Actively Recruiting
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-06-10
300
Participants Needed
8
Research Sites
219 weeks
Total Duration
On this page
Sponsors
W
Women and Infants Hospital of Rhode Island
Lead Sponsor
H
Hasbro Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between the ages of 18-45
- Singleton gestation
- Iron-deficiency anemia with serum ferritin less than 30 ng/mL and hemoglobin less than 11 g/dL
- Between 13 and 30 weeks of pregnancy
- Plan to deliver at a participating hospital
You will not qualify if you...
- Anemia not caused by iron deficiency such as thalassemia, sickle cell disease, B12 or folate deficiency, or hypersplenism
- Conditions affecting iron absorption like malabsorptive syndrome, inflammatory bowel disease, or gastric bypass
- Sensitivity to oral or intravenous iron
- Multiple pregnancies (twins or more)
- Unable or unwilling to provide informed consent
- Unable to communicate with the study team even with an interpreter
- Planning to deliver at a hospital not affiliated with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35401
Actively Recruiting
2
GNP Research at Heme-on-Call
Miami, Florida, United States, 33143
Actively Recruiting
3
Michigan University Medical Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Washington University Medical Center
St Louis, Missouri, United States, 65105
Actively Recruiting
5
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, United States, 97239
Actively Recruiting
6
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
7
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
8
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
C
Crystal Ware, BSN, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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