A Randomized Controlled Trial to Compare Intraveous Ferric Carboxymaltose with Oral Iron for Treatment of Post-Partum Anemia

Abstract

Objectives: To compare the efficacy of ferric carboxymaltose (FCM) with oral iron in management of post-partum anemia. Materials and Methods: A total of 230 post-partum women aged >18 years having Hb level <10 g/dl on post-natal day 1 were randomized to receive either oral iron (ferrous fumarate tablets 200 mg for 06 weeks) or intravenous FCM (dose calculated by Ganzoni’s Formula, total iron dose = [actual body weight x (15 - actual Hb)] x 2.4 + iron stores). Demographic, obstetric and hematological profile (Hb and serum iron profile) was estimated at the time of enrolment. The women were followed up after six weeks. Non-complying women were excluded from the study. Change in Hb levels, serum iron profile and number of women achieving Hb>10 g/dl was noted. Data was compared using Chi-square and Independent samples ‘t’-test respectively. Results: A total of 218 women (107 in FCM and 111 in oral iron group) completed the study. Mean age of women was 26.67±4.31 years. Mean pre-intervention Hb level was 9.11±0.62 and 9.15±0.61 g/dl respectively in FCM and oral iron groups (p=0.630). At follow-up these values were 11.11±0.89 and 10.78±0.88 g/dl respectively in the corresponding groups (p=0.006). Mean change in Hb level and number of women achieving targeted Hb level were significantly higher in FCM as compared to that in oral iron group (p<0.05). Serum iron reserves were also found to be significantly higher in FCM as compared to oral iron group. Conclusion: Intravenous FCM had an edge over oral iron in management of post- partum anemia.