Waterless Hand Cleansing With Chlorhexidine During the Perinatal Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times
研究概览
简要总结
Background (brief):
- Burden:
Neonatal death still unacceptably high in low income countries. The common causes of neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur because the mother's hands or the hands of the person who attended the birth are unclean. Our previous study found that there was substantial concern about excessive exposure of the mother or the neonate to water during handwashing because of the perception that frequent contact with water could lead to respiratory illness. 2. Knowledge gap:
Chlorhexidine has been evaluated for use in hand hygiene applications in high-income countries, particularly in healthcare, but it has not been evaluated or promoted for hand cleansing at the household level in low- and middle-income countries. 3. Relevance:
A waterless hand cleanser employing chlorhexidine would overcome important barriers to handwashing with soap, perceptions of cold resulting from exposure to water, and the time limitations perceived by mothers.
Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention will clean their hands (with chlorhexidine or soap and water) more frequently than mothers who are not exposed to the chlorhexidine-based hand cleansing program.
Objectives:
The primary objective
- To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention on hand cleansing of mothers during the neonatal period The secondary objectives
- To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand cleansing of other family members, visitors to the neonate, and birth attendants during the neonatal period
- To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period among mothers, other family members, and birth attendants
Methods:
We propose a randomized controlled trial in a rural area of Bangladesh, with an active control. Randomization will be at the level of the participating pregnant woman. Each arm will include 150 participants. All intervention visits will follow baseline data collection. A trained health and hygiene promoter will carry out two visits in the antenatal period and one postnatal visit to deliver intervention messages.
Outcome measures:
- Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times.
- Observed hand cleansing behavior of other household members and visitors to home with chlorhexidine or soap and water at critical times.
详细描述
Neonates (babies < 28 days old) die at unacceptably high rates (26deaths per 1000 live births) in many resource-limited countries, accounting for about 40% of deaths among all children under 5 years old. Infections such as pneumonia, sepsis, and omphalitis are common causes of neonatal death. Many neonatal infections occur because the mother's hands or the hands of the person who attended the birth are unclean. In Nepal, newborns who survived were significantly more likely than newborns who died to have mothers reporting handwashing, and birth attendants who were reported to wash hands before the delivery. But, mothers and birth attendants often do not wash their hands, despite the vulnerability of the neonatal period.
The traditional approach to improving handwashing among caregivers of young children is to teach about critical times to wash hands and how to wash hands. This narrow, prescriptive approach ignores the barriers to hand hygiene unique to the Perinatal and neonatal periods. Moreover, our qualitative findings suggest that frequent handwashing with water may not be acceptable. That is, both mothers and birth attendants reported that, when mothers come into contact with water frequently (e.g. by washing hands often), the newborn child is at risk of developing upper and lower respiratory infection. A novel technological solution - one that provides efficiency and portability and obviates the need for washing with water - may overcome important obstacles to improving hand cleansing behavior in the neonatal period.
During the discrete time frame of the neonatal period, chlorhexidine for hand cleansing represents a focused intervention with substantial potential for scalability. The shelf-life of chlorhexidine is long (2-3 years), facilitating its scaling up and efficient distribution, for example, in clean delivery kits that are provided to low-income mothers throughout resource-limited countries.
Given the potential for this low-technology solution to break through critical barriers to handwashing with water and soap, and markedly reduce neonatal mortality, we propose to conduct a randomized controlled trial to evaluate the impact of a chlorhexidine-based hand cleansing intervention on maternal, familial, and birth attendant hand cleansing behavior in the peripartum and neonatal periods.
Methods Study design
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women older than 18 years that are at 32-36 weeks gestation and intend to reside in the location which they are residing at the time of recruitment into the study through the remainder of the antenatal period and the first 4 weeks after birth.
排除标准
- •Plans to move out of study area between enrollment and 1 month after birth.
结局指标
主要结局
Observed hand cleansing behavior of mother with chlorhexidine or soap and water at critical times
时间窗: 1 week and one month after birth
We will observe hand cleansing behavior of mother through 3 hours structured observations.
次要结局
- Observed hand cleansing behavior of other household members and visitors to home with chlorhexidine or soap and water at critical times(1 week and one month after birth)