Background and objectives: To explore if intravenous iron isomaltoside (Monofer®) leads to a better relief of fatigue than current treatment practice with oral iron in women suffering from severe fatigue after postpartum hemorrhage. Materials and methods: This is a subanalysis of a single-center, open-label, randomized controlled trial conducted in women suffering from postpartum hemorrhage. Participants were randomized 1:1 to 1200 mg iron isomaltoside or current treatment practice with oral iron. We measured fatigue by the Multidimensional Fatigue Inventory (MFI) and Edinburgh Postnatal Depression Scale, and determined hematological parameters. The subanalysis includes all participants with a high fatigue score (MFI physical fatigue score >15) at inclusion. The primary endpoint was aggregated change in physical fatigue score from inclusion to 12 weeks postpartum with a predefined minimum clinically relevant difference of 1.8. The trial is registered at ClinicalTrials.gov (identifier: NCT01895218). Results: A total of 85 women had a high fatigue score at inclusion. The aggregated change in physical fatigue score was -2.3 (confidence interval 95%: -3.3; -1.3) (p < .0001) in favor of iron isomaltoside. Significant differences in other fatigue and depression scores and hematological parameters were observed and all in favor of iron isomaltoside. There were no differences in side effects between the groups. Conclusions: In women suffering from severe fatigue after postpartum hemorrhage, a single dose of iron isomaltoside is associated with a statistically significant and clinically relevant reduction in aggregated physical fatigue within 12 weeks after delivery, when compared to current treatment practice with oral iron and with a similar safety profile.
Trial registration: ClinicalTrials.gov NCT01895218 NCT01628770.
Keywords: Anemia; intravenous iron; iron deficiency; postpartum depression; postpartum hemorrhage; ferric derisomaltose.