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Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549142
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
Duke University
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, 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.


Condition or disease Intervention/treatment
Air Pollution Pregnancy Other: There is no intervention

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

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




Primary Outcome Measures :
  1. Difference in immune cell subset identity and function in pregnant vs. non pregnant women exposed to high vs. low pollution over time [ Time Frame: 3 years ]
  2. Identify the epigenetic molecular mechanisms driving immune dysfunction in pregnancy vs. no pregnancy with high vs. low PM2.5 exposure over time [ Time Frame: 3 years ]
  3. Map T cell receptor diversity to immune dysfunction in pregnancy vs non pregnancy with high vs. low PM2.5 exposure over time [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women at 18-25 weeks gestation and non-pregnant women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549142


Locations
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United States, California
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Mountain View, California, United States, 94040
Sponsors and Collaborators
Stanford University
National Institute of Environmental Health Sciences (NIEHS)
Duke University
Investigators
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Principal Investigator: Kari Nadeau, MD, PhD Stanford University
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Responsible Party: Kari Christine Nadeau, MD PhD, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04549142    
Other Study ID Numbers: IRB-56622
R01ES032253 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kari Christine Nadeau, MD PhD, Stanford University:
immune function