Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial

What this Trial Is About

Iron deficiency anemia during pregnancy can lead to poor outcomes for the newborn and health problems for the mother. This trial compares two types of intravenous iron treatments, iron isomaltoside and iron sucrose, to correct iron deficiency anemia in pregnant women. Researchers aim to evaluate which treatment requires fewer visits and to assess physical, emotional, and healthcare resource impacts. The study focuses on pregnant women at 13 weeks gestation or later who have moderate to severe anemia. Participants will be randomly assigned to one of two groups: one receiving a single dose of IV iron isomaltoside and the other receiving standard iron sucrose therapy. Iron isomaltoside doses range from 1000 to 1500 mg given in one or two infusions, while iron sucrose doses are up to 300 mg per dose, given up to three times per week until iron needs are met. The study includes screening, iron infusion, delivery, and follow-up visits up to 6 weeks postpartum. During the study, participants will have blood tests and assessments at baseline, about 30 days after infusion, at delivery, and 6 weeks after delivery. Researchers will collect data on hemoglobin levels, participant tolerance to the iron infusion, pregnancy symptoms, mental and physical well-being, convenience of appointments, and bonding with the baby. The main goal is to measure correction of anemia with hemoglobin levels at or above 110 g/L after treatment and at delivery and postpartum. Safety and quality of life data will also be monitored throughout the study, which lasts about 231 days per participant.

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy