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Early Antenatal Support for Iron Deficiency Anemia

RecruitingPhase 4Ages 18 Years - 65 YearsFemaleThomas Jefferson University
NCT04278651 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Singleton gestation * 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: * Sickle cell Disease (NOT sickle cell trait) * 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
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What it tests

  • Ferumoxytol
  • Ferrous Sulfate
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Where

1 site
Thomas Jefferson University Hospital
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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