Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

Completed

• Conditions: Pregnancy; Air Pollution
• Interventions: Other: There is no intervention

• Registration Number: NCT04549142
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Status Verified: 2023-06
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit

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Exclusion Criteria

• Having smoked more than 50 cigarettes during pregnancy
• A history of autoimmune diseases, HIV or cancer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women- low level pollution	There is no intervention	Exposed to low levels of pollution (PM2.5)
Non-pregnant women-low level pollution	There is no intervention	exposed to low levels of pollution (PM2.5)
Pregnant women- high level pollution	There is no intervention	Exposed to high levels of pollution (PM2.5)
Non-pregnant women-high level pollution	There is no intervention	Exposed to high levels of pollution (PM2.5)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sean N. Parker Center for Allergy & Asthma Research at Stanford University; 🇺🇸 Palo Alto, California, United States