Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2019-12-01
2021-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Cerclage 1
Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1
Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 2
Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2
Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 3
Between 38-38.6 weeks' gestation - group 3
Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 4
Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4
Cervical cerclage
Cervical cerclage and cervical cerclage removal
Interventions
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Cervical cerclage
Cervical cerclage and cervical cerclage removal
Eligibility Criteria
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Inclusion Criteria
* Elective or emergent cerclage in the current pregnancy
* Cerclage that was removed after 36 weeks of pregnancy
Exclusion Criteria
* Major congenital anomalies
* Cerclage removal before 36weeks of pregnancy
18 Years
45 Years
FEMALE
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Yaniv Zipori MD
Principal Investigator
Principal Investigators
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Yaniv Zipori, M.D
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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Central Contacts
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Other Identifiers
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0410-19-RMB
Identifier Type: -
Identifier Source: org_study_id
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