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Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia

Sponsor: ESI-PGIMSR, Basaidarapur

Summary

The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb \>7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index \>13. Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb \>11 g/dl at 4 and 6 weeks. Percentage of patients achieving Hb rise \>3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron. Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done. Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks. All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.

Official title: Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Treatment of Post Partum Iron Deficiency Anaemia

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