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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Healthy Volunteer

Treatments: Other: Sampling in partum period; Other: Urine sampling; Other: Self-questionnaires; Other: Sampling at the maternity; Other: Carry a GPS and BET; Other: Carry pollution sensor

Study type: Observational

Funder types: Other

Identifiers

NCT02852499

38RC13.579

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,010 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,010 participants in 3 patient groups

Mothers

Description:

Pregnant women.

Treatment:

Other: Sampling at the maternity

Other: Carry pollution sensor

Other: Carry a GPS and BET

Other: Urine sampling

Other: Self-questionnaires

Fathers

Description:

Futur fathers.

Treatment:

Other: Urine sampling

Other: Self-questionnaires

Children

Description:

Children after childbirth.

Treatment:

Other: Sampling in partum period