Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial

Publication date: December 2019Source: The Lancet Global Health, Volume 7, Issue 12Author(s): Sutapa B Neogi, Niveditha Devasenapathy, Ranjana Singh, Himanshu Bhushan, Duru Shah, Hema Divakar, Sanjay Zodpey, Sunita Malik, Smiti Nanda, Pratima Mittal, Achla Batra, Meenakshi B Chauhan, Sunita Yadav, Harsha Dongre, Sumita Saluja, Vani Malhotra, Anjali Gupta, Roopa Sangwan, A G Radhika, Alpana SinghSummaryBackgroundIntravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.MethodsWe did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20–28 weeks of gestation with a haemoglobin concentration of 5–8 g/dL, or at 29–32 weeks of gestation with a haemoglobin concentration of 5–9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripart...
Source: The Lancet Global Health - Category: International Medicine & Public Health Source Type: research