Household Air Pollution and Pregnancy Outcome

Study Overview
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Brief Summary
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Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health effects has been hindered by lack of accurate data on exposure and health outcomes. There are few studies available that report HAP exposures and development of adverse pregnancy outcomes from households using biomass fuels.

Official Title
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Household Air Pollution and Pregnancy Outcome

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Clean Cookstove
* Other: Traditional Cookstove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who present to the hospital Who cook exclusively with either kerosene or firewood Before the fourteenth week of pregnancy as determined by ultrasound imaging Exclusion Criteria: Smoking women or women with smoking family members Women with a high-risk pregnancy defined as: Women with uncontrolled hypertension Women greater than 35 years old carrying their first child Women having triplets or more Women who have had a previous C-section Women carrying babies with fetal abnormalities or as determined by the obstetrician.

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clean Cookstove<br>Subjects will use ethanol stoves using bioethanol | Other: Clean Cookstove<br>* Ethanol<br>|
| Other: Traditional Cookstove<br>Subjects will use traditional firewood or kerosine cookstove and receive education on how to reduce air pollution exposures | Other: Traditional Cookstove<br>* Firewood / Kerosene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Pregnancy Outcomes | (first trimester miscarriages, intrauterine growth retardation, low birth weight (300gm less weight in controls relative to intervention group, premature deliveries (deliveries before 37 weeks of pregnancy) and still births. | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in personal exposure to PM2.5, CO and PAH | Reduction in personal exposure to PM2.5, CO and PAH in the Ethanol intervention group relative to the control (kerosene/firewood) group | At birth |