Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Dextrans; Iron-Dextran Complex

Criteria

Inclusion Criteria:

• Delivery at our institution

• Hemoglobin below 9 g/dl in postpartum day 1

• Singleton gestation

Exclusion Criteria:

• Diagnosis of malabsorptive disorder or history of gastric bypass procedure

• Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)

• Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure

• Patient has received blood transfusion or there is a plan to transfuse

• Lactose intolerance