Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: arandomized controlled trial

Background and ObjectivesTo evaluate the clinical efficacy of a single-dose intravenous infusion of iron isomaltoside compared with current treatment practice with oral iron measured by physical fatigue in women after postpartum haemorrhage. Materials and MethodsSingle-centre, open-label, randomized controlled trial. Participants received intravenous iron (n=97) or oral iron (n=99), and completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and haematological and iron parameters were measured. Primary outcome was the aggregated change in physical fatigue score from baseline to 12weeks postpartum. ResultsThe difference in physical fatigue score was -097 (95% CI: -165; -028, P=0006) in favour of intravenous iron, but did not meet the predefined difference of 18. Across visits, we found statistically significant differences in fatigue and depression scores, as well as in haematological and iron parameters, all in favour of intravenous iron. There were no serious adverse reactions. ConclusionA single dose of intravenous iron was associated with a statistically significant reduction in aggregated physical fatigue within 12weeks after postpartum haemorrhage compared to standard medical care with oral iron below the prespecified criteria of clinical superiority. As patient-reported outcomes improved significantly and intravenous iron resulted in a fast hematopoietic response without serious adverse reactions, intravenous iron may be a useful alternative after postpartum haemorrhage if oral iron is not absorbed or tolerated.