Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2021-09-29
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Iron
325mg oral iron (ferrous sulfate) twice daily
Ferrous Sulfate
325mg oral twice daily
Intravenous Iron
510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.
Ferumoxytol
510mg infusion x 2 doses 3-8 days apart
Interventions
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Ferumoxytol
510mg infusion x 2 doses 3-8 days apart
Ferrous Sulfate
325mg oral twice daily
Eligibility Criteria
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Inclusion Criteria
* Gestational age \<24 weeks
* Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia
Iron deficiency anemia diagnosed (at any point in patient history) by:
* Hb\<11.0
* Ferritin\<30 and/or total iron saturation \<20
Exclusion Criteria
* Evidence of acute anemia requiring transfusion or IV iron therapy
* Major congenital or chromosomal anomaly
* Previous use of IV iron in this pregnancy
* Severe cardiac, renal, or liver disease
* Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
* Allergy or contraindication to either study drug
* History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
18 Years
65 Years
FEMALE
No
Sponsors
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Auerbach Hematology and Oncology
UNKNOWN
Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19G.929
Identifier Type: -
Identifier Source: org_study_id
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