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.
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
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)
Parallel
Iron Isomaltoside 1000, ferric derisomaltose
Drugiron isomaltoside 20 mg/mL
Iron sucrose
Drugiron sucrose 100 mg/mL
Correction of anemia
defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre) for all participants
Correction of anemia
defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre), all participants of clinical trial
Correction of anemia
defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre), all participants
Participant's tolerance to IV iron infusion
Tolerance of IV (intravenous) iron infusion (assigned arm)-subjective data collection/ collection of data for adverse events if applicable/ All participants
Comparison of participant's pregnancy related symptoms- subjective measure
Measure of pregnancy related symptoms from each point in the clinical trial -subjective data collection/ All participants
Convenience/barriers of IV iron appointment(s)- subjective measure
Measure of participant's convenience of appointment and barriers to accessing the IV iron- subjective data collection
Changes in Participant's Mental Health and Physical Well-Being
Comparison of participant's physical and mental well being changes across the span of the study- subjective data collection for all participants
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Saskatchewan Health Authority - Regina Area
Lead sponsor
Saskatchewan Centre for Patient-Oriented Research
Collaborator
