Intravenous ferrous sucrose versus placebo in addition to oral iron therapy for the treatment of severe postpartum anaemia: a randomised controlled trial

Objective The aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia. Design A randomised, double-blind, parallel-group, placebo-controlled clinical trial was performed in a single centre. Setting Hospital Clinic of Barcelona, Barcelona, Spain. Population A cohort of 72 women with severe postpartum anaemia (6.0-8.0g/dl) treated with oral ferrous sulphate (two tablets of 525mg). Methods Women were randomised to receive either intravenous ferrous sucrose (200mg/24hours for two consecutive days) or intravenous placebo, in addition to standard iron therapy. Clinical and laboratory data were obtained at 1, 2, and 6weeks. Main outcome measures Haemoglobin and haematocrit at 1, 2, and 6weeks. Other haematological and clinical parameters, psychological status, and adverse side effects were also evaluated. Results Haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points. At 6weeks, haemoglobin level (mean +/- SD) was 12.2 +/- 1.0 versus 12.2 +/- 0.9g/dl, with a mean difference of -0.03 (95%CI -0.6 to 0.6), in the placebo and in the intravenous iron groups, respectively. No differences were found between clinical symptoms of anaemia, psychological status, and adverse side effects between groups. Conclusions Intravenous iron added to oral iron therapy did not show significant benefits over placebo, neither in haemoglobin rise nor in symptoms or adverse side effects.