Data from: Intravenous ferumoxytol versus oral ferrous sulfate for iron deficiency anemia in pregnancy: A randomized controlled trial
Data files
Apr 22, 2026 version files 7.58 KB
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Deidentifed_Data4.11.26.csv
4.88 KB
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README.md
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Abstract
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.
Dataset DOI: 10.5061/dryad.k3j9kd5qd
Description of the data and file structure
This dataset contains the study arms and outcomes for the intention to treat analysis.
Data are shared in one .csv file called “Deidentifed_Data4.11.26.csv”. The file contains one row per participant. Missing lab values are indicated by "NA” --this means that this lab measurement was not collected for the participant at the given time point. Included variables:
- ID: De-identified participant ID
- arm: Study arm based on randomization (intention to treat)
- parity: Nulliparous (no previous births) or Multiparous (one or more previous births)
- screening_hgb: Hemoglobin (g/dL) at 24-28 weeks gestational age, before treatment initiation
- ferritin: Serum Ferritin (ng/mL) at 24-28 weeks gestational age
- tsat: Percent Transferrin Saturation at 24-28 weeks gestational age
- fourwk_hgb: Hemoglobin (g/dL) four weeks after treatment initiation
- eightwk_hgb: Hemoglobin (g/dL) eight weeks after treatment initiation. Many participants have "NA" for this value as they delivered before eight weeks after treatment initiation.
- hgb_admit: Hemoglobin (g/dL) at admission for delivery
- ga_deliv_wks: Gestational age at delivery in weeks, rounded down
Human subjects data
Participants provided written consent for their de-identified data to be shared. The consent form contained the following language:
"Future Use of Private Information and/or Specimens: Research using private information and/or specimens is an important way to try to understand human disease. You are being given this information because the investigators want to save private information and/or specimens for future research. Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified."
Data were de-identified by the research team by removing identifiers and generating a new study ID for each participant using a random sequence generator.