Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in … (NCT05251493) | Clinical Trial Compass
RecruitingPhase 3
Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Canada280 participantsStarted 2022-06-06
Plain-language 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 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correction of anemia
Timeframe: 30 days post iron infusion
2
Correction of anemia
Timeframe: at delivery admission
3
Correction of anemia
Timeframe: 6 week post partum visit
Trial details
NCT IDNCT05251493
SponsorSaskatchewan Health Authority - Regina Area