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Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
NCT05462704 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ferric derisomaltose
- DRUG Ferrous sulfate
Study Locations (8)
Rhode Island
- Hasbro Children's Hospital — Providence
- Women & Infants Hospital of Rhode Island — Providence
Alabama
- University of Alabama Medical Center — Birmingham
Florida
- GNP Research at Heme-on-Call — Miami
Michigan
- Michigan University Medical Center — Ann Arbor
Missouri
- Washington University Medical Center — St Louis
Oregon
- Oregon Health and Sciences Uiversity Medical Center — Portland
Utah
- University of Utah Hospital — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05462704
The ClinicalTrials.gov registry entry for NCT05462704 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 25 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions — of which Ferric derisomaltose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05462704 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Rhode Island, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05462704 about?
NCT05462704 is a clinical study titled "Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy". 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 mor...
What is the current status of trial NCT05462704?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-01-17. Estimated completion is 2027-03-31.
What conditions does trial NCT05462704 study?
This clinical trial studies the following conditions: Pregnancy, Iron Deficiency Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05462704?
The interventions under investigation include: Ferric derisomaltose (DRUG), Ferrous sulfate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05462704?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 25 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05462704 being conducted?
This trial has 8 study locations across Alabama, Florida, Michigan, Missouri, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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