Intravenous ferric derisomaltose versus oral iron for iron deficient
pregnant women: a randomised controlled trial
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.