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

Completed · Phase 3

Conditions studied: Pregnancy Related, Anemia, Iron Deficiency

In brief

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.

Key facts

Study ID

NCT04253626

Run by

Stanford University

People needed

83

Starts

2021-01-21

Expected to finish

2024-07-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine/Lucile Packard Childrens Hospital — Stanford, California, United States

Full record on ClinicalTrials.gov

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