NCT03657433

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

Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy. 140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy. Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.

Conditions

• Iron Deficiency Anemia of Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ferrous sulfate 325mg	Oral tablets supplied for home use
DRUG	Ferumoxytol	Ferumoxytol will be administered in two infusions, one week apart

Timeline

• Start date: 2018-12-17
• Primary completion: 2021-08-27
• Completion: 2022-04-01
• First posted: 2018-09-05
• Last updated: 2022-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study