Actively Recruiting
Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Led by Saskatchewan Health Authority - Regina Area · Updated on 2025-05-15
280
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
S
Saskatchewan Health Authority - Regina Area
Lead Sponsor
S
Saskatchewan Centre for Patient-Oriented Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age and over
- Pregnant with gestational age 13 weeks or more
- Iron deficiency anemia defined by hemoglobin less than or equal to 110 g/L and serum ferritin less than 30 ng/mL or iron saturation less than 20%
- Willing to participate and attend all planned follow-up visits
- Willing to sign informed consent
- Willing to attend appointments for iron infusion and bloodwork
You will not qualify if you...
- Pregnancy with gestational age less than 13 weeks
- History of anemia caused by thalassemia or other blood disorders except iron deficiency anemia
- Known serious hypersensitivity to other intravenous iron products
- Iron overload conditions such as haemochromatosis or haemosiderosis
- Decompensated liver cirrhosis or active hepatitis
- History of multiple allergies
- Active acute or chronic infections
- Treatment with IV iron or blood transfusion within 4 weeks prior to inclusion
- Current participation in another interventional trial
- Multiple gestation pregnancy
- Significant comorbidities including asthma requiring daily therapy, other lung diseases, heart disease, kidney disease, rheumatologic disease, or cancer
- Known hypersensitivity to iron sucrose or iron isomaltoside or their components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Actively Recruiting
Research Team
R
Ryan Lett, MD FRCPC
CONTACT
S
Sarah Smith, MD, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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