A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Simon Fraser University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ryan Allen, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01741051
First received: November 30, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to use an air filter intervention to evaluate the relationship between particulate matter air pollution exposure during pregnancy and fetal growth. We hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major reductions in home indoor concentrations of particulate matter and 2) pregnant women whose exposures to particulate matter are reduced by this intervention will give birth to children with greater mean body weight for gestational age.


Condition Intervention
Fetal Growth Restriction
Device: HEPA Filter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Gestational-age adjusted birthweight [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Birthweight [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Gestational age [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Head circumference [ Time Frame: At birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: At approximately 10, 11, 30 and 31 weeks gestation ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: At approximately 10 and 30 weeks gestation ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEPA Filter
HEPA filter placed in the participant's home from approximately 10 weeks gestation until birth.
Device: HEPA Filter
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (>18 years)
  • Pregnant woman in first trimester (<14 weeks)
  • Single gestation pregnancy
  • Non-smoker

Exclusion Criteria:

  • Multiple-gestation pregnancy
  • Current smoker
  • Currently operating an air filter in the home
  • Currently living in a ger (traditional Mongolian felt-lined yurt)
  • Plan to give birth outside of a hospital or clinic in Ulaanbaatar
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741051

Contacts
Contact: Ryan Allen, PhD 778 782-7631 allenr@sfu.ca

Locations
Mongolia
Health Sciences Univiersity of Mongolia Recruiting
Ulaanbaatar, Mongolia
Contact: TBD         
Principal Investigator: Enkhjargal Gombojav, PhD         
Sponsors and Collaborators
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Ryan Allen, Associate Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01741051     History of Changes
Other Study ID Numbers: 275997
Study First Received: November 30, 2012
Last Updated: April 10, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Simon Fraser University:
Air pollution
Particulate matter
Mongolia
Pregnancy
Intrauterine growth restriction (IUGR)
Fetal growth
Birth weight
Gestational age

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014