Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial

HC6-024-c260086 SHA REB-21-64

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.

2022-06-06

2024-12-31

2025-02-28

Recruiting

Early phase I

280

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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 to the patient: physical, emotional and convenience of attending, receiving and follow up appointments associated with iron infusion. The study will also take into consideration the financial and resource impacts to the healthcare system, and to the patient, and determine the validity of using iron isomaltoside and iron sucrose in second and third trimester pregnancy.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2023-11-22