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Completed

NCT Number: NCT04253626

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

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.

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Key information

Conditions

Pregnancy Related Anemia Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University School of Medicine/Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferumoxytol Injection [Feraheme]

Drug

510mg intravenous ferumoxytol

Ferrous Sulfate

Drug

325mg oral ferrous sulfate

Primary outcomes

  1. Median Change in Hemoglobin Value Before and After Intervention

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

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

Secondary outcomes

  1. Number of Participants Who Discontinued Treatment

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

  2. 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)

  3. Number of Participants Who Need Blood Transfusion Postpartum

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

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

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

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

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

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

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

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

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

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

  7. Change in Short Form (SF-)36 Energy/Fatigue Score

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

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

Other outcomes

  1. Median Change in Hemoglobin Value Before and After Intervention by Sex

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

    NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention

  2. Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity

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

    NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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