NCT00929409

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

A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway. The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery. The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power). Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory. Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.

Conditions

• Anemia, Iron-Deficiency
• Puerperal Disorders
• Depression, Postpartum

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
DRUG	Ferrous sulfate tablets	Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-06-29
• Last updated: 2012-02-17

Locations

3 sites across 1 country: Norway