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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05231447
Other study ID # CHUBX 2019/36
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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