Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
9000 participants
OBSERVATIONAL
2022-03-01
2025-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LUMIERE on the FETUS
NCT04142606
Epidemiology of Congenital Heart Disease in France
NCT04740177
Prospective Monitoring of Children Born in Haute Vienne From Uterine Life to Adulthood
NCT02674087
Contribution of Multimodal Imaging in Early Coarctation
NCT05203874
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
NCT02767648
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
1 Minute
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut de Recherche en Santé Publique, France
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Bordeaux
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie Thomas-Chabaneix, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Marianne Saves, MD
Role: STUDY_CHAIR
University Hospital, Bordeaux
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bordeaux University Hospital
Pessac, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2019/36
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.