Labor InductionNCT07689357
Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
A study testing Cook Cervical Ripening Balloon 3 hours and Cook Cervical Ripening Balloon 12 hours in people with Labor Induction and Cervical Ripening and Induction of Labor, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Induction, Cervical Ripening and Induction of Labor
- What is being tested?
- Cook Cervical Ripening Balloon 3 hours and Cook Cervical Ripening Balloon 12 hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteIsrael
- Study dates
- 27 May 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous or multiparous pregnant women.
- Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
- Maternal age between 18 and 45 years.
- Participant has provided signed informed consent.
Who cannot join
- Presence of any contraindications for vaginal delivery.
- Multifetal gestation.
- Rupture of membranes prior to balloon insertion.
- Favorable cervix, defined as a Bishop score greater than 6.
- Cervical dilation greater than 2 cm.
- Previous cesarean delivery or any other prior major uterine surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31906
Bar Rosh, MD, +972- 4-777-1779, b_rosh@rmc.gov.il
About this study
Official title: Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.
The main questions it aims to answer are:
Read more
Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?
Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?
Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.
Participants will:
Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).
Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.
Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.
Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.
Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.
- Being tested
- Cook Cervical Ripening Balloon 3 hours, Cook Cervical Ripening Balloon 12 hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Cervical Ripening Balloon 3 hoursDevice
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours.
Cook Cervical Ripening Balloon 12 hoursDevice
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| 3 hours balloon group | Experimental | Double-balloon cervical ripening catheter inserted and left in place for 3 hours before removal Receives: Device: Cook Cervical Ripening Balloon 3 hours |
| 12 hours balloon group | Active comparator | Double-balloon cervical ripening catheter inserted and left in place for 12 hours before removal Receives: Device: Cook Cervical Ripening Balloon 12 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion-to-Delivery Time Interval
The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).
Measured: From the time of balloon insertion up to delivery (approximately 48 hours).
Secondary outcomes (5)
Mode of Delivery
The rates of successful vaginal deliveries, instrumental deliveries (vacuum), and cesarean deliveries between the two groups.
Measured: At the time of delivery.
Time to Active Phase and Second Stage of Labor
The duration (in hours) from balloon insertion to the onset of the active phase of labor, and the duration of the second stage of labor.
Measured: From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.
Maternal Complications
Composite rate of maternal complications including chorioamnionitis, postpartum hemorrhage (PPH, defined as estimated blood loss greater than 1000 mL), need for blood transfusion, maternal fever during or after delivery, and obstetric anal sphincter injuries (OASIS).
Measured: From balloon insertion up to 48 hours postpartum.
Adverse Neonatal Outcomes
Composite rate of neonatal outcomes including birthweight, Apgar scores at 1 and 5 minutes (range 0-10; higher scores indicate better neonatal condition), neonatal umbilical cord pH, rates of respiratory complications, admission to the Neonatal Intensive Care Unit (NICU), and suspected or confirmed neonatal sepsis.
Measured: From birth up to newborn discharge or 7 days of life.
Duration of Hospitalization
The total length of maternal hospital stay (in days) from the day of admission for labor induction to the day of postpartum discharge.
Measured: From admission for induction up to hospital discharge (approximately 3-5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start27 May 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bar Rosh MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689357
- Sponsor's protocol ID
- 0602-21-RMB
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT07689357
- Acronym / sponsor ID
- 0602-21-RMB
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- 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.
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.
The main questions it aims to answer are:
Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?
Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?
Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.
Participants will:
Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).
Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.
Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.
Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.
Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 hours balloon group | Experimental | Device: Cook Cervical Ripening Balloon 3 hoursDouble-balloon cervical ripening catheter inserted and left in place for 3 hours before removal |
| 12 hours balloon group | Active comparator | Device: Cook Cervical Ripening Balloon 12 hoursDouble-balloon cervical ripening catheter inserted and left in place for 12 hours before removal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous or multiparous pregnant women.
- Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
- Maternal age between 18 and 45 years.
- Participant has provided signed informed consent.
Key exclusion criteria (6 listed)
- Presence of any contraindications for vaginal delivery.
- Multifetal gestation.
- Rupture of membranes prior to balloon insertion.
- Favorable cervix, defined as a Bishop score greater than 6.
- Cervical dilation greater than 2 cm.
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 |
|---|---|---|
| Cook Cervical Ripening Balloon 3 hoursUse of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours. | Device | 3 hours balloon group |
| Cook Cervical Ripening Balloon 12 hoursUse of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours. | Device | 12 hours balloon group |
Primary outcome
Insertion-to-Delivery Time Interval
Time frame: From the time of balloon insertion up to delivery (approximately 48 hours).
The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).
5 secondary outcomes
Mode of Delivery
Time frame: At the time of delivery.
Time to Active Phase and Second Stage of Labor
Time frame: From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.
Maternal Complications
Time frame: From balloon insertion up to 48 hours postpartum.
Adverse Neonatal Outcomes
Time frame: From birth up to newborn discharge or 7 days of life.
Duration of Hospitalization
Time frame: From admission for induction up to hospital discharge (approximately 3-5 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook Cervical Ripening Balloon 3 hours and Cook Cervical Ripening Balloon 12 hours in people with Labor Induction and Cervical Ripening and Induction of Labor, run by Rambam Health Care Campus 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion-to-Delivery Time Interval (time frame: From the time of balloon insertion up to delivery (approximately 48 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.