NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

Premature Birth Clinical Trial

Official title:

NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812914
• Other study ID #: 15-17003
• Status: Completed
• Phase: N/A
• First received: June 3, 2016
• Last updated: October 25, 2017
• Start date: April 2016
• Est. completion date: June 19, 2017

Study information

• Verified date: October 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and pneumonia, are associated with high exposures to household air pollution during pregnancy and early infancy. The proposed study will assess the feasibility and acceptability of an introduced liquid petroleum gas stove, complemented by two alternative approaches to delivering tailored behavioral change interventions, among pregnant women and their neonates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant woman less than 20 weeks gestation

• Does not smoke cigarettes

• Uses an open fire or deteriorated woodstove for cooking

• Purchases wood

• Intends to stay in the study area for at least one year

• Uses Ministry of Health clinics for routine prenatal care

• Has a mobile phone

• Primary person responsible for cooking in the household

• Able to give Informed Consent

Exclusion Criteria:

• Multiple pregnancy (eg twins)

• Identified as a high-risk pregnancy by physician

• Regularly taking prescription medication

• Smokes cigarettes

• Routinely carries a child less than 2 years old on their back

Related Conditions & MeSH terms

• Exposure to Environmental Pollution, Non-occupational
• Fetal Growth Retardation
• Infant, Small for Gestational Age
• Infections, Respiratory
• Premature Birth
• Respiratory Tract Infections

Intervention

Other:
• Low-cost gas stove
Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas

Behavioral:
• Peer education classes
Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution
• Resource-intensive behavioral intervention approach
Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution. Additionally, peer educators will visit each home after group classes to help the woman, and key decision-makers in her family, identify top priority strategies to reduce air pollution. Using a checklist, peer educators will observe whether household members are adhering to tailored strategies at subsequent home visits, and provide ongoing support to women and their families.

Locations

Country	Name	City	State
Guatemala	San Lorenzo Health Center	San Lorenzo

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Universidad del Valle, Guatemala

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations		1) <20 weeks gestation; 2) 28-32 weeks gestation
Primary	Change in 48-hour mean personal carbon monoxide exposure		1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life
Primary	Change in 48-hour mean kitchen particulate matter concentration		1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life
Primary	Change in 48-hour mean personal particulate matter exposure		1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life
Primary	Change in weekly use of gas stoves (cooking events and total cooking time) using temperature loggers		Every month from recruitment to neonatal one month of life (up to 9 months)
Secondary	Preterm birth		At time of birth (within 48 hours)
Secondary	Low birth weight		At time of birth (within 48 hours)
Secondary	Respiratory illness		up to one month following birth