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Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health (SEPAGES-1337)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852499
Recruitment Status : Active, not recruiting
First Posted : August 2, 2016
Last Update Posted : December 27, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment
Healthy Volunteer Other: Urine sampling Other: Carry a GPS and BET Other: Carry pollution sensor Other: Sampling at the maternity Other: Self-questionnaires Other: Sampling in partum period

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.

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Study Type : Observational
Actual Enrollment : 1010 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
Study Start Date : July 2014
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : January 2021

Group/Cohort Intervention/treatment
Mothers
Pregnant women.
Other: Urine sampling
Other: Carry a GPS and BET
Other: Carry pollution sensor
Other: Sampling at the maternity
Other: Self-questionnaires
Fathers
Futur fathers.
Other: Urine sampling
Other: Self-questionnaires
Children
Children after childbirth.
Other: Sampling in partum period
Meconium and a strand of hair.




Primary Outcome Measures :
  1. Clinical exam : biological sampling [ Time Frame: Up to one hour ]
    Sampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g

  2. Clinical exam : biological sampling [ Time Frame: Up to one hour ]
    Sampling of : urines, blood in mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852499


Locations
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France
Hopital Couple Enfant - Grenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: iSABELLE Pin, MD University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02852499    
Other Study ID Numbers: 38RC13.579
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Keywords provided by University Hospital, Grenoble:
environmental epidemiology
cohort
atmospheric pollutant
chemical pollutant
growth, neuro-development, respiratory health
big data
biological samples (RNA, DNA, urines ...)
e-dohad and exposome