loading page

Intravenous ferric derisomaltose versus oral iron for iron deficient pregnant women: a randomised controlled trial
  • +4
  • Rebecka Hansen,
  • Veronika Sommer,
  • Anja Pinborg,
  • Lone Krebs,
  • Lars Thomsen,
  • Torben Moos,
  • Charlotte Holm
Rebecka Hansen
Copenhagen University Hospital Hvidovre

Corresponding Author:[email protected]

Author Profile
Veronika Sommer
Copenhagen University Hospital Hvidovre
Author Profile
Anja Pinborg
Copenhagen University Hospital Rigshospitalet
Author Profile
Lone Krebs
Copenhagen University Hospital Hvidovre
Author Profile
Lars Thomsen
Pharmacosmos AS
Author Profile
Torben Moos
Aalborg University
Author Profile
Charlotte Holm
Copenhagen University Hospital Hvidovre
Author Profile


Objective:Compare the efficacy of intravenous ferric derisomaltose (FDI) with oral iron in pregnant women with persistent iron deficiency.
Design:Single-centre, open-labelled, randomised controlled trial.
Setting:Danish university hospital.
Population:Women 14–21 weeks pregnant with persistent iron deficiency (ferritin <30 µg/L).
Methods:Allocation to 1,000 mg intravenous FDI (single-dose) or 100 mg elemental oral iron daily (FA). Assessment of blood tests, patient reported outcomes (fatigue and quality of life) and adverse events throughout eighteen weeks’ follow-up.
Main_outcome_measures:Proportion of non-anaemic (haemoglobin ≥11 g/dL) women throughout follow-up (primary endpoint), assessed by Kaplan-Meier estimates compared between groups by risk difference analysis. Change in haematological markers and patient reported outcomes, assessed by restricted maximum likelihood estimates compared between groups by a repeated measures mixed model.
Results:From July 2017 through February 2020, 100 women were randomised to FDI and 101 to FA. In the FDI vs. FA group 89% vs. 88% were non-anaemic prior to inclusion. Throughout follow-up, 91% vs. 73% were non-anaemic in favor of FDI (18% difference, 95% CI 0.10–0.25, p<0.001). The haemoglobin least-squares mean increase was significantly greater in the FDI vs. FA group at week six (0.4 vs. -0.2 g/dL, p<0.001), twelve (0.5 vs. 0.1 g/dL, p<0.001) and eighteen (0.8 vs. 0.5 g/dL, p=0.01). Improvements in patient reported fatigue and psychological well-being were greater in the FDI group at weeks three and six. The incidence of treatment related adverse events was comparable across treatments.
Conclusions:FDI was superior for avoiding anaemia compared to oral treatment, and biochemical superiority was accompanied by improved fatigue and psychological well-being.
15 Oct 2021Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
15 Oct 2021Assigned to Editor
15 Oct 2021Submission Checks Completed
21 Oct 2021Reviewer(s) Assigned
07 Feb 2022Review(s) Completed, Editorial Evaluation Pending