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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fetal Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HEPA Filter

HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.

Group Type EXPERIMENTAL

HEPA Filter

Intervention Type DEVICE

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HEPA Filter

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes