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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Ferric carboxymaltose
* Drug: Ferrous sulfate tablets


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peroral iron - ferrous sulfate tablets<br>Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily | Drug: Ferrous sulfate tablets<br>* Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily<br>* Other names: Duroferon;|
| Active Comparator: Ferric carboxymaltose<br>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<br>* Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula<br>* Other names: Ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin concentration |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin |  | 6 weeks | 
| Fatigue | Fatigue scale | 6 weeks | 
| Quality of life | SF-36 | 6 weeks | 
| Post partum depression | Edinburgh Post Partum Depression Scale | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum anemia, iron-deficiency