Birth Defect Registry in South West Region of France

Not yet recruiting

• Conditions: Congenital Abnormalities

• Registration Number: NCT05231447
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Status Verified: 2022-02
• Study First Posted: 2022-02-09
• Last Update Submitted: 2022-02-21
• Study Start: 2022-03-01
• Last Update Posted: 2022-03-09
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of congenital anomalies	1 year-old

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France