drugset / Trial / NCT03957057

Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia

NCT03957057

Phase 3 Completed 300 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupOpen-labelTreatment

Summary

Anemia affects between 20 and 50 % of women in the postpartum period. It is associated with several adverse health consequences, such as impaired physical work capacity, deficits in cognitive function and mood, reduced immune function and reduced duration of breastfeeding. Postpartum anemia has also been shown to be a major risk factor for postpartum depression and to significantly disrupt maternal-infant interactions. Iron deficiency is the principal cause of anemia after delivery. Oral iron supplementation with ferrous sulfate has been considered the standard of care with blood transfusion reserved for more severe or symptomatic cases. In the last decade, two new intravenous iron compounds have been registered for clinical use: ferric carboxymaltose (Iroprem®) and iron isomaltoside (Monofer®). No study to date compared efficacy of iron carboxymaltose to iron isomaltoside for treatment of postpartum anemia. The objective of the study is to compare efficacy of intravenous iron carboxymaltose to intravenous iron isomaltoside and oral iron sulphate for treatment of postpartum anemia.

Timeline

Start
2020-09-10
Primary completion
2022-04-30
Completion
2022-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Subject Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 160 mg Oral
Subject Iron isomaltoside 1000 Unknown 20 mg/kg Intravenous
Subject Iron isomaltoside 1000 Unknown 1500 mg Intravenous