Clinical trial NCT03045939: Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours
Official title: Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of Labor
Unfavorable Cervix
Keywords: cervical ripening
labor induction
double balloon device
cervical ripening device
unfavorable cervix
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-02-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

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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

Primary outcomes:
measure: time from insertion of the DBD to delivery
timeFrame: minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours
Secondary outcomes:
measure: rate of vaginal delivery
timeFrame: 1 year
measure: maternal and neonatal adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Mc
Study officials:
References:
citation: Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804.