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

Rebecka Hansen, Veronika Markova Sommer, Anja Pinborg, Lone Krebs, Lars Lykke Thomsen, Torben Moos, Charlotte Holm

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Abstract

Purpose: To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14–21 weeks pregnant with persistent iron deficiency (ferritin < 30 µg/L). Methods: In a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000 mg IV iron (single-dose) or 100 mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary endpoint was the proportion of non-anaemic (haemoglobin [Hb] ≥ 11 g/dL) women throughout follow-up. Other outcomes included changes in haematological parameters, patient-reported fatigue, and quality of life (QoL). Safety was assessed by recording adverse events. Results: From July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10–0.25]; p < 0.001). The mean Hb increase was significantly greater with IV iron versus oral iron at Weeks 6 (0.4 versus − 0.2 g/dL; p < 0.001), 12 (0.5 versus 0.1 g/dL; p < 0.001), and 18 (0.8 versus 0.5 g/dL; p = 0.01). Improvements in fatigue and QoL were greater with IV iron versus oral iron at Weeks 3 and 6. The incidence of treatment-related adverse events was comparable between treatment groups. Conclusion: IV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL. Clinical trial registration: European Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017). The trial protocol has been published: https://dx.doi.org/10.1186%2Fs13063-020-04637-z.

Original languageEnglish
JournalArchives of Gynecology and Obstetrics
Volume308
Issue number4
Pages (from-to)1165-1173
Number of pages9
ISSN0932-0067
DOIs
Publication statusPublished - Oct 2023

Bibliographical note

Funding:
The trial was sponsored and fully funded by Pharmacosmos A/S, Holbæk, Denmark.

Keywords

  • Anaemia
  • Intravenous iron
  • Iron deficiency
  • Pregnancy

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