Effectiveness of Cervico-isthmic Cerclage

NCT ID: NCT04722536

Last Updated: 2022-01-11

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-13

Study Completion Date

2021-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Cerclage, Cervical Cervical Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Cervico-isthmic cerclage

Intervention Type PROCEDURE

There is no intervention in this study. It's an observational retrospective study, before/after.

Interventions

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Cervico-isthmic cerclage

There is no intervention in this study. It's an observational retrospective study, before/after.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DEBORAH GAVANIER, MD

Role: PRINCIPAL_INVESTIGATOR

Service de gynécologie-obstétrique - Centre Hospitalier Lyon Sud

Locations

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Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon

Bron, , France

Site Status

Hôpital de la Croix Rousse - Hospices Civils de Lyon

Lyon, , France

Site Status

Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2020-A03187-32

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_1088

Identifier Type: -

Identifier Source: org_study_id

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