Abstract
BackgroundAnaemia 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.MethodsThis 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.DiscussionThe 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.Trial registrationClinical 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
Highlights
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 iron deficiency anaemia (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
Background and rationale {6a} Anaemia is a worldwide problem with iron deficiency anaemia (IDA) being the most common cause [1]
Summary
Background and rationale {6a} Anaemia is a worldwide problem with iron deficiency anaemia (IDA) being the most common cause [1]. Anaemia increases the risk of adverse maternal, foetal and neonatal outcomes [2, 3]. 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, the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its Derman et al Trials (2021) 22:649 targets for anaemia reduction
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