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Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health

SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02852499
Acronym
SEPAGES-1337
Enrollment
1010
Registered
2016-08-02
Start date
2014-07-31
Completion date
2021-01-31
Last updated
2019-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERCarry a GPS and BET
OTHERCarry pollution sensor
OTHERSampling at the maternity
OTHERSampling in partum period

Meconium and a strand of hair.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical exam : biological samplingUp to one hourSampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026