Birth Defect Registry in South West Region of France

Congenital Abnormalities Clinical Trial

— ATENA  

Official title:

Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05231447
• Other study ID #: CHUBX 2019/36
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: Julie Thomas-Chabaneix, MD
• Phone: (0)5 57 65 61 10
• Email: julie.thomas[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Congenital Abnormalities

Intervention

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.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France, Santé publique France

Country where clinical trial is conducted

France, 

Outcome

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