Comparison of intravenous iron isomaltoside versus blood transfusion for treatment of moderate anemia in postpartum women:A Randomised controlled trial.

Anemia is a common problem across all age groups with a higher burden among women anemia is one of the prominent haematological menifestation during pregnancy and post parfumerie period. The post parfumerie period is an often neglected period for the provision of effective care to the mothers Anemia during post natal period is a major public health problem worldwide. Postpartum anemia alters the emotion and cognition and is also associated with postpartum depression. It also plays an important role in decreased milk production and immunity. In India 52% women have some degree of anemia .

There is an increasing concern about the adverse effects of the current transfusion practice Adverse effects of transfusion include increased iatrogenic infections, volume overload and number of immunologic adverse effects and may complicate future transfusions and pregnancies. An alternative treatment is therefore warranted to diminish RBC transfusion related risks in otherwise healthy women with moderate and severe postpartum anemia. Intravenous iron isomaltoside is an alternative to blood transfusions in the management of moderate anemia in postpartum females, as iron deficiency is by far the most common cause of anemia.Iron isomaltoside has an advantage of one dose iron repletion and iron concentration 100mg/ml which is much higher than other iron preparation and no test dose is required.

Jharkhand being one of the underdeveloped states of India has a high burden of postpartum anemia,so study for management of post partum anemia s absolute necessity to combat this problem and help in prevention of morbidity and mortality related to anemia.

Aim of the study is to compare the effectiveness of iron isomaltoside over blood transfusion for treatment of moderate anemia in postpartum females based on changes in hemoglobin level,iron biochemical parameters and resolution of anemic symptoms.

Study population will be all post partum women coming to RIMS labor room and Opd giving consent for the study. Computer generated Random numbers will be used for randomisation and simple randomisation will be used to allocate two groups in equal halves. If iron group will be receiving single dose iron isomaltoside after calculating iron deficit and transfusion group will receive RBC transfusion and will be monitored for any adverse reactions from both which will be immediately managed.

Follow up will be done on day 1post transfusion ,3rd week and 6th week, and hemoglobin levels, iron biochemical parameters and anemic symptoms will be compared.

With this background this study is proposed to evaluate the feasibility and explorative outcomes of high single dose iron isomaltoside compared with RBC transfusion for treatment of moderate postpartum anemia in hemodynamically stable women.