Comparing two types of intravenous iron for treating anemia in pregnant women
Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial
This study is testing whether a new type of intravenous iron can help pregnant women with anemia feel better compared to the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Saskatchewan Health Authority - Regina Area Academic / other |
| Locations | 1 site (Regina, Saskatchewan) |
| Trial ID | NCT05251493 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of iron isomaltoside versus iron sucrose in treating iron deficiency anemia (IDA) in pregnant women during their second and third trimesters. The study will involve a randomized, single-center approach with participants receiving either a single dose of iron isomaltoside or standard iron sucrose therapy. The trial will assess not only the correction of IDA but also the physical, emotional, and logistical impacts on the patients, as well as the implications for the healthcare system. Eligible participants will be screened for IDA and must meet specific inclusion criteria to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and over, with a gestational age of 13 weeks or more, who have been diagnosed with iron deficiency anemia.
Not a fit: Patients who may not benefit from this study include those with anemia due to conditions other than iron deficiency, such as thalassemia or other hematologic disorders.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and effective treatment for iron deficiency anemia in pregnant women, improving maternal and neonatal health outcomes.
How similar studies have performed: Other studies have shown promising results with intravenous iron therapies, but this specific comparison of iron isomaltoside and iron sucrose in pregnant women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Regina, Saskatchewan
- Regina General Hospital — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Ryan Lett, MD, FRCPC — Saskatchewan Health Authority - Regina Area
- Study coordinator: Ryan Lett, MD FRCPC
- Email: ryan.lett@saskhealthuauthority.ca
- Phone: 306-766-3491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.