Data from: Intravenous ferumoxytol versus oral ferrous sulfate for iron deficiency anemia in pregnancy: A randomized controlled trial

The objective of this study was too evaluate the comparative effectiveness
of intravenous (IV) ferumoxytol compared with oral ferrous sulfate for
increasing hemoglobin levels in the treatment of iron deficiency anemia
(IDA) in pregnancy. We conducted an open-label randomized controlled trial
to compare oral ferrous sulfate with IV ferumoxytol for the treatment of
IDA in pregnancy. Pregnant women with IDA (ferritin less than 30 ng/dL or
transferrin saturation less than 20 % and hemoglobin less than 11 g/dL) at
24–34 weeks of gestation were eligible; patients with hereditary anemias
or malabsorptive disorders were excluded. Patients were computer block
randomized to IV ferumoxytol (510 mg for hemoglobin 9.0–10.9 g/dL or 1,020
mg for hemoglobin 7.0–8.9 g/dL) or oral ferrous sulfate every other day
(325 mg for hemoglobin 9.0–10.9 g/dL or 650 mg for hemoglobin 7.0–8.9
g/dL). The primary outcome was the change in hemoglobin from treatment
initiation to week 4 postinitiation. We estimated that 80 patients were
needed, assuming an effect size of 1.0 g/dL, 90 % power, 5 % type I error
rate, and 20 % drop-out rate. Secondary outcomes included change in
hemoglobin by 8 weeks, anemia resolution, and postpartum hemoglobin.
Intention-to-treat analyses were conducted using Wilcoxon rank sum and
Fisher exact tests. Of the 80 randomized patients, 40 were assigned to
oral ferrous sulfate and 40 to IV ferumoxytol. Treatment with IV
ferumoxytol resulted in a greater change in hemoglobin at 4 weeks than
oral ferrous sulfate (median [Q1–Q3] 1.10 g/dL [0.70–1.70] vs 0.40 g/dL
[20.10 to 0.80], P < 0.001). Treatment with IV ferumoxytol also
resulted in a larger hemoglobin increase at 8 weeks (median [Q1–Q3] 1.80
g/dL [1.20–2.10] vs 0.70 g/dL [0.20–1.20], P < 0.001), resolution
of anemia (37/ 40 [92.5 %] vs 26/40 [65.0 %], P = 0.005), and higher
postpartum hemoglobin (median [Q1–Q3] 10.25 g/dL [9.28– 10.90] vs 9.65
[8.85–10.05]). Treatment of IDA during pregnancy with IV ferumoxytol
improved hemoglobin at delivery and reduced the prevalence of anemia to a
greater extent than oral ferrous sulfate.