Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

June 18, 2023 updated by: Rambam Health Care Campus

Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial

The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.

Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours.

Study Protocol:

  1. Women planned for induction of labor will be approached by a trained resident and will sign informed consent.
  2. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.
  3. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).
  4. Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Nulliparous or multiparous gravidas
  2. Gestational age ≥ 370/7 to 416/7 gestational weeks
  3. Age 18-45
  4. Signed informed consent

Exclusion Criteria:

  1. Contraindications for vaginal delivery
  2. Multifetal gestation
  3. Rupture of membranes
  4. Bishop score > 6
  5. The cervix is dilated to more than 2 cm
  6. Previous caesarean delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cervical ripening balloon for 1 hour
Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
Device: cervical ripening balloon for one hour
The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
Active Comparator: cervical ripening balloon for 12 hours
Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
Device: cervical ripening balloon for twelve hours
The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion to delivery time interval
Time Frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
The time interval between balloon insertion to delivery
From date of balloon insertion until the date of delivery, assessed up to 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare the mode of delivery
Time Frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
Mode of delivery
From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the time to active and second stage of labor
Time Frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
Time to active and second stage of labor
From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the rate of chorioamnionitis
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
Rate of chorioamnionitis
From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of post-partum hemorrhage
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
Rate of post-partum hemorrhage and need for blood transfusion
From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the need for blood transfusion
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
the need for blood transfusion
From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of anal sphincter injuries
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
Rate of obstetric anal sphincter injuries
From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the length of maternal hospital stay
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
Length of maternal hospital stay
From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the overall satisfaction rate
Time Frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
Overall satisfaction using the Birth satisfaction scale questionnaire with higher score means a better outcome. minimal score 30, maximal score 150.
From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the Apgar score between the groups
Time Frame: at the date of delivery
Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10.
at the date of delivery
To compare the rate of neonatal acidemia between the groups
Time Frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
Neonatal acidemia
From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of admission to neonatal intensive care unit between the groups
Time Frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
Admission to neonatal intensive care unit
From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of Respiratory complications between the groups
Time Frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
Respiratory complications
From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of neonatal sepsis between the groups
Time Frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
Neonatal sepsis
From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of birthweightbetween the groups
Time Frame: at the date of delivery
Birthweight in grams
at the date of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Naphtali Justman, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0602-21-RMB CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol and informed consent form will be shared upon request from the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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