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

S

Simon Fraser University

Status

Completed

Conditions

Fetal Growth Restriction

Treatments

Device: HEPA Filter

Study type

Interventional

Funder types

Other

Identifiers

NCT01741051
275997

Details and patient eligibility

About

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. In an extended follow-up of this cohort, we aim to evaluate the relationship between use of portable air purifiers during pregnancy and the growth and development of children from birth to age four years. In particular, the follow-up study will focus on children's physical growth, respiratory symptoms, and behavioral, social and neurocognitive development.

Enrollment

540 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

540 participants in 2 patient groups

HEPA Filter
Experimental group
Description:
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Treatment:
Device: HEPA Filter
Control
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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