Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health

Healthy Volunteer Clinical Trial

— SEPAGES-1337  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02852499
• Other study ID #: 38RC13.579
• Status: Active, not recruiting
• Start date: July 2014
• Est. completion date: January 2021

Study information

• Verified date: December 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1010
• Est. completion date: January 2021
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Other:
• Urine sampling

• Carry a GPS and BET

• Carry pollution sensor

• Sampling at the maternity

• Self-questionnaires

• Sampling in partum period
Meconium and a strand of hair.

Locations

Country	Name	City	State
France	Hopital Couple Enfant - Grenoble	La Tronche

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical exam : biological sampling	Sampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g	Up to one hour
Primary	Clinical exam : biological sampling	Sampling of : urines, blood in mL	Up to one hour