Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

NCT04549142 | Completed

• 2 other identifiers: IRB-56622R01ES032253
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Air Pollution; Pregnancy

Keywords

immune function

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Pregnant women- high level pollution

Exposed to high levels of pollution (PM2.5)

Other: There is no intervention

Pregnant women- low level pollution

Exposed to low levels of pollution (PM2.5)

Other: There is no intervention

Non-pregnant women-high level pollution

Exposed to high levels of pollution (PM2.5)

Other: There is no intervention

Non-pregnant women-low level pollution

exposed to low levels of pollution (PM2.5)

Other: There is no intervention

Interventions

There is no intervention OTHER

There is no intervention

Non-pregnant women-high level pollution; Non-pregnant women-low level pollution; Pregnant women- high level pollution; Pregnant women- low level pollution

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Duke University: collaborator

Study Sites (1)

Sean N. Parker Center for Allergy & Asthma Research at Stanford University

Palo Alto, California, 94304, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• R. Sharon Chinthrajah, MD

  Stanford, Sean N Parker Center for Allergy and Asthma Center at Stanford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: August 1, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)