跳至主要内容
临床试验/NCT02852499
NCT02852499Unknown不适用

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

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,010
试验地点
1
主要终点
Clinical exam : biological sampling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •not speaking French
  • •no access to the French social security

结局指标

主要结局

Clinical exam : biological sampling

时间窗: Up to one hour

Sampling of : urines, blood in mL

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验