Household Air Pollution and Pregnancy Outcome

Pregnancy Clinical Trial

— HAP  

Official title:

Household Air Pollution and Pregnancy Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02394574
• Other study ID #: 12-1460
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2025

Study information

• Verified date: December 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Clean Cookstove
Ethanol
• Traditional Cookstove
Firewood / Kerosene

Locations

Country	Name	City	State
Nigeria	College of Medicine. University of lbadan, Ibadan	Ibadan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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