Impact of postpartum anemia treatment with intravenous ferric
carboxymaltose, intravenous ferric derisomaltose or oral ferrous
sulphate on maternal fatigue: a randomized clinical trial
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.