PELAGIE - Assessment of the Impact of Exposure to Occupational and Environmental Chemicals During Pregnancy on Pregnancy Outcome and Child Development ARCHIVE

Head :
Chevrier Cécile, IRSET U1085 INSERM Université Rennes 1

Last update : 09/05/2017 | Version : 3 | ID : 73143

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
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
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
Scientific investigator(s) (Contact)
Name of the director Chevrier
Surname Cécile
Phone +33 (0)2 23 23 61 26
Email cecile.chevrier@inserm.fr
Unit IRSET U1085 INSERM Université Rennes 1
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)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Population covered General population
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 Data collection completed
Type of data collected Clinical data
Declarative 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
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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