Comparing two types of intravenous iron for treating anemia in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment of Iron Deficiency Anemia in Children with Ferric Derisomaltose

  This study is testing if an intravenous iron treatment can help children with iron deficiency anemia who can't take regular iron pills feel better and improve their iron levels.

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• Robot-assisted magnetically controlled capsule endoscopy for iron deficiency anaemia

  This study tests a robot-guided, magnetically controlled capsule to examine the upper GI tract and small bowel in adults with iron deficiency anaemia when standard tests haven’t found a cause.

  Recruiting University of Edinburgh · Edinburgh · NCT07197424

• High- versus low-dose iron treatment for adults on peritoneal dialysis (PALaDIN)

  This project will see if higher-dose versus lower-dose iron treatment helps adults on peritoneal dialysis with iron-deficiency anaemia keep their iron and haemoglobin levels more stable.

  Recruiting Phase 3 Hull University Teaching Hospitals NHS Trust · Hull, East Riding Of Yorkshire · NCT06884280

• Using intravenous iron to treat anemia after heart surgery

  This study is testing if giving intravenous iron to patients with anemia after heart surgery can help them stay out of the hospital and feel better.

  Recruiting at 3 sites Phase 2 University Health Network, Toronto · Kingston, Ontario and 2 other locations · NCT06287619

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.