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NCT04549142 Clinical Trial

Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

Pregnancy Clinical Trial

Official title:
Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04549142
Other study ID # IRB-56622
Secondary ID R01ES032253
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date June 12, 2023

Study information
Verified date June 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to study the effects of air pollution toxicants on pregnant mothers' immune health during and after pregnancy. Using already collected samples, this study proposes to evaluate changes in immune function in response to air pollution with the use of innovative technologies, to identify the drivers of immune dysfunction and potential modifiable factors, and to determine how these immune findings are associated with pollution exposure and outcomes of disease.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 12, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit Exclusion Criteria: - Having smoked more than 50 cigarettes during pregnancy - A history of autoimmune diseases, HIV or cancer

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• There is no intervention
There is no intervention

Locations
Country Name City State
United States Sean N. Parker Center for Allergy & Asthma Research at Stanford University Palo Alto California

Sponsors (3)
Lead Sponsor Collaborator
Stanford University Duke University, National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in immune cell subset identity and function in pregnant vs. non pregnant women exposed to high vs. low pollution over time 3 years
Primary Identify the epigenetic molecular mechanisms driving immune dysfunction in pregnancy vs. no pregnancy with high vs. low PM2.5 exposure over time 3 years
Primary Map T cell receptor diversity to immune dysfunction in pregnancy vs non pregnancy with high vs. low PM2.5 exposure over time 3 years
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