Double-blind Randomized Study Comparing Intravenous and Oral Iron Treatments for Iron-Deficiency Anemia in Pregnant Women

What this Trial Is About

This research aims to evaluate intravenous IV iron compared to oral iron in pregnant women with iron-deficiency anemia IDA between 13 to 30 weeks of pregnancy. The study focuses on women with low hemoglobin and ferritin levels, examining whether IV iron can reduce severe maternal anemia at delivery and improve the childs brain development. IDA during pregnancy is common and linked to negative outcomes such as blood transfusions, preterm birth, and low birth weight, with current oral treatments often causing side effects that reduce adherence. Participants are randomly assigned to receive either a single IV infusion of 1000 mg ferric derisomaltose or an IV placebo infusion with daily oral ferrous sulfate tablets until delivery. The trial is double-blind and placebo-controlled, conducted across multiple centers in the U.S. The study compares the safety, effectiveness, and cost of these two iron delivery methods in pregnant women with IDA. During the study, participants will be monitored through blood tests measuring hemoglobin, ferritin, and other maternal and neonatal health indicators around delivery and postpartum. Researchers will also assess maternal quality of life, depression scores, and infant neurodevelopment at 6 and 36 months. Safety events, delivery outcomes, and infant health will be closely tracked throughout the trial, which is expected to last until 2027.

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