Depression, Postpartum Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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