Phase 3
N=80
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Pregnancy Related · Anemia, Iron Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT04253626 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Median Change in Hemoglobin Value Before and After Intervention — 10.95; 11.45 g/dL — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferumoxytol Injection [Feraheme] (Drug); Ferrous Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Hemoglobin Value Before and After Intervention |
10.95; 11.45 | < 0.001 sig |
| SECONDARY Number of Participants Who Discontinued Treatment |
6; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events Associated With Treatment |
0; 0 | — |
| SECONDARY Number of Participants Who Need Blood Transfusion Postpartum |
3; 0 | — |
| SECONDARY Change in Short Form (SF-)36 General Health Symptom Score |
63; 63; 0; 0 | 0.88 |
| SECONDARY Change in Short Form (SF-)36 Physical Functioning Score |
70; 70; -10; 0 | 0.27 |
| SECONDARY Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score |
38; 50; 0; 0 | 0.72 |
| SECONDARY Change in Short Form (SF-)36 Energy/Fatigue Score |
50; 40; 0; 10 | 0.009 sig |
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 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 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, 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
Data sourced from ClinicalTrials.gov (NCT04253626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.