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This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron sucrose 500 mg | Active Comparator | One treatment arm will receive a single dose of I.V iron sucrose 500 mg. |
|
| Iron sucrose 500 mg+60 mg Iron bisglycinate | Active Comparator | Second treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose 500 mg | Dietary Supplement |
| ||
| Iron bisglycinate 60 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum | After 6 weeks post partum |
| Measure | Description | Time Frame |
|---|---|---|
| Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum | Up to 6 weeks post partum | |
| The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emek Medical Center | Afula | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34171389 | Derived | Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23. |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Dietary Supplement |
|
| six weeks post partum |
| Type and rate of adverse events | Up to 6 weeks post partum |
| The rate of patients who discontinued treatment | Up to 6 weeks post partum |
| The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum | From randomization to 6 weeks post partum |
| The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment | Six weeks post partum |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |