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The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Iron Group | Experimental |
| |
| Oral Iron Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug | single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. - infusion set will be covered for blinding |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin concentration (g/dL) | To evaluate the increase in hemoglobin level | Six weeks after intervention |
| Serum iron concentration | To evaluate the increase in serum iron concentration (µmol/L) | Six weeks after intervention |
| Serum ferritin concentration | serum ferritin levels (µg/L) | six weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| General fatigue score | Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue. | Six weeks after intervention |
| Number of participants that had adverse effects to intravenous iron |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Yim Chue Wai, MBBS | Contact | +603-79493133 | drcarolyim@um.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Centre | Recruiting | Petaling Jaya | Kuala Lumpur | 59100 | Malaysia |
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| Placebo | Drug | 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. - infusion set will be covered for blinding |
|
| Iberet-Folic-500 | Drug | once a day dose, to start 5 days after the intervention |
|
Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol. |
| Up to six weeks after intervention |
| Blood transfusion requirement | Number of blood transfusions required after intervention | Up to six weeks after intervention |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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