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Clinical Trials/NCT02394574
NCT02394574CompletedNot Applicable

Household Air Pollution and Pregnancy Outcome

University of Chicago1 site in 1 country307 target enrollmentStarted: September 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
307
Locations
1
Primary Endpoint
Adverse Pregnancy Outcomes

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
— to 35 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Adverse Pregnancy Outcomes

Time Frame: At birth

(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.

Secondary Outcomes

  • Reduction in personal exposure to PM2.5, CO and PAH(At birth)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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