Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial

Adeola M Awomolo; Amanda McWhirter; Lynn C Sadler; Lynn M Coppola; Meghan G Hill

doi:10.1016/j.ajogmf.2023.101064

Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial

Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20.

Authors

Adeola M Awomolo¹, Amanda McWhirter¹, Lynn C Sadler², Lynn M Coppola¹, Meghan G Hill³

Affiliations

¹ College of Medicine, University of Arizona, Tucson, AZ (Drs Awomolo, McWhirter, and Coppola).
² Te Whatu Ora - Health New Zealand, New Zealand (Dr Sadler).
³ Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Dr Hill). Electronic address: meghan.hill@auckland.ac.nz.

PMID: 37348816
DOI: 10.1016/j.ajogmf.2023.101064

Abstract

Background: Iron-deficiency anemia in pregnancy is highly prevalent and presents significant risk to patients. Initial treatment is often with oral medication. We hypothesized that intravenous ferumoxytol would result in superior treatment of anemia as compared to oral ferrous sulfate.

Objective: This study aimed to investigate whether 2 infusions of intravenous ferumoxytol are superior to the use of twice-daily oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.

Study design: A randomized controlled trial was performed in which participants with anemic (hemoglobin <11 g/dL and hematocrit <33%) were allocated to receive either 2 infusions of 510 mg of intravenous ferumoxytol approximately 7 days apart, or 325 mg oral ferrous sulfate twice daily from enrollment to the end of their pregnancy. Participants were randomized in a 1:1 ratio to each treatment. Our primary outcome was the change in maternal hemoglobin. Secondary outcomes included maternal iron indices, maternal safety, and maternal tolerability.

Results: There were 124 participants (N=62 per group). In the intravenous iron group, the mean change in hemoglobin was 1.86 g/dL (95% confidence interval, 1.57 g/dL-2.14 g/dL) and in the oral group was 0.79 g/dL (95% confidence interval, 0.42 g/dL-1.17 g/dL) (P<.0001). The median change in ferritin between groups was 64.5 (range, 31-364) vs 8 (range, -436 to +167) (P=.0001). The median change in iron between groups was also statistically significant with 47.5 ug/dL (range, -133 ug/dL to +664 ug/dL) in the intravenous group vs 8.5 ug/dL (range, -313 ug/dL to +437 ug/dL) in the oral iron group (P=.001).

Conclusion: Intravenous ferumoxytol was well tolerated, and it was associated with statistically significant increases in maternal hemoglobin, hematocrit, iron, and ferritin compared to oral ferrous sulfate.

Trial registration: ClinicalTrials.gov NCT03657433.

Keywords: anemia; anemia in pregnancy; ferrous sulfate; intravenous ferumoxytol; iron-deficiency.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Anemia, Iron-Deficiency* / diagnosis
Anemia, Iron-Deficiency* / drug therapy
Anemia, Iron-Deficiency* / epidemiology
Female
Ferritins / therapeutic use
Ferrosoferric Oxide* / adverse effects
Hemoglobins / analysis
Hemoglobins / metabolism
Hemoglobins / therapeutic use
Humans
Infusions, Intravenous
Iron / therapeutic use
Pregnancy
Treatment Outcome

Substances

Ferrosoferric Oxide
ferrous sulfate
Iron
Ferritins
Hemoglobins

Associated data

ClinicalTrials.gov/NCT03657433