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

• DOI: 10.1186/s12889-018-5713-1
• Publication Date: 2018-07-03T05:10:40Z
• Authors: Tanvir M. Huda; Mohammad Masudur ...; Shahreen Raihana; Sajia Islam; Tazeen Tahsina; Ashraful Alam; Kingsley Agho; Sabrina Rasheed; Alison Hayes; Mohd Anisul Karim; Qazi Sadequr Rahman; Abu Bakkar Siddique; Md Moinuddin; Morseda Chowdhury; Lucky Ghose; Kaosar Afsana; Camille Raynes-Gr...; Shams El Arifeen; Michael J. Dibley
• Keywords: Rural Population; Epidemiology; FOS: Health sciences; Infant mortality; 310; Pediatrics; Study Protocol; iron; 0302 clinical medicine; Pregnancy; Infant Mortality; Internal medicine; Global Maternal and Child Health Outcomes; 2. Zero hunger; Bangladesh; Nutrition and Dietetics; Regulation of Iron Metabolism and Anemia; Anemia, Iron-Deficiency; Anemia; Hematology; 3. Good health; Environmental health; Randomized controlled trial; Cluster randomised controlled trial; Medicine; Female; pregnancy; Public aspects of medicine; RA1-1270; Adult; Iron; Population; Nursing; folic acid; 03 medical and health sciences; Folic Acid; XXXXXX - Unknown; newborn infants; Health Sciences; Genetics; Humans; Biology; Maternal and Child Nutrition in Developing Countries; Iron deficiency; Infant, Newborn; Infant; Pregnancy Complications; therapeutic use; FOS: Biological sciences; Dietary Supplements; Pediatrics, Perinatology and Child Health; Iron Deficiency; Surgery

Iron-deficiency is the most common nutritional deficiency globally. Due to high iron requirements for pregnancy, it highly prevalent and severe in pregnant women. There strong evidence that maternal anaemia increases risk of adverse perinatal outcomes. However, from observational epidemiological studies except a very few randomised controlled trials. IFA supplements have also been found reduce preterm delivery rate neonatal mortality attributable prematurity birth asphyxia. These results combined indicate populations iron-deficient women could lead decrease number deaths mediated by reduced rates delivery. In this paper, we describe protocol community-based cluster trial aims evaluate impact antenatal on The effect early use iron-folic acid will be examined using community based, five districts with 30,000 live births. intervention clusters trained BRAC village volunteers identify & provide supplements. Groundwater levels measured all study households validated test kit. analysis follow intention treat principle. We compare their 95% confidence intervals adjusted clustering between treatment groups each groundwater iron-level group. Cox proportional hazards mixed models used outcomes include level as an interaction term model. This paper based evaluating pregnancy mortality. critical because determine if commenced first trimester rather than later, significantly month life, approach cost-effective. has registered Australian New Zealand Clinical Trials Registry (ANZCTR) 31 May 2012. registration ID ACTRN12612000588897 .