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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Regina General Hospital
RECRUITING
Regina
Contact Information
Primary
Ryan Lett, MD FRCPC
ryan.lett@saskhealthuauthority.ca
306-766-3491
Backup
Sarah Smith, MD, BSc
sarah.Naden.Smith@gmail.com
306-352-4963
Time Frame
Start Date: 2022-06-06
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 280
Treatments
Active_comparator: Iron Isomaltoside/ferric derisomaltose
route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)
Active_comparator: Iron Sucrose
Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table
Related Therapeutic Areas
Sponsors
Collaborators: Saskatchewan Centre for Patient-Oriented Research
Leads: Saskatchewan Health Authority - Regina Area

This content was sourced from clinicaltrials.gov