NCT04278651

Early Antenatal Support for Iron Deficiency Anemia

Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Detailed description

Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

Conditions

• Pregnancy Related
• Anemia, Iron Deficiency
• Anemia of Pregnancy

Interventions

Type	Name	Description
DRUG	Ferumoxytol	510mg infusion x 2 doses 3-8 days apart
DRUG	Ferrous Sulfate	325mg oral twice daily

Timeline

• Start date: 2021-09-29
• Primary completion: 2026-08-30
• Completion: 2026-12-30
• First posted: 2020-02-20
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study