#Generic iv iron writedown trial

#Generic iv iron writedown trial

Ethical clearance was obtained from the institute's ethics committee (IEC), and the trial was registered with the Clinical Trial Registry of India (REF/2013). The study was conducted as a parallel-group, open-label randomized controlled trial (RCT) in the Department of Obstetrics and Gynecology of a tertiary care government hospital in India, with approximately 4,000 delivery loads annually. This study discusses the effectiveness and practical aspect of using both, which seems to be the better out of both, and why. To answer this, a randomized control trial comparing both the treatment options in a tertiary care government hospital was set up in the hilly terrains of India. The management becomes a concern in the pregnancy where the question arises of which is better the intravenous iron sucrose or the oral ferrous sulfate tablets. Individual selection of the appropriate iron therapy and evaluation of treatment response are mandatory to safely deliver improved outcome through intravenous iron therapies.Īnemia among pregnant women is one of the major health concerns for healthcare workers. These biochemical changes can cause severe and potentially irreversible clinical complications, such a bone pain, osteomalacia and fractures. iron is an improvement of the quality of life, for which hemoglobin is a surrogate marker.Īn emerging complication affecting 50–74% of patients treated with ferric carboxymaltose in prospective clinical trials is hypophosphatemia – or more accurately the 6H syndrome (hyperphosphaturic hypophosphatemia triggered by high fibroblast growth factor 23 that causes hypovitaminosis D, hypocalcemia and secondary hyperparathyroidism). In patients with inflammation, iron-deficiency should also be suspected as anemia cause when transferrin saturation is low because serum ferritin can be spuriously normal. As per European drug label, intravenous iron may also be preferred when rapid correction of the iron deficit is required. Hence, intravenous iron therapy is reserved for iron deficiency anemia patients with intolerance or unresponsiveness of oral iron. In recent prospective clinical trials, the risk of moderate to severe infusion reactions was comparable among all modern preparations affecting <1% of patients. All iron preparations are associated with a risk of severe infusion reactions. Iron dextran, iron derisomaltose (formely known as iron isomaltoside 1000), ferric carboxymaltose, ferrumoxytol, iron sucrose and sodium ferric gluconate can be infused at different doses and allow correction of total iron deficit with single or repeated doses in 1–2 weeks depending on the specific formulation. Modern iron formulations are composite nanoparticles composed of carbohydrate ferric oxy-hydroxides. Intravenous infusions of iron have evolved from a poorly effective and dangerous intervention to a safe cornerstone in the treatment of iron deficiency.