NCT05047211

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.

Conditions

• Anemia, Iron Deficiency
• Delivery Complication

Interventions

Type	Name	Description
DRUG	Ferrous sulfate	one tablet 325 milligrams three times a day
DRUG	Iron dextran	1000 mg intravenous infusion

Timeline

• Start date: 2021-10-07
• Primary completion: 2023-03-15
• Completion: 2023-04-15
• First posted: 2021-09-17
• Last updated: 2023-08-29
• Results posted: 2023-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study