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

Last updated: March 3, 2019
Sponsor: Bnai Zion Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03045939
BNZ-0115-16
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 intactmembranes, and no significant regular uterine contraction at gestational age of 37completed gestational weeks or more.

  5. Willingness to comply with the protocol for the duration of the study.

  6. Have signed the informed consent.

Exclusion

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 Design

Total Participants: 200
Study Start date:
March 01, 2017
Estimated Completion Date:
March 01, 2019

Study 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.

Connect with a study center

  • Bnai Zion Mc

    Haifa,
    Israel

    Active - Recruiting

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