PregnancyPhase 2/3NCT02196103
Management of Labor in Patients With Previous Cesarian Section
A Phase 2/3 study testing Double balloon cervical catheter in people with Pregnancy and Previous Cesarian Section, run by Hillel Yaffe Medical Center.
Trial summary
Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Previous Cesarian Section, Premature Rupture of Membranes (PROM)
- What is being tested?
- Double balloon cervical catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2018
- Phase
- Phase 2/3
- 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
- Diagnosed to be pregnant with PROM at >34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
- Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
- Found to have an unripe cervix in a speculum examination.
- Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
- Previous on cesarian section.
- Willingness to comply with the protocol for the duration of the study.
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- Have signed an informed consent.
- Exclusion Criteria: Patients having any of the following conditions:
- Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
- Regular uterine contractions (3-5/10 min).
- Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.
- Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC>/=20,000)
- Suspected placental abruption or presence of a significant hemorrhage.
- Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Asnat Walfisch, MD contact
About this study
Official title: Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study
Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.
- Being tested
- Double balloon cervical catheter
- Keywords
- TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double balloon cervical catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Expectant management | Experimental | Not described Receives: Device: Double balloon cervical catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal delivery rate
20% higher vaginal delivery rate
Measured: 48 hours
Secondary outcomes (1)
safety
safety of the double balloon device in women with one previous cesarian section and PROM at >/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Asnat Walfisch, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196103
- Sponsor's protocol ID
- 0019-14-HYMC
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02196103
- Acronym / sponsor ID
- 0019-14-HYMC
- Keywords
- TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 21 Jul 2014 (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.
Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expectant management | Experimental | Device: Double balloon cervical catheter |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Diagnosed to be pregnant with PROM at >34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
- Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
- Found to have an unripe cervix in a speculum examination.
- Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
- Previous on cesarian section.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Double balloon cervical catheter | Device | Expectant management |
Primary outcome
vaginal delivery rate
Time frame: 48 hours
20% higher vaginal delivery rate
1 secondary outcome
safety
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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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.
Asnat Walfisch, MD contact
Asnat Walfisch, MD principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Double balloon cervical catheter in people with Pregnancy and Previous Cesarian Section, run by Hillel Yaffe Medical Center.
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 14 inclusion and 0 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 21 Jul 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Asnat Walfisch, MD (050-4492200), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal delivery rate (time frame: 48 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 NCT02196103, which also lists 1 linked publication.
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 21 Jul 2014.