Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).

The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Sykehuset Buskerud HF; Sykehuset Innlandet HF
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Woman within 48 h post partum

• Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl

• Able to read and understand the Norwegian language

• Signed informed consent

Exclusion Criteria:

• Anemia not attributable to iron deficiency

• Contraindications for any of the study drugs

• Treatment with drugs, dietary supplements or natural remedies containing iron

• Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study

• Assessed as requiring blood transfusion(s)