Birth Defect Registry in South West Region of France

Study Overview
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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.

Official Title
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Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

Conditions
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Congenital Abnormalities

Intervention / Treatment
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* Other: Environmental survey


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of congenital anomalies |  | 1 year-old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the incidence of congenital anomalies in south west region of France | In number of new cases, expected 2500 cases/year | 1 year-old | 
| Identification of environmental factors associated with congenital anomalies | Environment related variables and drug exposure before (father and mother) and during pregnancy (mother) | 1 year-old |