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Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Sponsor: Women and Infants Hospital of Rhode Island
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.
Official title: Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-01-17
Completion Date
2027-03-31
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
Ferric derisomaltose
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
Ferrous sulfate
325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.
Locations (8)
University of Alabama Medical Center
Birmingham, Alabama, United States
GNP Research at Heme-on-Call
Miami, Florida, United States
Michigan University Medical Center
Ann Arbor, Michigan, United States
Washington University Medical Center
St Louis, Missouri, United States
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Utah Hospital
Salt Lake City, Utah, United States