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

Autor: Froessler B; Department of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.; Discipline of Acute Care Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia., Schubert KO; Discipline of Psychiatry, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.; Northern Adelaide Mental Health Services, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia., Palm P; Department of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.; Discipline of Acute Care Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia., Church R; Department of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.; Discipline of Acute Care Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia., Aboustate N; Robinson Research Institute, North Adelaide, South Australia, Australia., Kelly TL; Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Clinical and Health Sciences, Adelaide, South Australia, Australia., Dekker GA; Department of Obstetrics and Gynaecology, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.; Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia., Hodyl NA; Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.; Hunter Medical Research Institute, Newcastle, New South Wales, Australia.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2023 Jan; Vol. 130 (1), pp. 15-23. Date of Electronic Publication: 2022 Sep 14.
DOI: 10.1111/1471-0528.17288
Abstrakt: Objective: To test the equivalence of two doses of intravenous iron (ferric carboxymaltose) in pregnancy.
Design: Parallel, two-arm equivalence randomised controlled trial with an equivalence margin of 5%.
Setting: Single centre in Australia.
Population: 278 pregnant women with iron deficiency.
Methods: Participants received either 500 mg (n = 152) or 1000 mg (n = 126) of intravenous ferric carboxymaltose in the second or third trimester.
Main Outcome Measures: The proportion of participants requiring additional intravenous iron (500 mg) to achieve and maintain ferritin >30 microg/L (diagnostic threshold for iron deficiency) at 4 weeks post-infusion, and at 6 weeks, and 3-, 6- and 12-months postpartum. Secondary endpoints included repeat infusion rate, iron status, birth and safety outcomes.
Results: The two doses were not equivalent within a 5% margin at any time point. At 4 weeks post infusion, 26/73 (36%) participants required a repeat infusion in the 500-mg group compared with 5/67 (8%) in the 1000-mg group: difference in proportions, 0.283 (95% confidence interval [CI] 0.177-0.389). Overall, participants in the 500-mg arm received twice the repeat infusion rate (0.81 [SD = 0.824] versus 0.40 [SD = 0.69], rate ratio 2.05, 95% CI 1.45-2.91).
Conclusions: Administration of 1000 mg ferric carboxymaltose in pregnancy maintains iron stores and reduces the need for repeat infusions. A 500- mg dose requires ongoing monitoring to ensure adequate iron stores are reached and sustained.
(© 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
Externí odkaz: