Induction of LaborDoubleCRIBNCT03045939
Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours
A study testing cervical ripening device in people with Induction of Labor and Unfavorable Cervix, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor, Unfavorable Cervix
- What is being tested?
- cervical ripening device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parous patients 18 years of age or older.
- Diagnosed to be parous pregnant women with an indication for induction of labour.
- Having a Bishop score of 5 or less.
- 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.
- Willingness to comply with the protocol for the duration of the study.
- Have signed the informed consent.
- -
Who cannot join
- A non -vertex presentation
- Placenta previa
- Ruptured membranes
- Documented labour
- Foetal distress necessitating immediate intervention
- Proven malignancy of the cervix
Show all 9Show fewer
- Active inflammatory or purulent condition of the lower genital tract
- Twin pregnancy
- Any other contraindication for vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This randomized controlled study is designed to:
- To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
- 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.
- Conditions
- Induction of Labor, Unfavorable Cervix
- Being tested
- cervical ripening device
- Keywords
- cervical ripening, labor induction, double balloon device, cervical ripening device, unfavorable cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical ripening deviceDevice
Also called atad double balloon 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
| Study group | Role | What they receive |
|---|---|---|
| 12 hours | Other | 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) Receives: Device: cervical ripening device |
| 6 hours | Active comparator | 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) Receives: Device: cervical ripening device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours
Secondary outcomes (2)
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.
Measured: 1 year
maternal and neonatal adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion1 Feb 2019
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inna.bleicher, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045939
- Sponsor's protocol ID
- BNZ-0115-16
- Acronym
- DoubleCRIB
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sammour R, Dikopoltsev E, Sagi S, Vitner D, Bleicher I. Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial. Int J Gynaecol Obstet. 2025 Mar;168(3):1055-1059. doi: 10.1002/ijgo.15955. Epub 2024 Oct 24.
PubMed 39445570Bleicher 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.
PubMed 32282603
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT03045939
- Acronym / sponsor ID
- DoubleCRIB / BNZ-0115-16
- Conditions
- Induction of Labor, Unfavorable Cervix
- Keywords
- cervical ripening, labor induction, double balloon device, cervical ripening device, unfavorable cervix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 hours | Other | Device: cervical ripening deviceThis 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) |
| 6 hours | Active comparator | Device: cervical ripening deviceRemoval 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parous patients 18 years of age or older.
- Diagnosed to be parous pregnant women with an indication for induction of labour.
- Having a Bishop score of 5 or less.
- 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.
- Willingness to comply with the protocol for the duration of the study.
Key exclusion criteria (9 listed)
- A non -vertex presentation
- Placenta previa
- Ruptured membranes
- Documented labour
- Foetal distress necessitating immediate intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical ripening deviceAlso: atad double balloon deviceinsertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above | Device | 12 hours, 6 hours |
Primary outcome
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
2 secondary outcomes
rate of vaginal delivery
Time frame: 1 year
maternal and neonatal adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 39445570Sammour R, Dikopoltsev E, Sagi S, Vitner D, Bleicher I. Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial. Int J Gynaecol Obstet. 2025 Mar;168(3):1055-1059. doi: 10.1002/ijgo.15955. Epub 2024 Oct 24.
- Derived from this study: PubMed 32282603Bleicher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical ripening device in people with Induction of Labor and Unfavorable Cervix, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inna Bleicher, Dr (+972506268345, innakreinin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.