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| ID | Type | Description | Link |
|---|---|---|---|
| 21830 | Other Identifier | NSD, Norway | |
| 09/03045-4 | Other Identifier | SLV, Norway | |
| 2008-008526-79 | EudraCT Number |
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Stopped prematurely because too few patients were recruited.
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Sykehuset Innlandet HF | OTHER |
| Sykehuset Buskerud HF | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peroral iron - ferrous sulfate tablets | Active Comparator | Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily |
|
| Ferric carboxymaltose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin concentration | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | 6 weeks | |
| Fatigue | Fatigue scale | 6 weeks |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjorn Backe, MD PhD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics, Vestre Viken Hospital Trust | Drammen | 3004 | Norway | |||
| Sykehuset Innlandet HF |
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|
| Ferrous sulfate tablets | Drug | Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily |
|
|
SF-36 |
| 6 weeks |
| Post partum depression | Edinburgh Post Partum Depression Scale | 6 weeks |
| Lillehammer |
| N 2609 |
| Norway |
| St Olavs Hospital | Trondheim | N 7006 | Norway |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D011644 | Puerperal Disorders |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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