Last update : 10/19/2017 | Version : 1 | ID : 8535
General | |
Identification | |
Detailed name | Monitoring of Exposure to Air Pollution during Pregnancy and Effect on Health |
Sign or acronym | SEPAGES, Sépages |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL agreement no. 912098, favourable opinion received on 04/10/2012 |
General Aspects | |
Medical area |
Endocrinology and metabolism Gynecology/ obstetrics Neurology Pediatrics Pneumology Study of allergies |
Pathology (details) | Respiratory diseases |
Health determinants |
Climate Genetic Geography Lifestyle and behavior Nutrition Pollution Others (specify) |
Others (details) | Endocrine disruptors |
Keywords | atmospheric pollution, respiratory health, foetal growth, epigenetics, phenols, bisphenol A, Exposure, foetus, newborn, pregnancy, environment, child, phthalates, BPA |
Scientific investigator(s) (Contact) | |
Name of the director | Slama |
Surname | Rémy |
Address | Allée des Alpes, F-38700 La Tronche, France |
Phone | +33 (0)4 76 54 94 02 |
remy.slama@univ-grenoble-alpes.fr | |
Unit | IAB, Inserm, CNRS and University Grenoble-Alpes joint research center |
Organization | Inserm - Institut national de la santé et de la recherche médicale |
Name of the director | Pin |
Surname | Isabelle |
Address | Allée des Alpes, F-38700 La Tronche, France |
ipin@chu-grenoble.fr | |
Unit | IAB, Inserm, CNRS and University Grenoble-Alpes joint research center |
Organization | Inserm et CHU de Grenoble |
Collaborations | |
Participation in projects, networks and consortia |
Yes |
Details | European Helix project |
Others | HBM4EU |
Funding | |
Funding status |
Public |
Details | - European Research Council - ANR |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Inserm - Institut national de la santé et de la recherche médicale |
Organisation status |
Public |
Presence of scientific or steering committees |
Yes |
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. |
Couples-children cohort.
Participation on a voluntary basis, inclusion is in the first trimester of pregnancy (or early in the second trimester). |
Database objective | |
Main objective |
The main objectives are:
- to better characterise environmental exposure experienced during pregnancy and its impact on the health of a pregnant woman, foetus, newborn and child by paying particular attention to foetal growth and respiratory health - to study the biological mechanisms by which environmental factors might influence health, particularly epigenetic mechanisms. The targeted environmental factors are: - air pollutants (fine particles, nitrogen oxide, benzene and BTEX series) - endocrine disruptors, including phenols and phthalates - at term, exposome |
Inclusion criteria |
- be aged over 18 years
- be covered by a social security system (French or foreign) - be pregnant by 19 weeks and 6 days maximum - have a single pregnancy (and not twins) - reside in Isère, in an area not more than one hour from Grenoble - not be considering moving away from the inclusion area within the next two years |
Population type | |
Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
Population covered |
General population |
Pathology | |
Gender |
Male Woman |
Geography area |
Local |
French regions covered by the database |
Auvergne Rhône-Alpes |
Detail of the geography area | Grenoble urban area (4 maternity clinics of Grenoble: Clinique Belledonne, Clinique des Cèdres, Clinique du Groupe Hospitalier Mutualiste or at the Hôpital Couple Enfant) |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 03/2014 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 500 families (mother, father, child) (estimation) |
Data | |
Database activity |
Current data collection |
Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
Clinical data (detail) |
Medical registration |
Details of collected clinical data | Clinical data on the growth, respiratory and cardiovascular health of the parents in the first stage and then that of their child from birth. |
Declarative data (detail) |
Internet self-questionnaire |
Details of collected declarative data | Questionnaires, (self)-administered via a computer platform, to better understand the environment in which the volunteers live (Environmental exposure in the workplace, the presence of domestic animals at home, tobacco consumption, dietary habits, etc.). |
Paraclinical data (detail) | Individual measurement tools (GPS, accelerometers, atmospheric pollution dosimeters). |
Biological data (detail) | During pregnancy: urine, blood and hair specimens. At the time of delivery: placenta, tissue, blood, urine, hair, meconium and milk specimens. |
Presence of a biobank |
Yes |
Contents of biobank |
DNAc/RNAm |
Details of biobank content | The RNA and DNA are stored in numbered tubes with no nominal information. |
Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception Others |
Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
Other (detail) | Exposure to atmospheric pollution; exposure to endocrine disruptors (phenols, phthalates) |
Procedures | |
Participant monitoring |
Yes |
Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by convocation of the participant |
Details on monitoring of participants | The monitoring of the pregnancy takes place until the birth of the child then the monitoring of the child continues until at least 3 years of age. |
Followed pathology | J00-J06 - Acute upper respiratory infections |
J20-J22 - Other acute lower respiratory infections | |
J30-J39 - Other diseases of upper respiratory tract | |
J40-J47 - Chronic lower respiratory diseases | |
J45 - Asthma | |
E65-E68 - Obesity and other hyperalimentation | |
F54 - Psychological and behavioural factors associated with disorders or diseases classified elsewhere | |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Dedicated website | http://sepages.inserm.fr/fr/accueil/ |
Presence of document that lists variables and coding procedures |
No |
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 |
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