Last update : 07/22/2015 | Version : 2 | ID : 5673
| General | |
| Identification | |
| Detailed name | Organochlorine Pesticides: Effects on Pregnancy and Intrauterine and Postnatal Development |
| Sign or acronym | TI MOUN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP (25/05/2011), CCPPRB Guadeloupe (01/10/2004), méthodologie de référence CNIL MR-001 Inserm |
| General Aspects | |
| Medical area |
Gynecology/ obstetrics |
| Health determinants |
Intoxication Pollution |
| Keywords | course, outcome, postnatal neurological development, Health episodes, pregnancy, environment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Cordier |
| Surname | Sylviane |
| Address | 35000 RENNES |
| Phone | + 33 (0)2 23 23 59 29 |
| sylvaine.cordier@inserm.fr | |
| Unit | INSERM U625 UNIVERSITÉ DE RENNES I |
| Organization | INSERM/ CHU |
| Name of the director | Multignier |
| Surname | Luc |
| Address | POINTE À PITRE |
| Phone | + 33 (0)6 90 73 02 82 |
| luc.multigner@inserm.fr | |
| Unit | U625 |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | AFSSET, DGS, INVS, DSDS GUADELOUPE, ANR, PNRPE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | CHU Guadeloupe |
| 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 Inclusion cut-off date: 01/12/2008 |
| Database objective | |
| Main objective | To study the impact on pregnancy (prematurity, delayed intrauterine growth, birth defects) and postnatal neurological development from exposure (prenatal and childhood) to organochlorine pollutants (mainly chlordecone) in Guadeloupe. |
| Inclusion criteria | Pregnant women: living in Guadeloupe, who gave birth in a public sector maternity hospital; Monitored infants: vaginal birth at full term without any extraction manoeuvre or any malformations. |
| Population type | |
| Age |
Newborns (birth to 28 days) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Guadeloupe |
| Detail of the geography area | Guadeloupe |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2005 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1100 femmes enceintes / pregnant women 250 nourrissons / newborns |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Biological data (detail) | Type of samples taken: maternal blood, cord blood, blood from infants at 3 months, breast milk at birth and at 3 months, infant urine. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma DNA |
| Details of biobank content | Serum bank, plasma bank, DNA bank, whole blood |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: direct input Interview: manual input and double entry Clinical Examinations: manual input and double entry Biological analysis: direct input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 7 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | https://hal.archives-ouvertes.fr/search/index/?qa[text][]=timoun+&qa[text][]=&submit_advanced=Rechercher&rows=30 |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=TIMOUN |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Numerous communications to healthcare professionals, healthcare institutions and the public |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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