REMACA - Registry of Congenital Malformations in Alsace (Certified Regisrtry)
Head :
Timbolschi Danaluiza
Last update : 08/04/2015 | Version : 2 | ID : 62
| General | |
| Identification | |
| Detailed name | Registry of Congenital Malformations in Alsace (Certified Regisrtry) |
| Sign or acronym | REMACA |
| General Aspects | |
| Medical area |
Rare diseases |
| Health determinants |
Addictions Genetic Occupation Social and psychosocial factors |
| Keywords | prenatal diagnosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Timbolschi |
| Surname | Danaluiza |
| danaluiza.timbolschi@chru-strasbourg.fr | |
| Organization | CHRU Strasbourg |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | French Institute for Public Health Surveillance - InVS, French National Institute of Health and Medical Research) - INSERM CREGEMES. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université de Strasbourg, Faculté de médecine |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Method for selecting subjects meeting required inclusion criteria. |
| Database objective | |
| Main objective |
From an epidemiological standpoint:
1) Determination of frequency (in terms of prevalence) and distribution of congenital malformation; 2) Identification of the risk factors of malformations (discomfort, environment, medications and toxic) 3) Determination of malformation ""clusters"" for decision aids in the event of a significant increase in the prevalence of a malformation type (monitoring-alert); 4) Making data available for epidemiological studies From a public health standpoint 1) Assessment of the impact of health policies in the field of perinatal medicine and the impact of regional obstetric practices; 2) Measuring the effectiveness of the prevention and establishment of support to inform healthcare professionals, especially in the field of teratology; 3) Assessment of healthcare requirements in perinatal medicine (birthing methods and locations); From a clinical standpoint: 1) Locating new malformation associations and even the identification of new symptoms; 2) Determination of modes of genetic disorder transmission; 3) Establishment of interactions among various active partners in prevention, socio-educational care in the region concerned. |
| Inclusion criteria |
Reported cases of malformations visible at the clinical and visceral examination, as well as identified or non-identified malformation syndromes, including those linked to chromosomal defects until two years old..
Recorded cases in the both Alsace départements and where parents are only residing both Alsace départements. |
| 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 |
Alsace Champagne-Ardenne Lorraine |
| Detail of the geography area | Two départements in the Alsace region: Bas-Rhin and Haut-Rhin. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | About 700 cases per year since 2005. About 450 cases per year since 2005. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Radiographies, ultrasounds, scan, MRI, ophthalmologic and ENT assessment. |
| Biological data (detail) | Cytogenetic, molecular biology. |
| Administrative data (detail) | Identification data: child (last name, first name, address, date of birth, place of birth, date of death, cause of death); mother (date of birth, place of birth); father (date of birth, place of birth); Socio-demographic data: profession of the mother; profession of the father; consanguinity. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation |
| Procedures | |
| Data collection method | Active collection from all of the public and private maternity wards in Alsace, from all of Paediatric, Infant Surgery, Genetics, Paediatric Cardiology, Neurosurgery and Ophthalmology departments, from the Multidisciplinary Centre for Prenatal Diagnosis, from cytogenics and foetopathology laboratories. |
| Classifications used | CIM10 for malformations and diseases, ATC code for medication. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Verification of the diagnosis, Updating of vital status for reported cases on an average of 6 months to 1 year, as well as the cause of death. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Health certificates for the 8th day, 9th month. |
| Promotion and access | |
| Promotion | |
| Other information | The registry is no longer active |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Global data: EUROCAT site.
Individual data: on request. |
| Access to aggregated data |
Free access |
| Access to individual data |
Access on specific project only |
