Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Air Pollution
• Intervention / Treatment: Other: There is no intervention

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Sean N. Parker Center for Allergy & Asthma Research at Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at 18-25 weeks gestation and non-pregnant women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women- high level pollution; Exposed to high levels of pollution (PM2.5)	Other: There is no intervention; There is no intervention
Pregnant women- low level pollution; Exposed to low levels of pollution (PM2.5)	Other: There is no intervention; There is no intervention
Non-pregnant women-high level pollution; Exposed to high levels of pollution (PM2.5)	Other: There is no intervention; There is no intervention
Non-pregnant women-low level pollution; exposed to low levels of pollution (PM2.5)	Other: There is no intervention; There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Duke University; National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: R. Sharon Chinthrajah, MD, Stanford, Sean N Parker Center for Allergy and Asthma Center at Stanford

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: immune function
• Other Study ID Numbers: IRB-56622; R01ES032253 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No