The Optimal Timing for Cerclage Removal

November 2, 2019 updated by: Yaniv Zipori MD, Rambam Health Care Campus
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

- Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cerclage 1
Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1
Procedure: Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 2
Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2
Procedure: Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 3
Between 38-38.6 weeks' gestation - group 3
Procedure: Cervical cerclage
Cervical cerclage and cervical cerclage removal
Cerclage 4
Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4
Procedure: Cervical cerclage
Cervical cerclage and cervical cerclage removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cercalge removal and neonatal morbidity
Time Frame: 1 year
Neonatal respiratory morbidity after cerclage removal
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The optimal timing for cerclage removal
Time Frame: 1 year
Time interval between cerclage removal and gestational age of delivery.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yaniv Zipori, M.D, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0410-19-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Yet undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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