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

Stanford University

Status and phase: Completed; Phase 3

Conditions: Pregnancy Related; Anemia, Iron Deficiency

Treatments: Drug: Ferrous Sulfate; Drug: Ferumoxytol Injection [Feraheme]

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04253626

54788

K12HD103084 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pregnant women 18 years old and above
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. Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
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. Dialysis-dependent Chronic Kidney Disease/ ESRD
5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
6. Folate/Vitamin B12 deficiency
7. Known malignancy
8. Medication allergy to Tylenol (acetaminophen)
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 (greater than 2 allergies), connective tissue disorder, etc.
11. Diagnosis of placenta previa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intravenous iron

Experimental group

Description:

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.

Treatment:

Drug: Ferumoxytol Injection [Feraheme]

Oral iron

Active Comparator group

Description:

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.

Treatment:

Drug: Ferrous Sulfate