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

Induction of Labor Clinical Trial

— DoubleCRIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03045939
• Other study ID #: BNZ-0115-16
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Bnai Zion Medical Center
• Contact: Inna Bleicher, Dr
• Phone: +972506268345
• Email: innakreinin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor
• Unfavorable Cervix

Intervention

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

Locations

Country	Name	City	State
Israel	Bnai Zion Mc	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time from insertion of the DBD to delivery	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	rate of vaginal delivery	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
Secondary	maternal and neonatal adverse events		1 year