Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Iron Deficiency Anemia, Pregnancy
In brief
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.
Key facts
- Study ID
- NCT05462704
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 300
- Starts
- 2023-01-17
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2025-06-10
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama Medical Center — Birmingham, Alabama, United States (enrolling)
- GNP Research at Heme-on-Call — Miami, Florida, United States (enrolling)
- Michigan University Medical Center — Ann Arbor, Michigan, United States (enrolling)
- Washington University Medical Center — St Louis, Missouri, United States (enrolling)
- Oregon Health and Sciences Uiversity Medical Center — Portland, Oregon, United States (enrolling)
- Hasbro Children's Hospital — Providence, Rhode Island, United States (enrolling)
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (enrolling)
- University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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