Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
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.
|Anemia, Iron-Deficiency Puerperal Disorders Depression, Postpartum||Drug: Ferric carboxymaltose Drug: Ferrous sulfate tablets||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia|
- Haemoglobin concentration [ Time Frame: 6 weeks ]
- Ferritin [ Time Frame: 6 weeks ]
- Fatigue [ Time Frame: 6 weeks ]Fatigue scale
- Quality of life [ Time Frame: 6 weeks ]SF-36
- Post partum depression [ Time Frame: 6 weeks ]Edinburgh Post Partum Depression Scale
|Study Start Date:||June 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Peroral iron - ferrous sulfate tablets
Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Drug: Ferrous sulfate tablets
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Other Name: Duroferon
Active Comparator: Ferric carboxymaltose
Intravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given.
Drug: Ferric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Other Name: Ferinject
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929409
|Department of Obstetrics, Vestre Viken Hospital Trust|
|Drammen, Norway, 3004|
|Sykehuset Innlandet HF|
|Lillehammer, Norway, N 2609|
|St Olavs Hospital|
|Trondheim, Norway, N 7006|
|Principal Investigator:||Bjorn Backe, MD PhD||Norwegian University of Science and Technology|