Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

Study Overview
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Brief Summary
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This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.

Detailed Description
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This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy. 140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy. Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.

Official Title
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Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial

Conditions
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Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
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* Dietary Supplement: Ferrous sulfate 325mg
* Drug: Ferumoxytol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age >/= 18 Singleton gestation >/=20 weeks gestation, <37 weeks gestation Hemoglobin <11g/dL and/or hematocrit <33% Able to read/speak English or Spanish Exclusion Criteria: Maternal age <18 Multiple gestation <20 weeks gestation, </= 37 weeks gestation Hemoglobin >/=11g/dL and/or hematocrit >/=33% Unable to read or speak English or Spanish Incarcerated patients

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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No

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 Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferumoxyltol<br>Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. | Drug: Ferumoxytol<br>* Ferumoxytol will be administered in two infusions, one week apart<br>|
| Active Comparator: Ferrous Sulfate<br>Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. | Dietary Supplement: Ferrous sulfate 325mg<br>* Oral tablets supplied for home use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin | We will assess the increase in maternal hemoglobin during the study timeframe | 1 day - 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other laboratory values | Including hematocrit, serum iron, transferrin saturation, ferritin | 1 day - 22 weeks | 
| Blood loss at delivery | Estimated or quantified blood loss at delivery | 1 day - 22 weeks | 
| Hemoglobin change after delivery | Measured change in hemoglobin after delivery | 1 day - 22 weeks | 
| Blood transfusion | Whether the mother requires a blood transfusion | 1 day - 22 weeks | 
| Iron infusion | Whether the mother requires additional iron infusions | 1 day - 22 weeks | 
| Concentration of substances in cord blood (iron studies) | Cord blood indices for iron, transferrin saturation and ferritin | 1 day - 22 weeks | 
| Preterm delivery | Whether the delivery occurs at less than 37 weeks of gestation | 1 day - 22 weeks | 
| Indication for delivery | Indication for delivery if not spontaneous | 1 day - 22 weeks | 
| Birth weight | Neonatal weight immediately after delivery | 1 day - 22 weeks |