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Birth Defect Registry in South West Region of France

Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05231447
Acronym
ATENA
Enrollment
9000
Registered
2022-02-09
Start date
2022-03-01
Completion date
2025-03-01
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Abnormalities

Brief summary

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

Detailed description

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.

Interventions

OTHEREnvironmental 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.

Sponsors

Institut de Recherche en Santé Publique, France
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of congenital anomalies1 year-old

Secondary

MeasureTime frameDescription
Measure of the incidence of congenital anomalies in south west region of France1 year-oldIn number of new cases, expected 2500 cases/year
Identification of environmental factors associated with congenital anomalies1 year-oldEnvironment related variables and drug exposure before (father and mother) and during pregnancy (mother)

Countries

France

Contacts

Primary ContactJulie Thomas-Chabaneix, MD
julie.thomas@chu-bordeaux.fr(0)5 57 65 61 10
Backup ContactAnne-Cécile Huby
anne-cecile.huby@chu-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026