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

Study acronym: IVIDA2
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 746 to 300v6 Show 6 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints revised (25)
    • Study sites revised (8)
    • Collaborators: 3 to 7
    • Study description shortened, about 2 words
  2. Study sites: 4 to 8
    • Study completion date: Mar 30, 2027 to Mar 31, 2027
    v5
  3. Primary completion date: Jul 31, 2026 to Mar 30, 2027
    • Study completion date: Apr 30, 2027 to Mar 30, 2027
    • Eligibility criteria revised
    • Study description revised
    v4
  4. Site details revised at 3 of 4 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2022 to Jan 17, 2023
    • Site details revised at 4 of 4 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05462704
Lead Sponsor Women and Infants Hospital of Rhode Island
Collaborators: Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
Conditions
(from sponsor)		 Iron Deficiency Anemia, Pregnancy
Related terms Anemia, Iron-Deficiency
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov