Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India’s anaemia rate is among the highest in the world with India’s National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India’s Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30–34 weeks’ gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 g), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care. Clinical Trials Registry – India CTRI/2020/09/027730. Registered on 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy

中文翻译：

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RAPIDIRON：减少印度孕期贫血——一项 3 组随机对照试验，比较口服铁剂与单剂量静脉铁剂治疗孕妇缺铁性贫血和减少低出生体重分娩的有效性

贫血是一个世界性问题，缺铁是最常见的原因。在怀孕期间，贫血会增加不良孕产妇、胎儿和新生儿结局的风险。印度的贫血率位居世界前列，印度全国家庭健康调查显示，超过 50% 的孕妇患有贫血症。印度的 Anemia Mukt Bharat-Intensified National Iron Plus Initiative 旨在将育龄妇女、青少年和儿童的贫血患病率每年降低 3%，并促进实现全球世界卫生大会 2025 年的目标，即减少 50%育龄妇女贫血。然而，2020 年完成的 NFHS-5 调查的初步结果表明，一些州的贫血率正在上升，这些目标不太可能实现。由于口服铁剂是妊娠期缺铁性贫血 (IDA) 的一线治疗方法，因此这些结果可能会受到副作用、服药依从性差和口服铁剂治疗效果低的影响。这些报告表明，治疗 IDA 的新方法，特别是单剂量静脉输注铁剂的重要性，可能是印度有效实现减少贫血目标的关键。这项 3 臂随机对照试验有能力报告两个主要结果。第一个是评估在妊娠中期早期向中度 IDA 妇女注射单剂两种不同的静脉制剂是否会导致更高比例的参与者在妊娠 30-34 周时达到正常的妊娠 Hb 浓度，或与服用标准剂量口服铁剂的参与者相比，就在分娩前。第二个是低出生体重 (LBW) (< 2500 g) 的临床结果，假设与口服铁臂相比，静脉铁臂中 LBW 分娩的风险较低。RAPIDIRON 试验将提供证据，以确定单剂量静脉输注铁剂在减少妊娠期 IDA 方面是否比目前的标准护理更有效和更经济可行。临床试验注册 - 印度 CTRI/2020/09/027730。