Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
NCT ID: NCT02852499
Last Updated: 2019-12-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
1010 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-07-31
Study Completion Date
2021-01-31
Brief Summary
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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.
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
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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.
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.
Conditions
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Healthy Volunteer
Keywords
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environmental epidemiology
cohort
atmospheric pollutant
chemical pollutant
growth, neuro-development, respiratory health
big data
biological samples (RNA, DNA, urines ...)
e-dohad and exposome
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Mothers
Pregnant women.
Urine sampling
Intervention Type
OTHER
Carry a GPS and BET
Intervention Type
OTHER
Carry pollution sensor
Intervention Type
OTHER
Sampling at the maternity
Intervention Type
OTHER
Self-questionnaires
Intervention Type
OTHER
Fathers
Futur fathers.
Urine sampling
Intervention Type
OTHER
Self-questionnaires
Intervention Type
OTHER
Children
Children after childbirth.
Sampling in partum period
Intervention Type
OTHER
Meconium and a strand of hair.
Interventions
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Urine sampling
Intervention Type
OTHER
Carry a GPS and BET
Intervention Type
OTHER
Carry pollution sensor
Intervention Type
OTHER
Sampling at the maternity
Intervention Type
OTHER
Self-questionnaires
Intervention Type
OTHER
Sampling in partum period
Meconium and a strand of hair.
Intervention Type
OTHER
Eligibility Criteria
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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
* \< 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
* no access to the French social security
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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iSABELLE Pin, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Hopital Couple Enfant - Grenoble
La Tronche, , France
Site Status
Countries
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France
References
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DERIVED
Other Identifiers
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38RC13.579
Identifier Type: -
Identifier Source: org_study_id