The Optimal Timing for Cerclage Removal

NCT ID: NCT04151303

Last Updated: 2019-11-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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

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Respiratory Disease of A Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

Cervical cerclage and cervical cerclage removal

Cerclage 2

Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2

Cervical cerclage

Intervention Type PROCEDURE

Cervical cerclage and cervical cerclage removal

Cerclage 3

Between 38-38.6 weeks' gestation - group 3

Cervical cerclage

Intervention Type PROCEDURE

Cervical cerclage and cervical cerclage removal

Cerclage 4

Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4

Cervical cerclage

Intervention Type PROCEDURE

Cervical cerclage and cervical cerclage removal

Interventions

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Cervical cerclage

Cervical cerclage and cervical cerclage removal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancies
* Elective or emergent cerclage in the current pregnancy
* Cerclage that was removed after 36 weeks of pregnancy

Exclusion Criteria

* Multiple pregnancies
* Major congenital anomalies
* Cerclage removal before 36weeks of pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Yaniv Zipori MD

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Israel

Central Contacts

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Yaniv Zipori, M.D

Role: CONTACT

+972 58 7966963

Other Identifiers

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0410-19-RMB

Identifier Type: -

Identifier Source: org_study_id

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