School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
BMC Public Health. 2018 Jul 3;18(1):816. doi: 10.1186/s12889-018-5713-1.
Iron-deficiency is the most common nutritional deficiency globally. Due to the high iron requirements for pregnancy, it is highly prevalent and severe in pregnant women. There is strong evidence that maternal iron deficiency anaemia increases the risk of adverse perinatal outcomes. However, most of the evidence is from observational epidemiological studies except for a very few randomised controlled trials. IFA supplements have also been found to reduce the preterm delivery rate and neonatal mortality attributable to prematurity and birth asphyxia. These results combined indicate that IFA supplements in populations of iron-deficient pregnant women could lead to a decrease in the number of neonatal deaths mediated by reduced rates of preterm delivery. In this paper, we describe the protocol of a community-based cluster randomised controlled trial that aims to evaluate the impact of maternal antenatal IFA supplements on perinatal outcomes.
METHODS/DESIGN: The effect of the early use of iron-folic acid supplements on neonatal mortality will be examined using a community based, cluster randomised controlled trial in five districts with 30,000 live births. In intervention clusters trained BRAC village volunteers will identify pregnant women & provide iron-folic acid supplements. Groundwater iron levels will be measured in all study households using a validated test kit. The analysis will follow the intention to treat principle. We will compare neonatal mortality rates & their 95% confidence intervals adjusted for clustering between treatment groups in each groundwater iron-level group. Cox proportional hazards mixed models will be used for mortality outcomes & will include groundwater iron level as an interaction term in the mortality model.
This paper aims to describe the study protocol of a community based randomised controlled trial evaluating the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality. This study is critical because it will determine if antenatal IFA supplements commenced in the first trimester of pregnancy, rather than later, will significantly reduce neonatal deaths in the first month of life, and if this approach is cost-effective.
This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 31 May 2012. The registration ID is ACTRN12612000588897 .
缺铁是全球最常见的营养缺乏症。由于妊娠期间铁需求量高，孕妇缺铁性贫血的患病率和严重程度都很高。有强有力的证据表明，母体缺铁性贫血会增加不良围产期结局的风险。然而，除了极少数随机对照试验外，大多数证据都来自观察性流行病学研究。铁叶酸补充剂也已被发现可降低早产率和新生儿死亡率，归因于早产和出生窒息。这些结果表明，在缺铁的孕妇人群中补充铁叶酸可能会通过降低早产率来减少新生儿死亡人数。在本文中，我们描述了一项基于社区的整群随机对照试验的方案，该试验旨在评估孕妇产前铁叶酸补充剂对围产期结局的影响。
方法/设计：采用基于社区的整群随机对照试验，在 5 个有 30000 例活产的地区评估早期使用铁叶酸补充剂对新生儿死亡率的影响。在干预组中，经过培训的 BRAC 乡村志愿者将识别孕妇并提供铁叶酸补充剂。使用经过验证的检测试剂盒在所有研究家庭中测量地下水铁含量。分析将遵循意向治疗原则。我们将比较每组新生儿死亡率及其 95%置信区间，调整各组的地下水铁水平。将使用 Cox 比例风险混合模型对死亡率结果进行分析，并在死亡率模型中包含地下水铁水平作为交互项。
本文旨在描述一项基于社区的随机对照试验的研究方案，该试验评估了在妊娠早期使用铁叶酸补充剂对新生儿死亡率风险的影响。这项研究至关重要，因为它将确定在妊娠早期（而非晚期）开始使用产前铁叶酸补充剂是否会显著降低新生儿在生命的第一个月内的死亡人数，以及这种方法是否具有成本效益。
该试验于 2012 年 5 月 31 日在澳大利亚和新西兰临床试验注册中心（ANZCTR）注册。注册号为 ACTRN12612000588897。
