PreeclampsiaNCT00468663
Ambient Air Pollution, Preeclampsia, and Preterm Delivery
An observational study of Preeclampsia and Preterm Delivery, run by National Institute of Environmental Health Sciences (NIEHS).
Trial summary
An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preeclampsia, Preterm Delivery
- How many people
- 4,200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to May 2009
- 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
- Adult, Older adult
Who may be able to join
- English speaking
- enrolled in parent study
- pregnant at <20 weeks gestation and attending prenatal care clinics affiliated with Swedish Medical Center and Tacoma General Hospital
Who cannot join
- -
About this study
An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery.
Read the detailed description
We will design models that use local traffic, weather, and population characteristics to predict monthly ambient concentrations of fine particulate matter (PM2.5) and carbon monoxide (CO). These models will be used to estimate study participants' PM2.5 and CO exposures during and before pregnancy. We will test whether these air pollutant exposures are associated with subsequent risk of preeclampsia and preterm delivery. Additionally, we will test biological markers of maternal lipid peroxidation (thiobarbituric acid reactive substances) and inflammation (high sensitivity C-reactive protein) in maternal blood samples drawn during early pregnancy. We will also examine carboxyhemoglobin measured in early-pregnancy maternal blood samples as a marker of CO exposure.
- Conditions
- Preeclampsia, Preterm Delivery
- Keywords
- preeclampsia, preterm delivery, lipid peroxidation, inflammation
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startJul 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Carole Rudra, Ph.D, MPH, Principal investigator, Swedish Medical Center, First HillMichelle A Williams, Sc.D, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468663
- Sponsor's protocol ID
- 14716-CP-001
- Status last verified
- Apr 2015
- First submitted
- 2 May 2007
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambient Air Pollution, Preeclampsia, and Preterm Delivery
- ClinicalTrials.gov ID
- NCT00468663
- Acronym / sponsor ID
- 14716-CP-001
- Conditions
- Preeclampsia, Preterm Delivery
- Keywords
- preeclampsia, preterm delivery, lipid peroxidation, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Jul 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 May 2007 (estimated)
- 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.
An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery.
Detailed description
We will design models that use local traffic, weather, and population characteristics to predict monthly ambient concentrations of fine particulate matter (PM2.5) and carbon monoxide (CO). These models will be used to estimate study participants' PM2.5 and CO exposures during and before pregnancy. We will test whether these air pollutant exposures are associated with subsequent risk of preeclampsia and preterm delivery. Additionally, we will test biological markers of maternal lipid peroxidation (thiobarbituric acid reactive substances) and inflammation (high sensitivity C-reactive protein) in maternal blood samples drawn during early pregnancy. We will also examine carboxyhemoglobin measured in early-pregnancy maternal blood samples as a marker of CO exposure.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- enrolled in parent study
- pregnant at <20 weeks gestation and attending prenatal care clinics affiliated with Swedish Medical Center and Tacoma General Hospital
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Apr 2015.
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Preeclampsia
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.
Carole Rudra, Ph.D, MPH principal investigator
Swedish Medical Center, First Hill
Michelle A Williams, Sc.D principal investigator
Swedish Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Preterm Delivery, run by National Institute of Environmental Health Sciences (NIEHS).
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 3 inclusion and 1 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 14 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.