NDLI: A community-based cluster randomised controlled trial in rural Bangladesh to evaluate the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality: the Shonjibon trial

Content Provider	Springer Nature : BioMed Central
Author	Huda, Tanvir M. Rahman, Mohammad Masudur Raihana, Shahreen Islam, Sajia Tahsina, Tazeen Alam, Ashraful Agho, Kingsley Rasheed, Sabrina Hayes, Alison Karim, Mohd Anisul Rahman, Qazi Sadequr Siddique, Abu Bakkar Moinuddin, Md Chowdhury, Morseda Ghose, Lucky Afsana, Kaosar Raynes-Greenow, Camille El Arifeen, Shams Dibley, Michael J.
Abstract	Background 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. Discussion 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. Trial registration This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 31 May 2012. The registration ID is ACTRN12612000588897 .
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-018-5713-1.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-018-5713-1
Journal	BMC Public Health
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2018-07-03
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health Iron-folic Acid Supplements Neonatal Mortality Rural Bangladesh Neonatal Death High Iron Requirement Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

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