drugset / Trial / NCT05047211

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

NCT05047211

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-10-07
Primary completion
2023-03-15
Completion
2023-04-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral
Subject Iron dextran Unknown 1000 mg Intravenous