Birth Defect Registry in South West Region of France

NCT05231447 | Unknown

• 1 other identifier: CHUBX 2019/36
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Abnormalities

Outcome Measures

Primary Outcomes (1)

• Number of congenital anomalies

  1 year-old

Secondary Outcomes (2)

• Measure of the incidence of congenital anomalies in south west region of France

  1 year-old

• Identification of environmental factors associated with congenital anomalies

  1 year-old

Interventions

Environmental survey OTHER

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.

Eligibility Criteria

• Age: 1 Minute - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Refusal of at least one of the holders of parental authority

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut de Recherche en Santé Publique, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Julie Thomas-Chabaneix, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Marianne Saves, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Julie Thomas-Chabaneix, MD

CONTACT

(0)5 57 65 61 10; julie.thomas@chu-bordeaux.fr

Anne-Cécile Huby

CONTACT

anne-cecile.huby@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

FR (1)