Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health

NCT02852499 | Unknown

• 1 other identifier: 38RC13.579
• Study Type: observational
• Target: 1,010
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

environmental epidemiology; cohort; atmospheric pollutant; chemical pollutant; growth, neuro-development, respiratory health; big data; biological samples (RNA, DNA, urines ...); e-dohad and exposome

Outcome Measures

Primary Outcomes (2)

• Clinical exam : biological sampling

  Sampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g

  Up to one hour

• Clinical exam : biological sampling

  Sampling of : urines, blood in mL

  Up to one hour

Study Arms (3)

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

Interventions

Urine sampling OTHER

Fathers; Mothers

Carry a GPS and BET OTHER

Mothers

Carry pollution sensor OTHER

Mothers

Sampling at the maternity OTHER

Mothers

Self-questionnaires OTHER

Fathers; Mothers

Sampling in partum period OTHER

Meconium and a strand of hair.

Children

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hopital Couple Enfant - Grenoble

La Tronche, 38700, France

Location

Related Publications (38)

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  PMID: 38689737 DERIVED

MeSH Terms

Interventions

DNER protein, human

Study Officials

• iSABELLE Pin, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: January 1, 2021
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

FR (1)