Respiratory Disease of A NewbornNCT04151303
The Optimal Timing for Cerclage Removal
An observational study of Respiratory Disease of A Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. 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
- Respiratory Disease of A Newborn
- What is being tested?
- Cervical cerclage
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2019to 1 Jan 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: - Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.
Who may be able to join
- Singleton pregnancies
- Elective or emergent cerclage in the current pregnancy
- Cerclage that was removed after 36 weeks of pregnancy
Who cannot join
- Multiple pregnancies
- Major congenital anomalies
- Cerclage removal before 36weeks of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery
Read the detailed description
The optimal timing of cervical cerclage removal is yet unclear.
In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/
Primary outcome:
Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).
Secondary outcomes:
Time interval between cerclage removal and gestational age of delivery.
- Conditions
- Respiratory Disease of A Newborn
- Being tested
- Cervical cerclage
- Keywords
- RDS, CERCLAGE, CERVIX INSUFFICIENCY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical cerclageProcedure or surgery
Cervical cerclage and cervical cerclage removal
| Study group | Role | What they receive |
|---|---|---|
| Cerclage 1 | Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1 Receives: Procedure: Cervical cerclage | |
| Cerclage 2 | Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2 Receives: Procedure: Cervical cerclage | |
| Cerclage 3 | Between 38-38.6 weeks' gestation - group 3 Receives: Procedure: Cervical cerclage | |
| Cerclage 4 | Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4 Receives: Procedure: Cervical cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cercalge removal and neonatal morbidity
Neonatal respiratory morbidity after cerclage removal
Measured: 1 year
Secondary outcomes (1)
The optimal timing for cerclage removal
Time interval between cerclage removal and gestational age of delivery.
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 posted5 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Disease of A 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaniv Zipori MD, Rambam Health Care Campus
- Investigators
- Yaniv Zipori, M.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151303
- Sponsor's protocol ID
- 0410-19-RMB
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Timing for Cerclage Removal
- ClinicalTrials.gov ID
- NCT04151303
- Acronym / sponsor ID
- 0410-19-RMB
- Conditions
- Respiratory Disease of A Newborn
- Keywords
- RDS, CERCLAGE, CERVIX INSUFFICIENCY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 5 Nov 2019 (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 with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery
Detailed description
The optimal timing of cervical cerclage removal is yet unclear.
In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/
Primary outcome:
Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).
Secondary outcomes:
Time interval between cerclage removal and gestational age of delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cerclage 1 | – | Procedure: Cervical cerclageTime to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1 |
| Cerclage 2 | – | Procedure: Cervical cerclageTime to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2 |
| Cerclage 3 | – | Procedure: Cervical cerclageBetween 38-38.6 weeks' gestation - group 3 |
| Cerclage 4 | – | Procedure: Cervical cerclageTime to delivery after cerclage removal Beyond 39 weeks' gestation - group 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.
Key inclusion criteria (3 listed)
- Singleton pregnancies
- Elective or emergent cerclage in the current pregnancy
- Cerclage that was removed after 36 weeks of pregnancy
Key exclusion criteria (3 listed)
- Multiple pregnancies
- Major congenital anomalies
- Cerclage removal before 36weeks of pregnancy
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 cerclageCervical cerclage and cervical cerclage removal | Procedure or surgery | Cerclage 1, Cerclage 2, Cerclage 3, Cerclage 4 |
Primary outcome
Cercalge removal and neonatal morbidity
Time frame: 1 year
Neonatal respiratory morbidity after cerclage removal
1 secondary outcome
The optimal timing for cerclage removal
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 Nov 2019.
- Individual participant dataSharing planned: Undecided. Yet undecided
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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.
Yaniv Zipori, M.D 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?
An observational study of Respiratory Disease of A 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: status not confirmed, as of the sponsor's last update on 5 Nov 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 Yaniv Zipori, M.D (+972 58 7966963, y_zipori@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cercalge removal and neonatal morbidity (time frame: 1 year). 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 5 Nov 2019.