Air PollutionNCT04549142
Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure
An observational study of Air Pollution and Pregnancy, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Air Pollution, Pregnancy
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 12 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women at 18-25 weeks gestation and non-pregnant women
Who may be able to join
- Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit
Who cannot join
- Having smoked more than 50 cigarettes during pregnancy
- A history of autoimmune diseases, HIV or cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Air Pollution, Pregnancy
- Being tested
- There is no intervention
- Keywords
- immune function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women- high level pollution | Exposed to high levels of pollution (PM2.5) Receives: Other: There is no intervention | |
| Pregnant women- low level pollution | Exposed to low levels of pollution (PM2.5) Receives: Other: There is no intervention | |
| Non-pregnant women-high level pollution | Exposed to high levels of pollution (PM2.5) Receives: Other: There is no intervention | |
| Non-pregnant women-low level pollution | exposed to low levels of pollution (PM2.5) Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in immune cell subset identity and function in pregnant vs. non pregnant women exposed to high vs. low pollution over time
Measured: 3 years
Identify the epigenetic molecular mechanisms driving immune dysfunction in pregnancy vs. no pregnancy with high vs. low PM2.5 exposure over time
Measured: 3 years
Map T cell receptor diversity to immune dysfunction in pregnancy vs non pregnancy with high vs. low PM2.5 exposure over time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Aug 2020
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air PollutionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Duke University
- Responsible party
- Principal investigator, R. Sharon Chinthrajah, Stanford University
- Investigators
- R. Sharon Chinthrajah, MD, Principal investigator, Stanford, Sean N Parker Center for Allergy and Asthma Center at Stanford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549142
- Sponsor's protocol ID
- IRB-56622
- Other IDs
- R01ES032253
- Status last verified
- Jun 2023
- First submitted
- 8 Sep 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution
- ClinicalTrials.gov ID
- NCT04549142
- Acronym / sponsor ID
- IRB-56622
- Conditions
- Air Pollution, Pregnancy
- Keywords
- immune function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Duke University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women- high level pollution | – | Other: There is no interventionExposed to high levels of pollution (PM2.5) |
| Pregnant women- low level pollution | – | Other: There is no interventionExposed to low levels of pollution (PM2.5) |
| Non-pregnant women-high level pollution | – | Other: There is no interventionExposed to high levels of pollution (PM2.5) |
| Non-pregnant women-low level pollution | – | Other: There is no interventionexposed to low levels of pollution (PM2.5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women at 18-25 weeks gestation and non-pregnant women
Key inclusion criteria (1 listed)
- Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit
Key exclusion criteria (2 listed)
- Having smoked more than 50 cigarettes during pregnancy
- A history of autoimmune diseases, HIV or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionThere is no intervention | Other | Non-pregnant women-high level pollution, Non-pregnant women-low level pollution, Pregnant women- high level pollution, Pregnant women- low level pollution |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Sharon Chinthrajah, MD principal investigator
Stanford, Sean N Parker Center for Allergy and Asthma Center at Stanford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Air Pollution and Pregnancy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.