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Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

RecruitingPhase 3Ages 18 Years - 45 YearsFemaleWomen and Infants Hospital of Rhode Island
NCT05462704 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women between the ages of 18-45 * Singleton gestation * Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL) * At 13-30 weeks gestation * Plan to deliver at participating hospital Exclusion Criteria: * Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism. * Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron * Multiple gestation * Inability or unwillingness to provide informed consent * Inability to communicate with members of the study team, despite the presence of an interpreter * Planned delivery at a non-study affiliated hospital
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What it tests

  • Ferric derisomaltose
  • Ferrous sulfate
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Where

8 sites
University of Alabama Medical Center
Birmingham, United States
GNP Research at Heme-on-Call
Miami, United States
Michigan University Medical Center
Ann Arbor, United States
Washington University Medical Center
St Louis, United States
Oregon Health and Sciences Uiversity Medical Center
Portland, United States
Hasbro Children's Hospital
Providence, United States
Women & Infants Hospital of Rhode Island
Providence, United States
University of Utah Hospital
Salt Lake City, 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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