Ambient Air Pollution, Preeclampsia, and Preterm Delivery

April 13, 2015 updated by: National Institute of Environmental Health Sciences (NIEHS)
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Carole Rudra, Ph.D, MPH, Swedish Medical Center, First Hill
  • Principal Investigator: Michelle A Williams, Sc.D, Swedish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14716-CP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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