Congenital Abnormalities Clinical Trial
— ATENAOfficial title:
Registry of Congenital Anomalies in Nouvelle-Aquitaine, France
Regional population-based registry for the epidemiological surveillance of congenital anomalies
Status | Not yet recruiting |
Enrollment | 9000 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Year |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Bordeaux University Hospital | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Institut National de la Santé Et de la Recherche Médicale, France, Santé publique France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of congenital anomalies | 1 year-old | ||
Secondary | 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 | |
Secondary | 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 |
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