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Status unknownNCT05231447ATENAUpdated Mar 9, 2022

Birth Defect Registry in South West Region of France

An observational study in Congenital Abnormalities, sponsored by University Hospital, Bordeaux. Status unknown at 1 site in France. Open to participants aged 1 Minute to 1 Year. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by University Hospital, Bordeaux · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9,000
Ages
1 Minute to 1 Year
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Congenital Abnormalities
03

In context

Congenital Abnormalities

993 studies on the registry are indexed under Congenital Abnormalities; 174 are open to participants now.

This study's planned enrollment of 9,000 is above the median of 153 across 449 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Browse University Hospital, Bordeaux studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refusal of at least one of the holders of parental authority
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • OtherEnvironmental 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.

06

What researchers measure

Primary outcomes

  1. Number of congenital anomalies

    Time frame: 1 year-old

Secondary outcomes

  1. Measure of the incidence of congenital anomalies in south west region of France

    In number of new cases, expected 2500 cases/year

    Time frame: 1 year-old

  2. Identification of environmental factors associated with congenital anomalies

    Environment related variables and drug exposure before (father and mother) and during pregnancy (mother)

    Time frame: 1 year-old

07

Study locations

1 site
  • Bordeaux University Hospital
    Pessac, 33604, France
    • Julie Thomas-Chabaneix, MD · Contact · julie.thomas@chu-bordeaux.fr · (0)5 57 65 61 10
    • Anne-Cécile Huby · Contact · anne-cecile.huby@chu-bordeaux.fr
    • Caroline Rooryck-Thambo, MD PhD · Sub investigator
    • Marianne Saves, MD PhD · Sub investigator
    • Fleur Delva, MD PhD · Sub investigator
    • Romain Griffier, MD · Sub investigator
    • Florence Francis, MD · Sub investigator
    • Julie Thomas-Chabaneix, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2022; primary completion for Mar 2025, 36 months later.

Of 144 non-industry observational studies under Congenital Abnormalities, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 24. This study's planned 36 months is below that.

Counting every sponsor, half of 162 studies reached it within 52 months; a quarter within 28 and three quarters within 186.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2022
First posted
Feb 9, 2022
StartEst.
Mar 1, 2022
Primary completionEst.
Mar 1, 2025
CompletionEst.
Mar 1, 2025
Last update
Mar 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05231447
Lead sponsor
University Hospital, Bordeaux
Collaborators
Institut de Recherche en Santé Publique, France, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Feb 9, 2022
Start date
Mar 1, 2022 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Mar 9, 2022

Study contacts

Julie Thomas-Chabaneix, MD
Contact
julie.thomas@chu-bordeaux.fr
(0)5 57 65 61 10 ext. +33
Anne-Cécile Huby
Contact
anne-cecile.huby@chu-bordeaux.fr
Julie Thomas-Chabaneix, MD
principal investigator · University Hospital, Bordeaux
Marianne Saves, MD
study chair · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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