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Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

NCT ID: NCT04549142

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Air Pollution Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women- high level pollution

Exposed to high levels of pollution (PM2.5)

There is no intervention

Intervention Type OTHER

There is no intervention

Pregnant women- low level pollution

Exposed to low levels of pollution (PM2.5)

There is no intervention

Intervention Type OTHER

There is no intervention

Non-pregnant women-high level pollution

Exposed to high levels of pollution (PM2.5)

There is no intervention

Intervention Type OTHER

There is no intervention

Non-pregnant women-low level pollution

exposed to low levels of pollution (PM2.5)

There is no intervention

Intervention Type OTHER

There is no intervention

Interventions

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There is no intervention

There is no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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R. Sharon Chinthrajah

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R. Sharon Chinthrajah, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01ES032253

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-56622

Identifier Type: -

Identifier Source: org_study_id

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