Comparing Iron Isomaltoside 1000, ferric with Iron sucrose for iron deficiency anaemia in childbirth
Official title: Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial
- Phase 3
- 2 groups
- One site, in Regina
- Recruiting
Interventions
- Medication
Iron Isomaltoside 1000, ferric derisomaltose
iron isomaltoside 20 mg/mL
- Medication
Iron sucrose
iron sucrose 100 mg/mL
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Regina General Hospital
Regina, Saskatchewan
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Pregnancy with Gestational age ≥13 weeks
- +18 years of age and over
- +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 upFollow-upContinued check-ins after the treatment part is finished.Read more → visits
- +Willing to sign informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Willing to attend appointments for iron infusion and follow up visits
- +Willing to attend all planned bloodwork appointments
Exclusion
- −Known serious hypersensitivity to other parental iron products
- −History of multiple allergies
- −Known hypersensitivity to iron sucrose or any excipients
- −Known hypersensitivity to iron isomaltoside or any excipients.
- −Decompensated liver cirrhosis or active hepatitis
- −History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
- −Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
- −Active acute or chronic infections
- −Treated with IV iron products or blood transfusion within 4 weeks prior to inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- −Current participation in any other interventional trialInterventional studyA study where participants are given something to see what happens.Read more →
- −Significant comorbidities (asthma requiring daily therapy or other lung diseases)
- −Heart disease
- −Kidney disease
- −Rheumatologic disease
- −Pregnancy GA less than 13 weeks
- −Multiple gestation pregnancy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Iron Isomaltoside 1000, ferric derisomaltose.
Registry label: A: Iron Isomaltoside/ferric derisomaltose
Group B, the comparison group, receives Iron sucrose.
Registry label: B: Iron Sucrose
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 50 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 280 people.
The study is currently expected to finish around February 2027.
The main measurement is taken over: 30 days post iron infusion.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Correction of anemia — measured over 30 days post iron infusion.
Correction of anemia — measured over at delivery admission.
Correction of anemia — measured over 6 week post partum visit.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05251493 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Iron Isomaltoside 1000, ferric derisomaltoseDrug
iron isomaltoside 20 mg/mL
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Iron sucroseDrug
iron sucrose 100 mg/mL
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 50 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 days post iron infusion.
The study as a whole is currently expected to finish around 2027-02-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 280 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Regina, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.