ITMO public health
Last update : 10/05/2015 | Version : 3 | ID : 230
| General | |
| Identification | |
| Detailed name | Registry of Congenital Malformations in Auvergne (Certified Registry 2012-2015) |
| Sign or acronym | CEMC-Auvergne |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 1387396 |
| General Aspects | |
| Medical area |
Disability/handicap Pediatrics Rare diseases |
| Health determinants |
Addictions Genetic Iatrogenic Lifestyle and behavior Medicine |
| Keywords | prenatal diagnosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Perthus |
| Surname | Isabelle |
| Address | Service de génétique, CHU Estaing, 1 place Lucie Aubrac 63 003 cédex 1 |
| Phone | + 33 (0)4 73 34 19 32 |
| iperthus@chu-clermontferrand.fr | |
| Organization | CEMC-Auvergne |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Regional Health Agency - ARS - French Institute for Public Health Surveillance - InVS -French National Institute of Health and Medical Research - INSERM, private donations. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de Clermont-Ferrand |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Selection of subjects having the required inclusion criteria:- Public and private maternity wards in the Auvergne region- Multidisciplinary center for prenatal diagnosis- Medical and surgical pediatric departments- Cardiology departments- Maxillo-facial surgery- Pediatric urology- Public and private cytogenetics laboratories- Anatomopathology laboratory- Mother and child protection centers (PMIs)- Medical information departments (DIMs) |
| Database objective | |
| Main objective |
The registry's primary objective is to conduct epidemiological surveillance of congenital malformations
in Auvergne, with a role of sounding the alert when any environmental teratogenic agents become evident. With the development of prevention measures - particularly in the field of prenatal diagnosis - this surveillance-alert mission has gradually been extended to include an essential role in evaluating the impact of public health policies with regards to perinatal care on the population. The registry also helps to improve knowledge in the field of malformations by collaborating on studies with specialist clinical departments (particularly genetic and foetal medicine departments) and by being involved in the Multidisciplinary Center for Prenatal Diagnosis in Clermont- Ferrand (the registry's data provides food for thought from obstetricians on the meaning and action to take when certain malformations are observed during prenatal diagnosis). Lastly, the registry's data informs healthcare stakeholders and the public authorities about congenital malformations and chromosomal abnormalities. |
| Inclusion criteria | All malformed children are listed, whether stillborn or a live birth after a pregnancy of at least 22 weeks of amenorrhoea, or in the event of therapeutic abortion due to foetal malformation, regardless of term. For children who are born alive, the malformation diagnosis must have been made before the end of their first year of life (infants may be recorded up to 12 months after their birth). All types of malformation are included, whether these concern isolated or polymalformative syndromes, whether or not identified, with normal or abnormal karyotype. The only types to be excluded are inborn metabolic errors and minor malformations or deformations (snapping hips without real dislocation, deformed feet, small superficial naevi or angiomas less than 4cm2, inguinal hernia, umbilical hernia not requiring surgery, isolated persistent ductus arteriosus in premature infants weighing less than 2.5kg, hypertrophic pyloric stenosis, single umbilical artery, uni- or bilateral ectopic testis). |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Auvergne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1983 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 10 145 patients (1983-2011) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Paraclinical data (detail) | MRI, scan, radiographies, ultrasounds (prenatal, foetal echocardiography, in post-natal stages: urinary tracts, cardio, etc.). |
| Biological data (detail) | cytogenetic examinations, maternal serum markers. |
| Administrative data (detail) | Identification data. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | primarily active +/- passive. |
| Classifications used | ICD 10, ATC. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Vital status:The vital status is reported systematically when each case is being registered. The following are distinguished: - children who are alive when the report is made to the registry - therapeutic abortions before 22 weeks of amenorrhoea- therapeutic abortions after 22 weeks of amenorrhoea- fetal deaths in utero- infants who have died (in the first 8 days of life, between 8 and 28 days or after 28 days) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-CEMC |
| Description | Liste des publications dans Pubmed |
| Link to the document | http://tinyurl.com/HAL-CEMC |
| Description | Liste des publications dans HAL |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | By request to the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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