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临床试验/NCT02812914
NCT02812914已完成不适用

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Change in 48-hour mean personal carbon monoxide exposure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in 48-hour mean personal carbon monoxide exposure

时间窗: 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

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

时间窗: 1) <20 weeks gestation; 2) 28-32 weeks gestation

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

时间窗: Every month from recruitment to neonatal one month of life (up to 9 months)

Change in 48-hour mean kitchen particulate matter concentration

时间窗: 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

Change in 48-hour mean personal particulate matter exposure

时间窗: 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

次要结局

  • Preterm birth(At time of birth (within 48 hours))
  • Low birth weight(At time of birth (within 48 hours))
  • Respiratory illness(up to one month following birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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