Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

Phase 3 Completed 124 enrolled University of Arizona AMAG Pharmaceuticals, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.

Timeline

Start: 2018-12-17
Primary completion: 2021-08-27
Completion: 2022-04-01

Outcome

Met primary endpoint

paper 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 PMID 37348816 ↗

paper (P<.0001). PMID 37348816 ↗

Publications

Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20.
Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferumoxytol	Diagnostic / imaging agent	510 mg	Intravenous