- Registry of Congenital Malformations in Brittany (qualified registry 2013-2015)
Head :
Rouget Florence , U1085 Institut de recherche, santé, environnement et travail.
Last update : 11/03/2015 | Version : 2 | ID : 7517
| General | |
| Identification | |
| Detailed name | Registry of Congenital Malformations in Brittany (qualified registry 2013-2015) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°910138 du 11/8 /2010 ; CCTIRS n° 10.145 du 11/3/2010 |
| General Aspects | |
| Medical area |
Disability/handicap |
| Health determinants |
Geography Lifestyle and behavior |
| Keywords | heart defects, diaphragmatic hernia, hypospadia, Spina bifida |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rouget |
| Surname | Florence |
| Address | 263 avenue du Général Leclerc, campus de Beaulieu - BAT 13 - 35042 RENNES |
| Phone | +33 (0)2 23 23 61 69 |
| florence.rouget@inserm.fr | |
| Unit | U1085 Institut de recherche, santé, environnement et travail. |
| Organization | CHU de |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | - Institut de veille sanitaire - InVS- Agence régionale de santé - ARS- Conseil général |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de Rennes |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Cases referred by practitioners and researcher completeness checks. |
| Database objective | |
| Main objective | To carry out a health watch, monitor prevalency according to time and space and identify tetrogenic factors. To assess medical treatment requirements. To study environmental factors and begin a geospatial analyses for certain malformations in connection with surrounding activities. |
| Inclusion criteria | - Live births or foetal deaths with gestational age at ≥22 weeks and pregnancy terminations for medical reasons - born on or after 1st September 2010 - with congenital anomaly (EUROCAT criteria) diagnosed during the first year of life - mother living in Brittany. |
| 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 |
Bretagne |
| Detail of the geography area | Brittany: Ille et Vilaine and Côtes d'Armor (106 registered centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2010 |
| Date of last collection (YYYY or MM/YYYY) | 10/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 700 /an /year |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | --- |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.cclinouest.com/JOSE/Page_2012/Rouget_registre_phrc_JOSE3.pdf |
| Link to the document | http://tinyurl.com/HAL-RMCB |
| Description | Liste des publications dans HAL |
| Link to the document | http://tinyurl.com/PUBMED-RMCB |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
