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| Name | Class |
|---|---|
| BioStata | INDUSTRY |
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The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside 1000 (MonoferĀ®) | Experimental |
| |
| Standard medical Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside 1000 | Drug | A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical fatigue | The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue. | From exposure to 12 weeks post-exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration | From exposure to week 1, 3, 8 and 12 post-exposure | |
| Change in concentrations of p-ferritin | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anaemia symptoms | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | |
| Change in gastrointestinal symptoms | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29558233 | Derived | Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20. | |
| 25588587 | Derived | Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Jan 14;16:5. doi: 10.1186/1745-6215-16-5. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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|
| Standard medical Care | Other | Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day |
|
| Change in Fatigue symptoms |
| From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in postpartum depression symptoms | From exposure to 12 weeks post-exposure |
| Breastfeeding | From exposure to 12 weeks post-exposure |
| RCB transfusions | From exposure to 12 weeks post-exposure |
| Adverse drug reactions (ADRs) | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in concentrations of p-iron | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in concentrations of p-transferrin | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in concentrations of transferrin saturation (TSAT) | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in concentrations of reticulocyte count | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in concentrations of mean reticulocyte haemoglobin content (CHr) | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| Change in haematology parameters | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |