Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSaskatchewan Health Authority - Regina Area

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.

Eligibility criteria

Qualifiers

18 years of age and over

Pregnancy with Gestational age ≥13 weeks

Hemoglobin less than or equal to 110g/L and

Serum ferritin less than 30ng/mL or

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Iron Isomaltoside 1000, ferric derisomaltose
  • Iron sucrose

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Saskatchewan Health Authority - Regina Area

Lead sponsor

Saskatchewan Centre for Patient-Oriented Research

Collaborator