Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

Study Overview
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Brief Summary
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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: 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. 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.

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

Conditions
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Anemia, Iron Deficiency, Delivery Complication

Intervention / Treatment
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* Drug: Ferrous sulfate
* Drug: Iron dextran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Iron group<br>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. | Drug: Ferrous sulfate<br>* one tablet 325 milligrams three times a day<br>|
| Experimental: IV Iron group<br>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. | Drug: Iron dextran<br>* 1000 mg intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Level | hemoglobin in grams per deciliters | 6 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nausea or Vomiting | feeling sick to vomit or vomit | up to 6 weeks after delivery | 
| Myalgia | Generalized muscle pain | up to 6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, iron deficiency anemia, intravenous iron