EFEMERIS - Assessment of Prescribed Drugs and Associated Risk During Pregnancy
Head :
Damase-Michel Christine, SERVICE DE PHARMACOLOGIE CLINIQUE UNITE « MEDICAMENTS, GROSSESSE ET ALLAITEMENT » UMR 1027, Equipe 6
Lacroix Isabelle, SERVICE DE PHARMACOLOGIE CLINIQUE UNITE « MEDICAMENTS, GROSSESSE ET ALLAITEMENT » UMR 1027
Lacroix Isabelle, SERVICE DE PHARMACOLOGIE CLINIQUE UNITE « MEDICAMENTS, GROSSESSE ET ALLAITEMENT » UMR 1027
Last update : 09/09/2019 | Version : 3 | ID : 60124
| General | |
| Identification | |
| Detailed name | Assessment of Prescribed Drugs and Associated Risk During Pregnancy |
| Sign or acronym | EFEMERIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 05-1140 ; 07/04/2005 |
| General Aspects | |
| Medical area |
Gynecology/ obstetrics Pediatrics |
| Health determinants |
Iatrogenic Medicine |
| Keywords | newborns, neonatal diseases, congenital anomalies, pregnancy, drugs, psychomotor development, pharmacology, abortions |
| Scientific investigator(s) (Contact) | |
| Name of the director | Damase-Michel |
| Surname | Christine |
| Address | 31000 TOULOUSE |
| medrepro@chu-toulouse.fr | |
| Unit | SERVICE DE PHARMACOLOGIE CLINIQUE UNITE « MEDICAMENTS, GROSSESSE ET ALLAITEMENT » UMR 1027, Equipe 6 |
| Organization | UNITE DE PHARMACOEPIDEMIOLOGIE : EVALUATION DE L'EXPOSITION ET DU RISQUE MEDICAMENTEUX |
| Name of the director | Lacroix |
| Surname | Isabelle |
| Address | 31000 TOULOUSE |
| medrepro@chu-toulouse.fr | |
| Unit | SERVICE DE PHARMACOLOGIE CLINIQUE UNITE « MEDICAMENTS, GROSSESSE ET ALLAITEMENT » UMR 1027 |
| Organization | UNITE DE PHARMACOEPIDEMIOLOGIE : EVALUATION DE L'EXPOSITION ET DU RISQUE MEDICAMENTEUX |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | Agence nationale de sécurité du médicament et des produits de santé (ANSM - France) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Toulouse |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services An administrative base or a register |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
To form a cohort of pregnant women in monitoring the registration of medication prescribed and dispensed (during pregnancy) and the outcome of these pregnancies, so as to investigate the potential effects of exposure to drugs on newborns (prematurity, malformations, neonatal pathologies, psychomotor development).
|
| Inclusion criteria | - Women with general state coverage administrated by the primary health insurance fund who gave birth in Haute-Garonne; - women who did not refuse access to information concerning them; - women who have at least one newborn health certificate registered at Mother and Child Protection level or whose pregnancy outcome has been identified by theUniversity Hospital Center . |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Haute-Garonne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 07/2004 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | plus de 135,000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Administrative data |
| Clinical data (detail) |
Medical registration |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by crossing with a medical-administrative database |
| Details on monitoring of participants | Duration 24 months |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Cross-referencing 3 databases - Haute-Garonne CPAM (collection of medication prescribed during pregnancy), - PMI (collection of data for obligatory child health certificates at 8 days, 9 months and 24 months), - University Hospital Center (collection of data concerning pregnancy terminations). |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.efemeris.fr/communications.html |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=EFEMERIS |
| Description | List of publications in Pubmed |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams or by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
