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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Ferric Compounds; Ferrosoferric Oxide; Iron

Criteria

Inclusion Criteria:

1. Women 18 years old and above receiving prenatal care at Stanford/LPCH OB clinic

2. Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20%

3. Between 24-34 weeks' pregnancy

4. Singleton pregnancy

5. Viable Pregnancy

6. Hemodynamically stable

Exclusion Criteria:

1. Patients unable to give informed consent

2. Known allergy/hypersensitivity to IV iron

3. Inflammatory Bowel Disease or history of gastric bypass surgery

4. Chronic Kidney Disease

5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia

6. Folate/Vitamin B12 deficiency

7. Known malignancy

8. History of multiple medication allergies (> 2 allergies)

9. Hemoglobin above 12 or less than 7 g/dL

10. Patients with complex past medical histories which may include history of multiple medication allergies, connective tissue disorder, etc.