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

Stanford University83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Ferumoxytol Injection [Feraheme]DRUG

510mg intravenous ferumoxytol

Ferrous SulfateDRUG

325mg oral ferrous sulfate

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine/Lucile Packard Childrens Hospital

Stanford, California, United States

Outcomes

Primary Outcomes

Median Change in Hemoglobin Value Before and After Intervention

Hemoglobin is measured as g/dL at enrollment and after the study intervention

Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Secondary Outcomes

Number of Participants Who Discontinued Treatment

Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Number of Participants With Serious Adverse Events Associated With Treatment

Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Number of Participants Who Need Blood Transfusion Postpartum

Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

Change in Short Form (SF-)36 General Health Symptom Score

Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)

Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Change in Short Form (SF-)36 Physical Functioning Score

Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).

Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score

Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).

Data from ClinicalTrials.gov

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