Induction of LaborNCT05922111
Cervical Ripening Balloon for 12 Hours vs. 1 Hour.
A study testing cervical ripening balloon for one hour and cervical ripening balloon for twelve hours in people with Induction of Labor, run by Rambam Health Care Campus.
Trial summary
The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- cervical ripening balloon for one hour and cervical ripening balloon for twelve hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 2026
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous or multiparous gravidas
- Gestational age ≥ 370/7 to 416/7 gestational weeks
- Age 18-45
- Signed informed consent
Who cannot join
- Contraindications for vaginal delivery
- Multifetal gestation
- Rupture of membranes
- Bishop score > 6
- The cervix is dilated to more than 2 cm
- Previous caesarean delivery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.
Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
Read the detailed description
The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours.
Study Protocol:
- Women planned for induction of labor will be approached by a trained resident and will sign informed consent.
- All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.
- Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).
- Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
- Conditions
- Induction of Labor
- Being tested
- cervical ripening balloon for one hour, cervical ripening balloon for twelve hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical ripening balloon for one hourDevice
The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
cervical ripening balloon for twelve hoursDevice
The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
| Study group | Role | What they receive |
|---|---|---|
| cervical ripening balloon for 1 hour | Experimental | Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician Receives: Device: cervical ripening balloon for one hour |
| cervical ripening balloon for 12 hours | Active comparator | Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician Receives: Device: cervical ripening balloon for twelve 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 between balloon insertion to delivery
Measured: From date of balloon insertion until the date of delivery, assessed up to 4 days
Secondary outcomes (14)
to compare the mode of delivery
Mode of delivery
Measured: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the time to active and second stage of labor
Time to active and second stage of labor
Measured: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the rate of chorioamnionitis
Rate of chorioamnionitis
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of post-partum hemorrhage
Rate of post-partum hemorrhage and need for blood transfusion
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the need for blood transfusion
the need for blood transfusion
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of anal sphincter injuries
Rate of obstetric anal sphincter injuries
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the length of maternal hospital stay
Length of maternal hospital stay
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the overall satisfaction rate
Overall satisfaction using the Birth satisfaction scale questionnaire with higher score means a better outcome. minimal score 30, maximal score 150.
Measured: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the Apgar score between the groups
Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10.
Measured: at the date of delivery
To compare the rate of neonatal acidemia between the groups
Neonatal acidemia
Measured: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of admission to neonatal intensive care unit between the groups
Admission to neonatal intensive care unit
Measured: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of Respiratory complications between the groups
Respiratory complications
Measured: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of neonatal sepsis between the groups
Neonatal sepsis
Measured: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of birthweightbetween the groups
Birthweight in grams
Measured: at the date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be an open-label,1:1, randomized controlled trial.
- 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
- Sponsor
- Investigators
- Naphtali Justman, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922111
- Sponsor's protocol ID
- 0602-21-RMB CTIL
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol and informed consent form will be shared upon request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922111
- Acronym / sponsor ID
- 0602-21-RMB CTIL
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Jun 2023 (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 aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.
Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
Detailed description
The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours.
Study Protocol:
- Women planned for induction of labor will be approached by a trained resident and will sign informed consent.
- All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.
- Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).
- Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be an open-label,1:1, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| cervical ripening balloon for 1 hour | Experimental | Device: cervical ripening balloon for one hourEligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician |
| cervical ripening balloon for 12 hours | Active comparator | Device: cervical ripening balloon for twelve hoursEligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous or multiparous gravidas
- Gestational age ≥ 370/7 to 416/7 gestational weeks
- Age 18-45
- Signed informed consent
Key exclusion criteria (6 listed)
- Contraindications for vaginal delivery
- Multifetal gestation
- Rupture of membranes
- Bishop score > 6
- The cervix is dilated to more 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 |
|---|---|---|
| cervical ripening balloon for one hourThe cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room | Device | cervical ripening balloon for 1 hour |
| cervical ripening balloon for twelve hoursThe cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room | Device | cervical ripening balloon for 12 hours |
Primary outcome
insertion to delivery time interval
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
The time interval between balloon insertion to delivery
14 secondary outcomes
to compare the mode of delivery
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the time to active and second stage of labor
Time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days
to compare the rate of chorioamnionitis
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of post-partum hemorrhage
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the need for blood transfusion
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
to compare the rate of anal sphincter injuries
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the length of maternal hospital stay
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the overall satisfaction rate
Time frame: From date of balloon insertion until the date of discharge, assessed up to 8 days
To compare the Apgar score between the groups
Time frame: at the date of delivery
To compare the rate of neonatal acidemia between the groups
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of admission to neonatal intensive care unit between the groups
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of Respiratory complications between the groups
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of neonatal sepsis between the groups
Time frame: From date of delivery until the date of neonate discharge, assessed up to 14 days
To compare the rate of birthweightbetween the groups
Time frame: at the date of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No. Study protocol and informed consent form will be shared upon request from the corresponding author
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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.
Naphtali Justman principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing cervical ripening balloon for one hour and cervical ripening balloon for twelve hours in people with Induction of Labor, run by Rambam Health Care Campus.
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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Naphtali Justman (0546836644, njustman88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insertion to delivery time interval (time frame: From date of balloon insertion until the date of delivery, assessed up to 4 days). 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 28 Jun 2023.