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 morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.

NCT Number	NCT05462704
Lead Sponsor	Women and Infants Hospital of Rhode Island Collaborators: Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
Conditions	Iron Deficiency Anemia, Pregnancy
Enrollment	300 participants
Start Date	2023-01-17
Primary Completion	2027-03-30 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-10