loading page

Impact of postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose or oral ferrous sulphate on maternal fatigue: a randomized clinical trial
  • +5
  • Lea BOMBAČ TAVČAR,
  • Hana HROBAT,
  • Lea GORNIK,
  • Marijana Vidmar Simic,
  • Polona PEČLIN,
  • Irena PRELOŽNIK ZUPAN,
  • Gorazd KAVŠEK,
  • Miha Lucovnik
Lea BOMBAČ TAVČAR
Univerza v Ljubljani Medicinska fakulteta

Corresponding Author:[email protected]

Author Profile
Hana HROBAT
Univerza v Ljubljani Medicinska fakulteta
Author Profile
Lea GORNIK
Univerza v Ljubljani Medicinska fakulteta
Author Profile
Marijana Vidmar Simic
Univerzitetni klinicni center Ljubljana
Author Profile
Polona PEČLIN
Univerzitetni klinicni center Ljubljana
Author Profile
Irena PRELOŽNIK ZUPAN
Univerza v Ljubljani Medicinska fakulteta
Author Profile
Gorazd KAVŠEK
Univerzitetni klinicni center Ljubljana
Author Profile
Miha Lucovnik
Univerza v Ljubljani Medicinska fakulteta
Author Profile

Abstract

Objective: To compare intravenous ferric carboxymaltose, intravenous ferric derisomaltose and oral ferrous sulphate for treatment of postpartum anemia. Design: Single-center, open-label, randomized trial. Setting: Tertiary perinatal center. Population: Three-hundred women with postpartum anemia (hemoglobin < 100 g/L within 48-hours postpartum) were included between September 2020 and March 2022. Methods: Women were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose or oral ferrous sulphate. Intravenous iron was given in one or two doses, while ferrous sulphate as two 80 mg tablets once daily. Main outcome measures: Primary outcome was maternal fatigue measured by Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin and transferrin saturation levels were analyzed as secondary outcomes. Kruskal-Wallis test was used for group comparison (p<0.05 significant). Results: MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 20-74) in the ferric carboxymaltose, median 34 (IQR 20-70) in the ferric derisomaltose, and median 36 (IQR 20-72) in the ferrous sulphate group; p=0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (119-150) vs 134 (113-157) vs 131 (125-137) g/L; p=0.008), ferritin (273 (198-377) vs 187 (155-246) vs 24 (17-37) µg/L; p<0.001) and transferrin saturation (34 (28–38) vs 30 (23–37) vs 24 (17-37) %; p<0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose and oral ferrous sulphate had similar impact on maternal fatigue at six weeks postpartum despite improved hematological laboratory parameters in the intravenous iron groups.