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Disapointing randomization rate
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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
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The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.
Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.
The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject | Active Comparator | Once an infusion of Ferinject 1000 mg, 1 day after surgery |
|
| Ferrous fumarate | Active Comparator | 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery |
|
| Placebo infusion and tablets | Placebo Comparator | Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Serum hemoglobin level | 3 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin | Serum levels of ferritin | 3 weeks postoperative |
| Serum Hepcidin | Serum hepcidin level | 3 weeks postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Kruitwagen | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | Limburg | 6202 AZ | Netherlands | ||
| Orbis Medical Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferinject | Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate |
| FG001 | Ferrous Fumarate | 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject |
| FG002 | Placebo Infusion and Tablets | Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery Placebo for ferrous fumarate Placebo for ferinject |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A significant number of patients were lost to follow-up: 2 patients Ferinject group, 4 patients Ferrous fumarate group, and 2 patients placebo group.
Most likely reason: no complaints in a phase in which attention to the newborn was given priority.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferinject | Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate |
| BG001 | Ferrous Fumarate | 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin | Serum hemoglobin level | Posted | Mean | Full Range | mmol/L | 3 weeks postoperative |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferinject | Once an infusion of Ferinject 1000 mg, 1 day after surgery Ferinject Placebo for ferrous fumarate |
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Evident conclusions cannot be drawn from this small prematurely stopped study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. dr. Roy Kruitwagen | Maastricht University Medical Centre | 0031-3874764 | r.kruitwagen@mumc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2016 | Jan 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C031621 | ferrous fumarate |
| D007501 | Iron |
| D005650 | Fumarates |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Ferrous fumarate |
| Drug |
|
|
| Placebo for ferrous fumarate | Drug |
|
|
| Placebo for ferinject | Drug |
|
|
| Sittard |
| Limburg |
| 6162 BG |
| Netherlands |
| BG002 | Placebo Infusion and Tablets | Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery Placebo for ferrous fumarate Placebo for ferinject |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Serum Ferritin | Serum levels of ferritin | Posted | Mean | Full Range | microgram/L | 3 weeks postoperative |
|
|
|
| Secondary | Serum Hepcidin | Serum hepcidin level | Posted | Mean | Full Range | nmol/L | 3 weeks postoperative |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Ferrous Fumarate | 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Ferrous fumarate Placebo for ferinject | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Placebo Infusion and Tablets | Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery Placebo for ferrous fumarate Placebo for ferinject | 0 | 8 | 0 | 8 | 0 | 8 |
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| D008670 |
| Metals |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|