A multicomponent intervention to reduce home-exposure to second-hand smoke (SHS) during pregnancy and postnatal period: a randomised controlled trial

南亚是世界上男性吸烟人数最多的地区之一。因此，南亚超过三分之一的孕妇在家中暴露于二手烟。这对母亲（如心脏和肺部相关疾病增加）以及新生儿（死产，早产和肺部相关疾病的可能性增加）都有严重的健康后果。另一方面，产前阶段为改变整个家庭中与健康有关的行为提供了一个机会之窗。有效减少孕妇接触二手烟的干预措施已在较富裕国家成功试用，但尚未在中低收入国家大规模实施。我们提出的项目解决了两个这样的国家-城市班加罗尔，印度和城市周边的科米拉，孟加拉国的这一差距。这些地点位于全球二手烟影响造成的疾病负担最重的地区。该项目有两个广泛的目标：第一个目标是将关于已知有效措施的现有知识转化为可以向妇女及其家庭成员提供的可接受和可行的干预措施。这可能包括让妇女及其家人了解通过简单的唾液测试测得的她体内的二手烟含量;教育全家人了解二手烟对母亲和婴儿的有害影响;并利用“沟通-* 利用心理学和行为科学领域的“技术”，鼓励丈夫和其他家庭成员改变怀孕母亲的吸烟习惯，存在感第二个目标是应用科学方法来测试这一干预措施在减少孕妇和新生儿接触二手烟方面的有效性，并确定实施这一干预措施的成本效益。该项目将分两个阶段进行。在第一阶段（发展阶段：0-12个月），我们将采访孕妇，她们的丈夫和其他家庭成员，深入了解家庭中二手烟问题的所有问题，包括我们在试图改变这一点时可能面临的障碍。我们将利用这些信息制定一种干预措施，以可接受的方式克服这些障碍。在这一阶段，我们还将帮助印度和孟加拉国的同行获得开发此类干预措施所需的专业知识，并帮助他们掌握测试这些干预措施的科学方法。在第二阶段（试验阶段-第13-36个月），我们将进行一项严格的科学实验（称为随机对照试验），将我们的新干预措施与通过传单进行的二手烟教育进行比较。我们将确定920名在家中暴露于二手烟的早孕母亲（每个站点460名），接受干预或仅接受教育传单。这样做的方式是，每个妇女都有平等的机会进入任何一个群体。我们将收集所有这些母亲和家庭的信息，当我们招募他们进入我们的研究，然后在怀孕后期，3个月后，两组都接受了两种干预措施之一。我们还将在新生儿出生时以及出生后3个月收集信息。收集的资料包括怀孕和分娩的情况、透过唾液测试母婴体内的二手烟含量、母婴健康状况，以及家庭成员的吸烟行为。我们将比较两组中收集的信息，看看干预效果如何。我们还将从一些家庭收集更详细的信息，以了解干预是如何工作的（或在某些情况下失败）。研究结果将在整个项目期间与关键的学术、政策和社区利益攸关方分享。

South Asia has one of the highest numbers of male smokers anywhere in the world. As a result, over a third of pregnant women in South Asia are exposed to second-hand smoke in their homes. This has serious health consequences for both mothers (such as increased heart- and lung-related illnesses) as well as the newborn (higher chances of stillbirth, being born prematurely and lung-related illnesses). On the other hand, the antenatal period provides a window of opportunity to change health-related behaviours in the entire family. Interventions that are effective in reducing the exposure of pregnant women to second-hand smoke have been tried successfully in richer countries but have not been adapted for large-scale implementation in lower and middle-income countries. Our proposed project addresses this gap in two such countries - urban Bangalore, India and peri-urban Comilla, Bangladesh. The sites are situated in a region with the greatest burden of disease from the effects of second-hand smoke globally. The project has two broad aims: The first is to adapt existing knowledge about what is known to work, into an acceptable and feasible intervention that can be delivered to the woman and her family members. This may include informing the woman and her family about the levels of second-hand smoke in her body measured by a simple test on her saliva; educating the whole family about the harmful effects of second-hand smoke on the mother and baby; and using 'communication-techniques' from the field of psychology and behavioural sciences to encourage husband and other family members to change the habit of smoking in the pregnant mother's presence. The second aim is to apply scientific methods to test the effectiveness of this intervention in reducing the exposure of pregnant women and newborn to second-hand smoke in both sites, and to determine the costs versus benefits of implementing such an intervention. The project will be undertaken in two phases. In Phase 1 (Development Phase: Months 0-12), we will interview pregnant women, their husbands, and other family members to gain an in-depth understanding of all the issues surrounding the problem of second-hand smoke in the household, including barriers we may face in trying to change this. We will use this information to develop an intervention that can overcome these barriers in an acceptable way. During this phase, we will also help our Indian and Bangladeshi counterparts gain the expertise needed to develop such interventions, and in scientific methods to test them. In Phase 2 (Trial Phase - Months 13-36), we will conduct a strict scientific experiment (called a randomized controlled trial) to compare our new intervention with education about second-hand smoke through a leaflet. We will identify 920 mothers in early pregnancy, who are exposed to second hand smoke at home (460 at each site), to receive either the intervention or only the educational leaflet. This will be done in a way that each woman has an equal chance of being in either group. We will collect information on all these mothers and families when we recruit them into our study and then in late-pregnancy, 3 months after both groups have received either of the two interventions. We will also collect information when the new baby is born, and then 3 months after his/her birth. The information collected will include how the pregnancy and birth fared; levels of second-hand smoke in the mothers' and infants' body through a test on their saliva; health of both mother and baby, and smoking behaviours of family members. We will compare the information collected in the two groups to see how well the intervention did. We will also collect more detailed information from some families to understand how the intervention worked (or failed to work, in some cases). The findings from the study will be shared with key academic, policy and community stakeholders throughout the duration of the project.