scholarly journals 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.

2021 ◽  
Author(s):  
Richard Derman ◽  
Shivaprasad 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 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

scholarly journals 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 ◽  
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

scholarly journals A study of efficacy of oral iron and intravenous iron sucrose in the treatment of moderate anemia in pregnancy

2019 ◽  
Vol 8 (6) ◽  
pp. 2221
Author(s):  
Saloni M. Prajapati ◽  
Meha K. Patel
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Deficiency Anaemia ◽  
Blood Indices ◽  
In Pregnancy

Background: Iron deficiency anaemia in pregnancy is a common medical problem throughout India with the burden of disease impacting on both mother and the newborn. It is also responsible for increased incidence of premature births, low birth weight babies and high perinatal mortality. Intravenous iron sucrose and oral iron therapy are the primary therapeutic modalities for management of iron deficiency anaemia during pregnancy, but its efficacy during pregnancy is still a matter of argument among healthcare personnel. Therefore the objective of this study is to compare the effect of oral iron and intravenous iron sucrose on hemoglobin and other blood indices among pregnant females with iron deficiency anemia.Methods: Randomized clinical trial was conducted among 400 females between 20 to 34 weeks gestation with iron deficiency anemia who were managed either with oral ferrous sulphate or intravenous iron sucrose therapy. Z test was used for statistical analysis for significance with 95% confidence interval. The hemoglobin and blood indices levels before and after initiating treatment in both groups were compared.Results: Intravenous and oral; both the treatments were associated with increment in hemoglobin but this rise was significantly more in the intravenous group than in oral. Comparing participants with low pretreatment hemoglobin among both groups, participants in the intravenous group were better benefited than oral due to respective treatment.Conclusions: Intravenous iron therapy is much effective in correcting iron deficiency anemia in pregnancy than oral iron therapy. It restores iron stores more promptly. Also intravenous iron is better tolerated compared to oral iron.

scholarly journals A comparative study on efficacy and safety of intravenous iron sucrose and oral iron among anaemic pregnant females

2017 ◽  
Vol 6 (10) ◽  
pp. 4492
Author(s):  
Naheed Zia Khan ◽  
Mufazzal Ahmad ◽  
Akhilesh Dutt Dwivedi ◽  
Mukesh Shukla
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Deficiency Anaemia ◽  
Pregnant Females ◽  
Oral Group ◽  
The Mean ◽  
In Pregnancy

Background: Iron deficiency anaemia (IDA) is the most common medical problem in pregnancy. Both parenteral and oral iron therapies are modalities used for management of anaemia in pregnant females. The present study aimed to compare the efficacy of oral and intravenous iron therapy in improving iron deficiency anaemia in pregnancy and restoring iron stores, compare the pregnancy outcome in the two groups and evaluate their safety.Methods: This prospective randomized clinical trial conducted among pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS (Intravenous Iron Sucrose) or OI (ferrous sulphate). All patients were monitored for laboratory response and adverse effects. Independent sample-t test, Chi square test and ANOVA were used for statistical analysis. P <0.05 was considered significant.Results: From first follow up till the end of the study the mean hemoglobin level of IV Group was found to be significantly higher as compared to that of oral Group. The MCV (mean corpuscular volume) values increased to a significant level in the intravenous group as compare to oral. After therapy increase transferrin saturation in the intravenous group were significantly higher at all-time interval than the oral group. The mean neonatal hemoglobin at birth was significantly higher in IV group 16.88±1.96 gm/dl than oral group 16.88±1.96 (p= p<0.0001).Conclusions: Intravenous iron sucrose is comparatively more efficient in improving haemoglobin than oral iron and has better pregnancy outcomes.

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