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

• Status: Recruiting
• Trial end date: 2022-07-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• Postpartum patients with a hemoglobin level between 70 g/L and 100 g/L within 48 hours after delivery.

Exclusion Criteria:

• Contraindications for any of the study drugs.

• Anemia due to causes other than iron deficiency.

• Signs of systemic infection.

• Renal or hepatic dysfunction.

• Depression during pregnancy or pre-existing depressive disorders.