About this trial
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 criteria
Qualifiers
18 years of age and over
Pregnancy with Gestational age ≥13 weeks
Hemoglobin less than or equal to 110g/L and
Serum ferritin less than 30ng/mL or
Disqualifiers
Pregnancy GA less than 13 weeks
History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
Known serious hypersensitivity to other parental iron products
Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
Trial design
Treatments tested in this trial
- Iron Isomaltoside 1000, ferric derisomaltose
- Iron sucrose
Treatment groups
Sponsors and collaborators
Saskatchewan Health Authority - Regina Area
Lead sponsor
Saskatchewan Centre for Patient-Oriented Research
Collaborator