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NCT05462704 · ClinicalTrials.gov registry record · Phase 3
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
A Phase 3 study of Pregnancy and Iron Deficiency Anemia, sponsored by Women and Infants Hospital of Rhode Island.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 8
- Study locations
NCT05462704 is a Phase 3 study of Pregnancy and Iron Deficiency Anemia that is actively recruiting participants, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 300 participants, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (66% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT05462704, a Phase 3 study of Pregnancy and Iron Deficiency Anemia, is actively recruiting participants, sponsored by Women and Infants Hospital of Rhode Island.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (66% lower). The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
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.
NCT05462704 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Rhode Island, Alabama, Florida.
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.
What interventions are being tested in trial NCT05462704?
The interventions under investigation include: Ferric derisomaltose (DRUG), Ferrous sulfate (DRUG).
Who is sponsoring clinical trial NCT05462704?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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