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RECRUITING
NCT05251493
PHASE3

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

Sponsor: Saskatchewan Health Authority - Regina Area

View on ClinicalTrials.gov

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

Interventions

DRUG

Iron Isomaltoside 1000, ferric derisomaltose

iron isomaltoside 20 mg/mL

DRUG

Iron sucrose

iron sucrose 100 mg/mL

Locations (1)

Regina General Hospital

Regina, Saskatchewan, Canada