Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health (SEPAGES-1337)
|ClinicalTrials.gov Identifier: NCT02852499|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2016
Last Update Posted : December 27, 2019
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|
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|
|Actual Enrollment :||1010 participants|
|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|
Other: Urine sampling
Other: Carry a GPS and BET
Other: Carry pollution sensor
Other: Sampling at the maternity
Other: Urine sampling
Children after childbirth.
Other: Sampling in partum period
Meconium and a strand of hair.
- 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
- Clinical exam : biological sampling [ Time Frame: Up to one hour ]Sampling of : urines, blood in mL
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852499
|Hopital Couple Enfant - Grenoble|
|La Tronche, France, 38700|
|Principal Investigator:||iSABELLE Pin, MD||University Hospital, Grenoble|