Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia (IVIRONMAN)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Anemia, Iron Deficiency; Delivery Complication

Treatments: Drug: Ferrous sulfate; Drug: Iron dextran

Study type: Interventional

Funder types: Other

Identifiers

NCT05047211

21-0127

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Oral Iron group

Active Comparator group

Description:

Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous 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.

Treatment:

Drug: Ferrous sulfate

IV Iron group

Experimental group

Description:

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. Oral placebo will be given by mouth for a total of 6 weeks TID.

Treatment:

Drug: Iron dextran