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Testing equivalence of two doses of intravenous iron to treat iron deficiency in pregnancy: A randomised controlled trial
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  • Bernd Froessler,
  • Klaus Schubert,
  • Peter Palm,
  • Richard Church,
  • Natalie Aboustate,
  • Thu-Lan Kelly,
  • Gus Dekker,
  • Nicolette Hodyl
Bernd Froessler
Northern Adelaide Local Health Network

Corresponding Author:bernd.froessler@sa.gov.au

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Klaus Schubert
Adelaide Medical School Discipline of Psychiatry
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Peter Palm
Northern Adelaide Local Health Network
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Richard Church
Northern Adelaide Local Health Network
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Natalie Aboustate
Robinson Research Institute
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Thu-Lan Kelly
University of South Australia Clinical & Health Sciences Academic Unit
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Gus Dekker
Northern Adelaide Local Health Network
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Nicolette Hodyl
Hunter Medical Research Institute
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Abstract

Objective To test 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 1000mg (n=126) of intravenous ferric carboxymaltose in the second or third trimester. Main outcome measures The proportion of participants requiring additional intravenous iron (500mg) to achieve and maintain ferritin >30ug/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 timepoint. 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 (0.177, 0.389)). Overall, participants in the 500 mg arm received twice the repeat infusion rate (0.81 (SD= 0.824 vs 0.40 (SD= 0.69), rate ratio 2.05, 95% CI (1.45, 2.91)). Conclusions Administration of 1000mg 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.
22 Jun 2022Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
27 Jun 2022Submission Checks Completed
27 Jun 2022Assigned to Editor
27 Jun 2022Reviewer(s) Assigned
07 Jul 2022Review(s) Completed, Editorial Evaluation Pending
22 Jul 2022Editorial Decision: Revise Major
12 Aug 20221st Revision Received
19 Aug 2022Submission Checks Completed
19 Aug 2022Assigned to Editor
19 Aug 2022Review(s) Completed, Editorial Evaluation Pending
29 Aug 2022Editorial Decision: Accept
14 Sep 2022Published in BJOG: An International Journal of Obstetrics & Gynaecology. 10.1111/1471-0528.17288