Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Study Overview
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Brief Summary
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Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Official Title
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Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Conditions
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Pregnancy Related, Anemia, Iron Deficiency

Intervention / Treatment
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* Drug: Ferumoxytol Injection [Feraheme]
* Drug: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women 18 years old and above Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20% Between 24-34 weeks' pregnancy Singleton pregnancy Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH Hemodynamically stable Exclusion Criteria: Patients unable to give informed consent Known allergy/hypersensitivity to IV iron Inflammatory Bowel Disease or history of gastric bypass surgery Dialysis-dependent Chronic Kidney Disease/ ESRD Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia Folate/Vitamin B12 deficiency Known malignancy Medication allergy to Tylenol (acetaminophen) Hemoglobin above 12 or less than 7 g/dL Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc. Diagnosis of placenta previa

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous iron<br>Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes. | Drug: Ferumoxytol Injection [Feraheme]<br>* 510mg intravenous ferumoxytol<br>|
| Active Comparator: Oral iron<br>Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin < 9. | Drug: Ferrous Sulfate<br>* 325mg oral ferrous sulfate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hemoglobin value before and after intervention | Hemoglobin is measured as g/dL at enrollment and after the study intervention | From the date of randomization to four weeks after the intervention |