Single‐dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial

Abstract

Background and Objectives To 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 12 weeks postpartum.Results The difference in physical fatigue score was -0Á97 (95% CI: -1Á65; -0Á28, P = 0Á006) in favour of intravenous iron, but did not meet the predefined difference of 1Á8. 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.Conclusion A single dose of intravenous iron was associated with a statistically significant reduction in aggregated physical fatigue within 12 weeks 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.

Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage

“…This finding is consistent with the main trial [18]. In the main trial, there was an estimated difference of À0.97 in physical fatigue score between the treatment groups which was less than the predefined minimum clinically relevant difference of 1.8 required for claiming superiority [18]. However, in this subanalysis, the estimated difference of À2.3 reached the predefined target of 1.8, and superiority was confirmed for iron isomaltoside compared with current treatment practice with oral iron in women suffering from severe fatigue after PPH.…”

“…The difference estimate between the two treatments groups was À2.3 (p < .0001), showing that treatment with iron isomaltoside lead to a significantly higher decrease in physical fatigue when compared to current treatment practice with oral iron. This finding is consistent with the main trial [18]. In the main trial, there was an estimated difference of À0.97 in physical fatigue score between the treatment groups which was less than the predefined minimum clinically relevant difference of 1.8 required for claiming superiority [18].…”

“…Out of the 200 women enrolled in the main trial [18], 85 women had a baseline physical fatigue score >15. These participants in the main trial were randomized 1:1 to the iron isomaltoside group (41 participants) or oral iron (44 participants).…”

“…Iron isomaltoside (Monofer V R , Pharmacosmos, Holbaek, Denmark) is one of the newer IV iron formulations available. Clinical efficacy and safety data is available for iron isomaltoside administered to patients with iron deficiency anemia requiring iron therapy [8][9][10][11][12][13][14][15][16], nonanemic patients undergoing cardiac surgery [17], and women with PPH [18,19]. In a previous trial including 196 women with PPH, a single dose of iron isomaltoside was associated with a statistically significant reduction in aggregated physical fatigue within 12 weeks compared to current treatment practice with oral iron, however below the prespecified criteria of clinical superiority [18].…”

“…We here present data from a subpopulation of women with PPH from this previously reported trial [18]. The objective was to compare the efficacy and safety of iron isomaltoside with current treatment practice with oral iron in women with PPH and who suffered from severe fatigue measured by the Multidimensional Fatigue Inventory (MFI) within 48 hours after delivery.…”