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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04253626
• Other study ID #: 54788
• Secondary ID: K12HD103084
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 21, 2021
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Pregnancy Related

Intervention

Drug:
• Ferumoxytol Injection [Feraheme]
510mg intravenous ferumoxytol
• Ferrous Sulfate
325mg oral ferrous sulfate

Locations

Country	Name	City	State
United States	Stanford University School of Medicine/Lucile Packard Childrens Hospital	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hemoglobin value before and after intervention	Hemoglobin is measured as g/dL at enrollment and after the study intervention	From the date of randomization to four weeks after the intervention