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

Phase 3

Completed

Brief 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 & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Ferumoxytol Injection [Feraheme]	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.
Oral iron	Ferrous Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Median Change in Hemoglobin Value Before and After Intervention	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 Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued Treatment	From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants With Serious Adverse Events Associated With Treatment	From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants Who Need Blood Transfusion Postpartum	From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Change in Short Form (SF-)36 General Health Symptom Score	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)
Change in Short Form (SF-)36 Physical Functioning Score	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).
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score	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).
Change in Short Form (SF-)36 Energy/Fatigue Score	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).

Locations (1): Stanford University School of Medicine/Lucile Packard Childrens Hospital
🇺🇸
Stanford, California, United States
Stanford University School of Medicine/Lucile Packard Childrens Hospital
🇺🇸Stanford, California, United States