Early Antenatal Support for Iron Deficiency Anemia

Study Overview
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Brief Summary
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This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Detailed Description
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Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

Official Title
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Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy

Conditions
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Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy

Intervention / Treatment
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* Drug: Ferumoxytol
* Drug: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton gestation Gestational age <24 weeks Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by: Hb<11.0 Ferritin<30 and/or total iron saturation <20 Exclusion Criteria: Sickle cell Disease (NOT sickle cell trait) Evidence of acute anemia requiring transfusion or IV iron therapy Major congenital or chromosomal anomaly Previous use of IV iron in this pregnancy Severe cardiac, renal, or liver disease Autoimmune disease (ie Systemic Lupus Erythematosus (SLE) Allergy or contraindication to either study drug History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Oral Iron<br>325mg oral iron (ferrous sulfate) twice daily | Drug: Ferrous Sulfate<br>* 325mg oral twice daily<br>|
| Experimental: Intravenous Iron<br>510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose. | Drug: Ferumoxytol<br>* 510mg infusion x 2 doses 3-8 days apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin | Change in hemoglboin at day 90 following treatment initiation | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia resolution | Percent of participants in each group with Hb>=11.0 at day 90 | 90 days | 
| Anemia at Delivery | Percent of participants in each group with Hb>=11.0 at delivery | 9 months | 
| Need for additional therapy | Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks | 9 months | 
| Quality of life scale | Linear Analogue Scale Assessment | 30, 60, 90 days | 
| Adherence | adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts | 90 days | 
| Need for post partum transfusion | Incidence of transfusion after delivery/post partum | 9 months | 
| Neonatal outcomes: cord blood iron indices | Hb, ferritin, total iron saturation | 9 months | 
| Neonatal outcomes: birth weight | birth weight (grams) | 9 months | 
| Neonatal outcomes gestational age of delivery (weeks) | gestational age of delivery (weeks) | 9 months |