Birth Defect Registry in South West Region of France

NCT ID: NCT05231447

Last Updated: 2022-03-09

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

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-03-01

Brief Summary

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Regional population-based registry for the epidemiological surveillance of congenital anomalies

Detailed Description

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By systematically collecting data on congenital anomalies, the registry aims to :

* provide essential epidemiological information on congenital anomalies in South West of France
* Promote etiological research concerning congenital anomalies, particularly with regard to environmental risk factors (systematic questionnaire) and other teratogenic agents (drugs)
* act as an information and resource center for the population, health professionals and managers regarding clusters or exposures or risk factors of concern.
* evaluate the effectiveness of primary prevention
* assess the impact of developments in prenatal screening
* study the fate of children with congenital anomalies, particularly in terms of neurodevelopment, through the creation of cohorts.

Conditions

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Congenital Abnormalities

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Environmental survey

Exposure to environmental factors, drugs or individual toxicity during the periconceptional period and at the beginning of the pregnancy will be investigated by means of a questionnaire administered to the parents. This questionnaire, drawn up by the "Aquitaine Reproduction Enfance Maternité et Impact Santé-environnement" (ARTEMIS) centre and completed by both members of the couple, will constitute an initial assessment that will make it possible to collect environmental exposures for the parents of cases identified by the register.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Children or Fetuses:

* Born alive or stillborn or fetal death in utero or medical termination of pregnancy
* Of mothers domiciled in New Aquitaine at the time of delivery
* And presenting a congenital or chromosomal anomaly defined according to the EUROCAT network, diagnosed antenatally or postnatally up to one year of life.
* Of which the non-opposition of both holders or of the only holder of parental authority has been given
* Whose mother and/or father is affiliated or beneficiary of a social security system.

Exclusion Criteria

* Refusal of at least one of the holders of parental authority
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherche en Santé Publique, France

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Thomas-Chabaneix, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Marianne Saves, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Bordeaux University Hospital

Pessac, , France

Site Status

Countries

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France

Central Contacts

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Julie Thomas-Chabaneix, MD

Role: CONTACT

(0)5 57 65 61 10 ext. +33

Anne-Cécile Huby

Role: CONTACT

Facility Contacts

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Julie Thomas-Chabaneix, MD

Role: primary

(0)5 57 65 61 10 ext. +33

Anne-Cécile Huby

Role: backup

Other Identifiers

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CHUBX 2019/36

Identifier Type: -

Identifier Source: org_study_id

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