Household Air Pollution and Pregnancy Outcome (HAP)

October 11, 2024 updated by: University of Chicago
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • College of Medicine. University of lbadan, Ibadan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 31 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Christopher Olopade, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimated)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 12-1460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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