Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Phase 3 Completed 83 enrolled Stanford University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Timeline

Start: 2021-01-21
Primary completion: 2024-07-01
Completion: 2024-07-01

Outcome

Met primary endpoint

paper Treatment with IV ferumoxytol resulted in a greater change in hemoglobin at 4 weeks than oral ferrous sulfate PMID 41860281 ↗

registry analysis (other test); Oral Iron vs Intravenous Iron; p < 0.001; Wilcoxon (Mann-Whitney); NCT04253626 ↗

Publications

Results Igbinosa II, Leonard SA, Iwekaogwu I, Sherwin EB, Berube C, Lyell DJ. Intravenous Ferumoxytol Compared With Oral Ferrous Sulfate for Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2026 May 1;147(5):745-753. doi: 10.1097/AOG.0000000000006245. Epub 2026 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ferrous Sulfate	Diagnostic / imaging agent	325 mg	Oral
Comparator	Ferrous Sulfate	Diagnostic / imaging agent	650 mg	Oral
Subject	Ferumoxytol	Diagnostic / imaging agent	510 mg	Intravenous
Subject	Ferumoxytol	Diagnostic / imaging agent	1020 mg	Intravenous