Effectiveness of Cervico-isthmic Cerclage (CERCEI LB)

December 21, 2021 updated by: Hospices Civils de Lyon

Effectiveness of CERvico-isthmic CErclage in Increasing the Rate of Live Births in Case of a History of Late Miscarriage and/or Premature Delivery

This study compares the rate of live births before and after cervico-isthmic cerclage in 3 hospitals in the last 10 years. The hypothesis is that cerclage significantly increases the rate of live births in women with cervical insufficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

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

  • France
      • Bron, France, 69500
        • Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse - Hospices Civils de Lyon
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who have had cervico-isthmic cerclage between January 1, 2010 and April 1, 2019, in 3 University Hospitals of Lyon (Lyon Sud Hospital, HFME Hospital and Croix-Rousse Hospital).

Description

Inclusion Criteria:

  • History of premature delivery or late miscarriage unrelated to maternal pathology, chorioamnionitis, fetal or placental pathology
  • Patient aged over 18 at the time of the phone call
  • Cerclage performed according to the Benson technique verified on the operative report
  • Cerclage performed in one of the 3 obstetric gynecology departments of the CHU de Lyon (Lyon Sud, Croix Rousse and HFME) between January 1, 2010 and April 1, 2019

Exclusion Criteria:

  • History of trachelectomy
  • Surgical technique not specified or not deductible from the operating report
  • Refusal to participate in the study
  • Patient under legal protection

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervico-isthmic cerclage
Are included in this group the women who underwent cervico-isthmic cerclage between January 1, 2010 and April 1, 2019, in 3 hospitals of the Hospices Civils de Lyon, respecting the inclusion and exclusion criteria, to assess the primary and secondary outcomes before and after performing the cerclage.
Procedure: Cervico-isthmic cerclage
There is no intervention in this study. It's an observational retrospective study, before/after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of live birth ≥ 24 weeks of gestation or before 24 weeks of gestation with active neonatal intensive care, among pregnancies progressing after 14 weeks of gestation.
Time Frame: Day 0 (At Inclusion)
We collect the data necessary to assess the outcomes in the medical charts. When data is missing, we will call patients (telephone interview) and ask them a few questions related to their gynecological and obstetric history.
Day 0 (At Inclusion)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: DEBORAH GAVANIER, MD, Service de gynécologie-obstétrique - Centre hospitalier Lyon sud

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 (ACTUAL)

June 13, 2021

Primary Completion (ACTUAL)

December 11, 2021

Study Completion (ACTUAL)

December 11, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (ACTUAL)

January 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_1088
  • 2020-A03187-32 (OTHER: ID-RCB)

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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