A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy

Abstract Background: 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. Methods: 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 grams), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. Discussion: 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.Trial registration: Clinical Trials Registry – India: CTRI/2020/09/027730. Registered 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy

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RAPIDIRON: Reducing Anaemia in Pregnancy in India—a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries

Trials ◽

10.1186/s13063-021-05549-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Richard J. Derman ◽

Shivaprasad S. Goudar ◽

Simal Thind ◽

Sudhir Bhandari ◽

Zubair Aghai ◽

...

Keyword(s):

Single Dose ◽

Iron Deficiency ◽

Iron Deficiency Anaemia ◽

Controlled Trial ◽

Intravenous Iron ◽

Oral Iron ◽

Reproductive Age ◽

Deficiency Anaemia ◽

Randomized Controlled ◽

In Pregnancy

Abstract Background 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. Methods 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. Discussion 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. Trial registration 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

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Effect of oral versus parenteral therapy to improve the Hb level among antenatal women with iron deficiency anaemia: A randomized controlled trial

IOSR Journal of Dental and Medical Sciences ◽

10.9790/0853-0830811 ◽

2013 ◽

Vol 8 (3) ◽

pp. 08-11

Author(s):

Arpita Goen ◽

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Deficiency Anaemia ◽

Controlled Trial ◽

Parenteral Therapy ◽

Deficiency Anaemia ◽

Randomized Controlled

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P485 IV iron treatment of iron deficiency anaemia with Ferumoxytol in patients with gastrointestinal disorders unable to take oral iron: a randomized controlled trial versus iron sucrose

Journal of Crohn s and Colitis ◽

10.1016/s1873-9946(13)60506-1 ◽

2013 ◽

Vol 7 ◽

pp. S204 ◽

Cited By ~ 2

Author(s):

D. Hetzel ◽

W. Strauss ◽

K. Bernard ◽

J. Li ◽

L. Allen

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Deficiency Anaemia ◽

Controlled Trial ◽

Iron Sucrose ◽

Gastrointestinal Disorders ◽

Deficiency Anaemia ◽

Randomized Controlled ◽

Iron Treatment ◽

Iv Iron

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Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0041-1740003 ◽

2021 ◽

Author(s):

Adam K. Lewkowitz ◽

Molly J. Stout ◽

Emily Cooke ◽

Seon C. Deoni ◽

Viren D'Sa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Adverse Reactions ◽

Controlled Trial ◽

Oral Iron ◽

Deficiency Anemia ◽

Randomized Controlled ◽

Iv Iron ◽

Severe Adverse Reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

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