RecruitingPhase 3NCT05251493

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

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


Sponsor

Saskatchewan Health Authority - Regina Area

Enrollment

280 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Iron Isomaltoside 1000, ferric derisomaltose and a drug called Iron sucrose for people with iron deficiency anaemia in childbirth. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIron Isomaltoside 1000, ferric derisomaltose

iron isomaltoside 20 mg/mL

DRUGIron sucrose

iron sucrose 100 mg/mL


Locations(1)

Regina General Hospital

Regina, Saskatchewan, Canada

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NCT05251493


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