ITMO public health
Last update : 09/05/2017 | Version : 3 | ID : 73143
| General | |
| Identification | |
| Detailed name | Assessment of the Impact of Exposure to Occupational and Environmental Chemicals During Pregnancy on Pregnancy Outcome and Child Development |
| Sign or acronym | PELAGIE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°902076 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Gynecology/ obstetrics Pediatrics Psychology and psychiatry |
| Study in connection with Covid-19 |
No |
| Health determinants |
Climate Geography Intoxication Lifestyle and behavior Occupation Pollution |
| Keywords | Solvents, Persistent Organic Polluants, Water Disinfection by-products; Pregnancy outcomes, child development. Main cohort topics: Health and environment., Pesticides |
| Scientific investigator(s) (Contact) | |
| Name of the director | Chevrier |
| Surname | Cécile |
| Phone | +33 (0)2 23 23 61 26 |
| cecile.chevrier@inserm.fr | |
| Unit | IRSET U1085 INSERM Université Rennes 1 |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Europeans projects: Hi-WATE, ENRIECO, CHICOS,... |
| Funding | |
| Funding status |
Public |
| Details | InVS, direction des relations du travail (Ministère des affaires sociales), ANR, ANSES-AFFSET, Fondation de France, DRASS Bretagne. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| 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 |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Other bodies active in creating this cohort: CHU RENNES, maternity hospitals, obstetricians, paediatrians, biological laboratories in Lille and Brest. Pregnant women inclusion cut-off date: 01/12/2005 |
| Database objective | |
| Main objective |
General objective: to assess the impact of early-life exposure to occupational and environmental chemicals on pregnancy outcome and child development, including exposure to solvents, pesticides, persistants pollutants and chlorinated derivatives in water.
Secondary objectives: - to identify environmental sources and individual determinants (socio-demographic characteristics, lifestyle, genetic susceptibility) of exposure to pollutants measured by biomarkers - to investigate the respective roles of prenatal exposure and exposure during childhood |
| Inclusion criteria | Women in their first trimester of pregnancy (less than 19 weeks amenorrhoea) living in one of the "départements" participating in the study. |
| Population type | |
| Age |
Newborns (birth to 28 days) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Bretagne |
| Detail of the geography area | Multicentric cohort throughout France (40 centres): ILLE ET VILAINE, COTES D'ARMOR, FINISTERE |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 03/2002 |
| Date of last collection (YYYY or MM/YYYY) | on-going |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 3421 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | At birth; neurospychological exaination at 6 years old; growth and pubertal developement at 12 years old |
| Declarative data (detail) |
Paper self-questionnaire |
| Biological data (detail) | Type of samples taken: umbilical cord blood, urine (prenatal, childhood), placenta fragment, hair (maternal at birth, childhood), saliva (mother, child), blood (child) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Cord blood Fluids (saliva, urine, amniotic fluid, …) Tissues DNA |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: manual input with double data entry Clinical examinations: manual input with double data entry |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | SISE-WATER |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/PELAGIE |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Publications-Pubmed-PELAGIE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Data may be used by academic teams
To be decided if data may be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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