Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy (NCT05462704)
Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).
Location: University of Alabama Medical Center — Birmingham, Alabama
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- University of Alabama Medical Center — Birmingham, Alabama
- GNP Research at Heme-on-Call — Miami, Florida
- Michigan University Medical Center — Ann Arbor, Michigan
- Washington University Medical Center — St Louis, Missouri
- Oregon Health and Sciences Uiversity Medical Center — Portland, Oregon
- Hasbro Children's Hospital — Providence, Rhode Island
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island
- University of Utah Hospital — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (401) 274-1122
Email: cware@wihri.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Iron Deficiency Anemia
- Effectiveness and Acceptability of LISEFEX® (Liposomal Iron With Vitamin C and Fiber) in People With Iron Deficiency Anemia. — Monterrey, Nuevo León
- Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient — Baltimore, Maryland
- A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects — Little Rock, Arkansas
Explore by condition: All Iron Deficiency Anemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.