cervix and inflated with 60cc of saline. Once in the correct position, the catheter is inflated, which puts pressure on the cervix, allowing it to release hormones that soften the cervix and help the cervix to open. The foley catheter can be left in place up to 12 hours but typically will fall out when the cervix is dilated to 3-4 centimeters.

12 hour foley balloon retention6 hour foley catheter retention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 through 50 years old
  • Bishop score of 6 or less
  • Singleton pregnancies at 37 weeks or more
  • Absence of labor or rupture of membranes.

You may not qualify if:

  • COVID positive patients
  • Previous history of cesarean delivery
  • Ruptured membranes (the institutional policy states women cannot have foley catheters placed if membranes are ruptured)
  • Documented labor on admission (will include only patients being induced)
  • Fetal distress on admission (e.g. indication for induction of labor being category 2 tracing as these patients may have increased risk of cesarean delivery)
  • Certain fetal anomalies (e.g. brain anomalies, abdominal wall or neural tube defects, fetal cardiac arrhythmias)
  • Contraindication to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

Related Publications (2)

  • Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804.

    PMID: 32282603BACKGROUND

  • Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.

    PMID: 33771496BACKGROUND

Study Officials

  • Lois Brustman, MD

    Icahn School of Medicine at Mount Sinai

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study team will randomize patients to one of the following two groups: foley balloon removal after 6 hours or foley balloon removal after 12 hours. All patients will receive simultaneous pitocin and foley balloon. The remainder of the induction course (i.e. rupture of membranes, etc.) will be left to the discretion of the obstetric provider. The study is intention-to-treat meaning that if the foley balloon falls out earlier than the 6 hour or the 12 hour mark, the patient will still be included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Obstetrics, Gynecology and Reproductive Science

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

November 7, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Immediately following publication. No end date.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US(1)