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Completed

NCT Number: NCT02812914

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

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.

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Key information

Conditions

Premature Birth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Exposure to Environmental Pollution, Non-occupational Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Infant, Small for Gestational Age Infections Infections, Respiratory Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Lorenzo Health Center

San Lorenzo, Guatemala

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-cost gas stove

Other

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

Peer education classes

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations

    Time frame: 1) <20 weeks gestation; 2) 28-32 weeks gestation

  2. Change in 48-hour mean personal carbon monoxide exposure

    Time frame: 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

  3. Change in 48-hour mean kitchen particulate matter concentration

    Time frame: 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

  4. Change in 48-hour mean personal particulate matter exposure

    Time frame: 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

  5. Change in weekly use of gas stoves (cooking events and total cooking time) using temperature loggers

    Time frame: Every month from recruitment to neonatal one month of life (up to 9 months)

Secondary outcomes

  1. Preterm birth

    Time frame: At time of birth (within 48 hours)

  2. Low birth weight

    Time frame: At time of birth (within 48 hours)

  3. Respiratory illness

    Time frame: up to one month following birth

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Universidad del Valle, Guatemala

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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