Testing equivalence of two doses of intravenous iron to treat iron deficiency in pregnancy: A randomised controlled trial

• DOI: 10.1111/1471-0528.17288
• Publication Date: 2022-09-01T10:59:28Z
• Authors: Bernd Froessler; Klaus Oliver Schu...; Peter Palm; Richard Church; Natalie Aboustate; Thu‐Lan Kelly; Gus A. Dekker; Nicolette A. Hodyl
• Keywords: Clinical endpoint

To test the equivalence of two doses intravenous iron (ferric carboxymaltose) in pregnancy.Parallel, two-arm randomised controlled trial with an margin 5%.Single centre Australia.278 pregnant women deficiency.Participants received either 500 mg (n = 152) or 1000 126) ferric carboxymaltose second third trimester.The proportion participants requiring additional (500 mg) to achieve and maintain ferritin >30 microg/L (diagnostic threshold for deficiency) at 4 weeks post-infusion, 6 weeks, 3-, 6- 12-months postpartum. Secondary endpoints included repeat infusion rate, status, birth safety outcomes.The were not equivalent within a 5% any time point. At post infusion, 26/73 (36%) required 500-mg group compared 5/67 (8%) 1000-mg group: difference proportions, 0.283 (95% confidence interval [CI] 0.177-0.389). Overall, arm twice rate (0.81 [SD 0.824] versus 0.40 0.69], ratio 2.05, 95% CI 1.45-2.91).Administration pregnancy maintains stores reduces need infusions. A 500- dose requires ongoing monitoring ensure adequate are reached sustained.