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Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Sponsor: Saskatchewan Health Authority - Regina Area
Summary
Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion. The goal of this clinical trial: * Correct IDA with fewer visits and less impact on the healthcare system * Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.
Official title: Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2022-06-06
Completion Date
2027-02-28
Last Updated
2025-05-15
Healthy Volunteers
Yes
Conditions
Interventions
Iron Isomaltoside 1000, ferric derisomaltose
iron isomaltoside 20 mg/mL
Iron sucrose
iron sucrose 100 mg/mL
Locations (1)
Regina General Hospital
Regina, Saskatchewan, Canada