Single-Dose IV Ferric Derisomaltose (1000mg given over 20 minutes) for the Treatment of Iron Deficiency Anemia in Pregnancy: A Prospective Interventional Clinical Trial (NCT05763043)
Authors: Shatzel Joseph J. , Lo Jamie O , Martens Kylee L , Padilla Thalia , Benson Ashley E , Rincon Monica 
Published: December 2024

Background: Iron deficiency is a significant and prevalent health condition impacting nearly half of pregnant individuals globally. It is the leading cause of chronic disability in women, contributing to fatigue, diminished concentration, and adverse maternal and fetal outcomes during pregnancy and postpartum. Despite its high prevalence, oral iron repletion strategies in pregnancy often have limited efficacy and significant side effects. Intravenous (IV) iron formulations are more effective in restoring iron levels and have been shown to be safe during pregnancy but most are typically resource-intensive, requiring multiple small doses or test doses. IV ferric derisomaltose (FDI), a single-dose, rapid infusion formulation, has the potential to reduce time and cost barriers. However, there are limited studies regarding its efficacy and safety in pregnant individuals. This study aims to evaluate the safety and efficacy of a single dose of 1,000 mg IV FDI administered over 20 minutes in pregnant individuals with iron deficiency anemia.

Methods: This prospective observational study began enrollment in March 2024 and will include 65 pregnant individuals with iron deficiency anemia and oral iron intolerance or advanced gestational age (&gt;28 weeks). Participants are recruited via prenatal visits at a single academic institution. Participants receive standard prenatal care plus two additional questionnaires and blood draws (one at time of iron infusion, one at time of delivery from the umbilical cord, and one at 6 weeks postpartum). Efficacy data will be collected through hematologic indices (Hgb, MCV, TSAT, ferritin) and quality of life scores (PROMIS Fatigue, Edinburgh Depression Scale, and FACIT-Fatigue). Safety measures include vital sign monitoring and symptom assessment during and after FDI administration. Maternal, pregnancy, and neonatal outcomes will be obtained prospectively and through cord blood analysis.

Results: The primary outcome is the resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at 6 weeks postpartum following IV iron administration. Secondary outcomes include mean changes in ferritin and TSAT within 6 weeks of infusion and at 6-8 weeks postpartum, patient-reported quality of life, safety outcomes (rates of minor and major infusion reactions), maternal obstetric outcomes (blood transfusion, mode of delivery, postpartum hemorrhage), maternal hemoglobin at delivery, neonatal outcomes (birth weight for gestational age, Apgar score, cord blood analysis), total time spent in the infusion clinic, and the impact of iron repletion on hemostasis. A sample size of 65 patients will provide at least 90% power to detect a significant difference pre- and post-IV FDI administration, assuming a 60% response rate for IV iron and a 20% loss to follow-up or discontinuation.

Conclusion: This study will provide critical data on the safety and efficacy of IV FDI in treating iron deficiency anemia in pregnant individuals. The findings could support the use of IV FDI as a more efficient and less burdensome treatment option compared to current IV iron formulations, potentially improving both maternal and neonatal outcomes through effective iron repletion.