Cervical Ripening Balloon for 12 Hours vs. 1 Hour.
Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
1 other identifier
interventional
164
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJune 28, 2023
June 1, 2023
2.4 years
November 27, 2022
June 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
insertion to delivery time interval
The time interval between balloon insertion to delivery
From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary Outcomes (14)
to compare the 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
From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the 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
From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the need for blood transfusion
From date of balloon insertion until the date of discharge, assessed up to 8 days
- +9 more secondary outcomes
Study Arms (2)
cervical ripening balloon for 1 hour
EXPERIMENTALEligible 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
cervical ripening balloon for 12 hours
ACTIVE COMPARATOREligible 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Nulliparous or multiparous gravidas
- Gestational age ≥ 370/7 to 416/7 gestational weeks
- Age 18-45
- Signed informed consent
You may not qualify if:
- Contraindications for vaginal delivery
- Multifetal gestation
- Rupture of membranes
- Bishop score \> 6
- The cervix is dilated to more than 2 cm
- Previous caesarean delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Naphtali Justman
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2022
First Posted
June 28, 2023
Study Start
August 1, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
Study protocol and informed consent form will be shared upon request from the corresponding author