Efficacy of Single-Dose Intravenous Ferric Derisomaltose for Iron Deficiency Anemia in Pregnancy

Iron deficiency anemia (IDA) is prevalent in pregnancy, yet oral iron therapies are associated with poor adherence and many intravenous (IV) iron formulations require multiple doses for treatment. Ferric derisomaltose (FDI) is a newer IV iron formulation that is safe and efficacious in non-pregnant individuals, yet pregnancy data is lacking. We evaluated the safety, efficacy, and maternal and neonatal outcomes associated with a single 1000 mg IV dose of FDI in pregnant individuals with IDA. We conducted a prospective, single-arm interventional trial of FDI administered in the second or third trimester of pregnancy from January 2024 to July 2025. The primary outcome was efficacy (hemoglobin increase of ≥ 1 g/dL). Secondary outcomes included safety, other hematologic parameters, patient-reported quality of life, and maternal and neonatal outcomes. Among 78 participants enrolled, 75 received FDI. From baseline to delivery, mean hemoglobin increased by 1.3 g/dL, with significant improvements (p < 0.001) in ferritin and transferrin saturation through 6 weeks postpartum. Patient-reported fatigue scores improved (p < 0.001), as did Edinburgh Postnatal Depression Scale scores (p = 0.003). The mean FDI infusion time was 24 min. Cord blood ferritin and hemoglobin values suggested enhanced neonatal iron status. No major infusion reactions or hospitalizations occurred. Minor infusion-related symptoms were uncommon and self-limited: chest tightness (6.7%), flushing (5.3%), mild shortness of breath (4%), urticaria (2.7%), rash (1.3%). Two patients (2.6%) did not complete the infusion due to reaction. These findings support single-dose IV FDI as a safe and effective option for late-pregnancy IDA, meriting further evaluation in larger controlled trials.