Induction of Labor Affected Fetus / NewbornNCT04597333
Labor Induction After Failed Induction With Dinoprostone.
A study testing Dinoprostone and Cervical ripening balloon. in people with Induction of Labor Affected Fetus / Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Dinoprostone and Cervical ripening balloon.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2020to 31 Dec 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women after induction of labor with Dinoprostone.
- BISHOP score of under 5 after 1st induction attempt.
- Nulliparous women.
Who cannot join
- Women after induction of labor with a cervical ripening balloon.
- BISHOP score of over 5 after 1st induction attempt.
- Multiparous women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.
Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.
Read the detailed description
Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.
- Being tested
- Dinoprostone, Cervical ripening balloon.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
Dinoprostone vaginal insert.
Cervical ripening balloon.Device
Double lumen cervical ripening balloon.
| Study group | Role | What they receive |
|---|---|---|
| 2nd Dinoprostone. | Active comparator | Women induced with a second dinoprostone insert. Receives: Drug: Dinoprostone |
| Cervical ripening balloon. | Active comparator | Women induced with a cervical ripening balloon. Receives: Device: Cervical ripening balloon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery within 24 hours.
Rate of delivery in 24 hours.
Measured: From the time of induction up to 24 hours from induction.
Time to delivery.
The number of hours it takes to deliver.
Measured: From the time of induction up to 120 hours from induction.
Secondary outcomes (4)
Mode of delivery.
Vaginal and cesarean delivery rates.
Measured: From the time of induction up to 120 hours from induction.
Uterine revision.
The rate of uterine revision postpartum.
Measured: From the time of induction up to 120 hours from induction.
Postpartum hemorrhage.
The rate of postpartum hemorrhage.
Measured: From the time of induction up to 120 hours from induction.
Chorioamnionitis.
The rate of chorioamnionitis.
Measured: From the time of induction up to 120 hours from induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597333
- Sponsor's protocol ID
- 0009-20-RMB
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.
- ClinicalTrials.gov ID
- NCT04597333
- Acronym / sponsor ID
- 0009-20-RMB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Oct 2020 (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.
Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.
Detailed description
Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2nd Dinoprostone. | Active comparator | Drug: DinoprostoneWomen induced with a second dinoprostone insert. |
| Cervical ripening balloon. | Active comparator | Device: Cervical ripening balloon.Women induced with a cervical ripening balloon. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women after induction of labor with Dinoprostone.
- BISHOP score of under 5 after 1st induction attempt.
- Nulliparous women.
Key exclusion criteria (3 listed)
- Women after induction of labor with a cervical ripening balloon.
- BISHOP score of over 5 after 1st induction attempt.
- Multiparous women.
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 |
|---|---|---|
| DinoprostoneDinoprostone vaginal insert. | Drug | 2nd Dinoprostone. |
| Cervical ripening balloon.Double lumen cervical ripening balloon. | Device | Cervical ripening balloon. |
Primary outcome
Delivery within 24 hours.
Time frame: From the time of induction up to 24 hours from induction.
Rate of delivery in 24 hours.
Time to delivery.
Time frame: From the time of induction up to 120 hours from induction.
The number of hours it takes to deliver.
4 secondary outcomes
Mode of delivery.
Time frame: From the time of induction up to 120 hours from induction.
Uterine revision.
Time frame: From the time of induction up to 120 hours from induction.
Postpartum hemorrhage.
Time frame: From the time of induction up to 120 hours from induction.
Chorioamnionitis.
Time frame: From the time of induction up to 120 hours from induction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dinoprostone and Cervical ripening balloon. in people with Induction of Labor Affected Fetus / Newborn, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery within 24 hours. (time frame: From the time of induction up to 24 hours from induction.). The study lists 2 primary outcomes in all. 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 20 Apr 2022.