Clinical trial NCT02852499: Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
Official title: SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Volunteer
Keywords: environmental epidemiology
cohort
atmospheric pollutant
chemical pollutant
growth, neuro-development, respiratory health
big data
biological samples (RNA, DNA, urines ...)
e-dohad and exposome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-02
Enrollment: 1010
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women before 19 getsationel week, older than 18 years old Father of the children Children at birth

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* \< 19 gestational weeks
* \> 18 years old
* living in the area of Grenoble
* planning to give birth in one of the four maternities located in Grenoble

Exclusion Criteria:

* not speaking French
* no access to the French social security

Primary outcomes:
measure: Clinical exam : biological sampling
timeFrame: Up to one hour
measure: Clinical exam : biological sampling
timeFrame: Up to one hour
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Hopital Couple Enfant - Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: iSABELLE Pin, MD
role: PRINCIPAL_INVESTIGATOR
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