Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours (DoubleCRIB)

March 3, 2019 updated by: Inna.bleicher, Bnai Zion Medical Center

Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial

This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled study is designed to:

  1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
  2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups

200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours.

Each patient will sign an informed consent.

The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed.

After confirming eligibility for study, randomization into the following groups will take place.

Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.

Study Type

Interventional

Enrollment (Anticipated)

200

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

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Bnai Zion Mc
        • Contact:
          • INNA BLEICHER, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Parous patients 18 years of age or older.
  2. Diagnosed to be parous pregnant women with an indication for induction of labour.
  3. Having a Bishop score of 5 or less.
  4. Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.
  5. Willingness to comply with the protocol for the duration of the study.

  6. Have signed the informed consent.

    -

Exclusion Criteria:

  1. A non -vertex presentation
  2. Placenta previa
  3. Ruptured membranes
  4. Documented labour
  5. Foetal distress necessitating immediate intervention
  6. Proven malignancy of the cervix
  7. Active inflammatory or purulent condition of the lower genital tract
  8. Twin pregnancy
  9. Any other contraindication for vaginal 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 12 hours
This arm is the standard management that includes insertion of the DBD into the cervical canal according to manufacture guidelines, removal after 12 hours followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h)
Device: cervical ripening device
insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above
Other Names:
  • atad double balloon device
Active Comparator: 6 hours
Removal of the DBD after 6 hours, followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h)
Device: cervical ripening device
insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above
Other Names:
  • atad double balloon device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time from insertion of the DBD to delivery
Time Frame: minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours
the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes
minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of vaginal delivery
Time Frame: 1 year
calculation of the rate of vaginal delivery in each arm will be calculated by number of Vaginal deliveries in each arm and the percentage.
1 year
maternal and neonatal adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2017

Primary Completion (Actual)

February 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

February 4, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 3, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BNZ-0115-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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