Status:
RECRUITING
Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Collaborating Sponsors:
Saskatchewan Centre for Patient-Oriented Research
Conditions:
Iron Deficiency Anaemia in Childbirth
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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 late...
Detailed Description
IDA is associated with poor neonatal outcomes and maternal morbidity. This clinical trial will compare IV iron isomaltoside to IV iron sucrose for correction of IDA, along with the potential impacts t...
Eligibility Criteria
Inclusion
- 18 years of age and over
- Pregnancy with Gestational age ≥13 weeks
- Iron deficiency anemia defined as:
- Hemoglobin less than or equal to 110g/L and
- Serum ferritin less than 30ng/mL or
- Iron Saturation (Iron/TIBC) less than 20%
- Willing to participate and attend all planned follow up visits
- Willing to sign informed consent form
- Willing to attend appointments for iron infusion and follow up visits
- Willing to attend all planned bloodwork appointments
Exclusion
- 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)
- Decompensated liver cirrhosis or active hepatitis
- History of multiple allergies
- Active acute or chronic infections
- Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
- Current participation in any other interventional trial
- Multiple gestation pregnancy
- Significant comorbidities (asthma requiring daily therapy or other lung diseases)
- Heart disease
- Kidney disease
- Rheumatologic disease
- Cancer
- Known hypersensitivity to iron sucrose or any excipients
- Known hypersensitivity to iron isomaltoside or any excipients.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05251493
Start Date
June 6 2022
End Date
February 28 2027
Last Update
May 15 2025
Active Locations (1)
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1
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5