RecruitingPhase 3NCT05462704

Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

300 participants

Start Date

Jan 17, 2023

Study Type

INTERVENTIONAL

Conditions

Pregnancy Iron-Deficiency Anemia

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ferric derisomaltose and a drug called Ferrous sulfate for people with iron-deficiency anemia and pregnancy. The study is currently recruiting participants at 8 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric 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.

DRUGFerrous sulfate

325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.