Clinical trial NCT05231447: Birth Defect Registry in South West Region of France
Official title: Registry of Congenital Anomalies in Nouvelle-Aquitaine, France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Abnormalities
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Publique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-02-09
Enrollment: 9000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases are defined as all fetuses/children under 1 year of age with a congenital or chromosomal abnormality as defined by the european surveillance of congenital anomalies (EUROCAT) network.

The excluded minor anomalies are established by EUROCAT. The register covers the geographical area of the Nouvelle Aquitaine region in France.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of congenital anomalies
timeFrame: 1 year-old
Secondary outcomes:
measure: Measure of the incidence of congenital anomalies in south west region of France
timeFrame: 1 year-old
measure: Identification of environmental factors associated with congenital anomalies
timeFrame: 1 year-old
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Julie Thomas-Chabaneix, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Marianne Saves, MD
role: STUDY_CHAIR
References: