Healthy Volunteer Clinical Trial
Official title:
SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of
Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on
the general population and aims to cover several areas of environmental health research,
including endocrine disruptors and air pollutants.
The main objectives is to quantify the impact of pollution during pregnancy and the first
years of life on three main health outcomes : growth, respiratory health and
neuro-development ; and to better understand the biological mechanism (such as genetic
analysis to study the role of environmental factors on genes expression as well as the role
of genetic factors on health). The objective is to include 500 families.
SEPAGES is a new type of longitudinal couple-child cohort with repeated clinical examinations
during pregnancy and childhood, extensive collection of repeated biological samples from both
parents and the child, use of new technologies to assess exposure to air pollution (GPS,
personal dosimeter etc.) Throughout the study (during pregnancy and the first years of the
child's life), clinical examination and many biological tests (urine, blood, hair) are
performed. Exposure to different environmental factors are made several times during
pregnancy and the first years of the child's life thanks to personal dosimeters, GPS and
accelerometers. During labor and childbirth a number of samples are taken (placenta, tissues,
blood, urines, hair, meconium and breast milk). Finally, during the study a number of
evaluation questionnaires are given to volunteers via a computer platform in order to have a
better understanding of the environment in which they are living.
The SEPAGES cohort follows the rule of the biomedical research. Informed consents are signed
by both the father and the mother during the inclusion visit which takes place in the
hospital. All ethical and data privacy agreements had been obtained : a favorable opinion was
issued by the Comité de Protection des Personnes (CPP) on November 13th, 201 and by the
CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le
domaine de la Santé) on January 09th, 2014. The study was authorised by the Agence Nationale
de Sécurité du Médicament(ANSM), on Decmber 17th, 2013 and by the Comité Nationale de
l'Informatique et des Libertés (CNIL) on June 26th, 2014.
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