Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Summary

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion. The goal of this clinical trial: * Correct IDA with fewer visits and less impact on the healthcare system * Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.

Timeline

Start

2022-06-06

Primary completion

2026-12-31

Completion

2027-02-28

Publications

• Background Pavord S, Daru J, Prasannan N, Robinson S, Stanworth S, Girling J; BSH Committee. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2020 Mar;188(6):819-830. doi: 10.1111/bjh.16221. Epub 2019 Oct 2. No abstract available.
• Background Wesstrom J. Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy. Arch Gynecol Obstet. 2020 May;301(5):1127-1131. doi: 10.1007/s00404-020-05509-2. Epub 2020 Apr 8.
• Background Congdon EL, Westerlund A, Algarin CR, Peirano PD, Gregas M, Lozoff B, Nelson CA. Iron deficiency in infancy is associated with altered neural correlates of recognition memory at 10 years. J Pediatr. 2012 Jun;160(6):1027-33. doi: 10.1016/j.jpeds.2011.12.011. Epub 2012 Jan 11.
• Background Pollock RF, Muduma G. A budget impact analysis of parenteral iron treatments for iron deficiency anemia in the UK: reduced resource utilization with iron isomaltoside 1000. Clinicoecon Outcomes Res. 2017 Aug 10;9:475-483. doi: 10.2147/CEOR.S139525. eCollection 2017.
• Background Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial. Vox Sang. 2017 Apr;112(3):219-228. doi: 10.1111/vox.12477. Epub 2017 Feb 15.
• Background Khalafallah AA, Dennis AE, Ogden K, Robertson I, Charlton RH, Bellette JM, Shady JL, Blesingk N, Ball M. Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy. BMJ Open. 2012 Oct 18;2(5):e000998. doi: 10.1136/bmjopen-2012-000998. Print 2012.
• Background Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed., American Psychiatric Association, 2013. doi.org.db29.linccweb.org/10.1176/ appi.
• Background Duley L, Uhm S, Oliver S; Preterm Birth Priority Setting Partnership Steering Group. Top 15 UK research priorities for preterm birth. Lancet. 2014 Jun 14;383(9934):2041-2042. doi: 10.1016/S0140-6736(14)60989-2. No abstract available.

Drugs

Indications