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

December 26, 2019 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • Hopital Couple Enfant - Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to one hour
Clinical exam : biological sampling
Time Frame: Up to one hour
Sampling of : urines, blood in mL
Up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: iSABELLE Pin, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC13.579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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