Original Articles
Comparitive study of the efficacy and safety of Iron isomaltoside versus Iron sucrose in Iron deficiency anaemia of pregnancy | |
Supriya Sharma, Akshita Gupta, Sonia | |
Background: Anaemia is the most common medical disorder during pregnancy.1 About 36.5 % of pregnant women worldwide are anaemic. The prevalence of Iron deficiency anaemia in pregnancy in India ranges from 23.6%-61.4%. Therefore to handle this burden new iron formulations need to be evaluated, including parentral forms as many patients are noncompliant and intolerant to oral iron. Materials & Methods: a prospective, comparative, open-label, randomized, single center trial conducted in the post graduate department of Obstetrics and Gynaecology, S.M.G.S Hospital, GMC Jammu over a period of one year with the aims of comparing the efficacy , safety and tolerability of iron isomaltoside vs iron sucrose in pregnant females suffering from iron deficiency anaemia. 100 pregnant females between gestational age of 28- 36 weeks, Hb 7-9.9 g/dl, serum ferritin levels <30 mcg/l were selected and divided into 2 groups of 50 each after 1:1 randomisation and labelled as Group A - Iron isomaltoside group and Group B-Iron sucrose group. Haemoglobin levels (g/dl) and serum ferritin (mcg/L) were checked pretreatment and at 2 weeks and 4 weeks of treatment to compare the 2 groups. Side effects were also observed for and statistical analysis was done using appropriate tests. Results: Post treatment, at 2 weeks mean rise in Hb was 0.9 ± 0.3g/dl vs 0.3 ± 0.14 g/dl (p<0.0001) and at 4 weeks, 1.64 vs 1.03g/dl) (p<0.0001) in Group A & B. At two weeks post-treatment, mean total serum ferritin level was significantly higher in Group A as compared to that of Group B (157 vs 86 mcg/L ; p<0.0001).Similarly after four weeks post-treatment, mean total serum ferritin level was also significantly higher in Group A as compared to that of Group B (133.86 vs 83.6 mcg/L; p<0.0001). Adverse reactions were observed in 16% patients in each group. Conclusion: Iron Isomaltoside should be used as a first line treatment to bring about a revolution in the management of iron deficiency anaemia of pregnancy as it is safe and more efficacious than Iron sucrose |
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