Intervening to Improve Birth Weight and Infant Respiratory Health in Rural Ghana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,414
- 试验地点
- 2
- 主要终点
- Low birth weight
研究概览
简要总结
The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies.
The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana.
Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns.
Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first 12 months of life.
详细描述
- Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study is a three-arm cluster randomized trial, with two intervention arms and a control arm. The primary justification for intervening at the village level is that an individual level randomization, which would entail treatments and controls living side-by-side in a village, could lead to conflict within villages.
2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of Kintampo Health Research Centre. This comprises a population of 146,000. The study population is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area is well described in Owusu-Agyei et al. 2012 (38).
A cluster was eligible to participate if it:
- Is located in Kintampo North or South Districts (this is the core study area for KHRC)
- Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
- Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
- Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).
A woman will be eligible to participate in the study if she:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Biolite Cook Stove
Provision of two cook stoves to each subject. Each stove burns wood fuel, but more efficiently than a traditional three stone fire.
干预措施: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel (Other)
LPG Cook Stove
Provision of a two-burner liquified petroleum gas stove to each subject, along with fuel needed for the family during the follow up period.
干预措施: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel (Other)
Control
结局指标
主要结局
Low birth weight
时间窗: Birth
次要结局
- Acute lower respiratory disease(12 months)