REMERA - Rhône Alpes birth defects registry
Head :
Amar Emmanuelle, REMERA9 Quai Jean Moulin690001 LYON
Last update : 05/11/2015 | Version : 2 | ID : 69
| General | |
| Identification | |
| Detailed name | Rhône Alpes birth defects registry |
| Sign or acronym | REMERA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°910397 |
| General Aspects | |
| Medical area |
Disability/handicap Gynecology/ obstetrics |
| Health determinants |
Addictions Genetic Iatrogenic Intoxication Lifestyle and behavior Medicine Nutrition Occupation Pollution Social and psychosocial factors |
| Keywords | prevalence of congenital malformations, reprotoxic risk factors, antenatal screening, eugenic abortions, perinatality, database on malformations, epidemiology, follow-up, alert, teratogens, genetics |
| Scientific investigator(s) (Contact) | |
| Name of the director | Amar |
| Surname | Emmanuelle |
| Address |
7 rue Ste Catherine 69 001 LYON |
| Phone | + 33 (0)4 78 58 34 84 |
| emmanuelle.amar@remera.fr | |
| Unit | REMERA9 Quai Jean Moulin690001 LYON |
| Organization | REMERA et CHU DE |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | InVS, Conseil Régional Rhône Alpes, Inserm, Afssaps, Registre qualifié de 2009 à 2011 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Registre des Malformations en Rhône Alpes |
| Organisation status |
Both |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Database objective | |
| Main objective |
Objectives in terms of public health:
1) Evaluation of the importance of the change in malformations (incidence, factors, appearance of a new malformation or of a new malformation symptom, space-time variations of these incidences) 2) Evaluation of the actions in public health: measure the impact of the actions implemented, especially perinatal screening and also the primary prevention initiatives on the prevalence of malformations and propose orientations for the development of health programs. 3) Alert in the case where a link with a teratogen, whether or not known, is suspected In terms of research: 1) Highlight the factors of risk of malformation 2) Study their interactions with susceptibilities of a genetic nature |
| Inclusion criteria |
The following are included in the registry:
Congenital malformations diagnosed antenatally or postnatally until the end of the first year of life. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Département of Rhône, Isère, Savoie, and Loire |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1973 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 61 000 (in 2012) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Phone interview |
| Paraclinical data (detail) | Height, weight, BP of mother ; height, weight, head circumference, crown-rump length of the child/fetus |
| Biological data (detail) | triple test, karyotype, glycemia |
| Administrative data (detail) | Identification data (Name, first name, birthday, location, sex) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Active collection: survey takers go to the departments and record in their databases all of the information contained in the medical dossiers concerning congenital malformations and their determinants |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
An annual activity report
Access to the data (depersonalized) is possible, on request |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
