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

Phase

Condition

Anemia

Treatment

Ferumoxytol Injection [Feraheme]

Ferrous Sulfate

Clinical Study ID

NCT04253626

54788

K12HD103084

Ages > 18
Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

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, alphathalassemia
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 multiplemedication allergies (greater than 2 allergies), connective tissue disorder, etc.
Diagnosis of placenta previa

Study Design