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The investigators decided not to proceed with this study
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This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.
Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron sucrose 200 mg | Other | first arm will be treated with iron sucrose 200 mg 2-3 times a week |
|
| Iron sucrose 500 mg | Active Comparator | Second arm will be treated with iron sucrose 500 mg once a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose 200 mg | Dietary Supplement | I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery | Hemoglobin levels will be obtained at the beginning of the study and around delivery | from randomization to delivery |
| Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) | The day after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Type and rate of adverse events | Up to 30 weeks | |
| The rate of patients who discontinued treatment | Up to 30 weeks | |
| The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Iron sucrose 500 mg | Dietary Supplement | I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours |
|
| Up to 4 weeks |
| The change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from the last dose of iron sucrose to delivery in 3 weeks intervals | Up to 30 weeks |
| The need for blood transfusion post partum | up to 4 days post partum |
| The need for iron sucrose administration post partum | up to 4 days post partum |
| The rate of anemia associated symptoms | From randomization and up to 30 weeks |
| The levels of neonatal hemoglobin, ferritin and bilirubin | up to 4 days post partum |
| The rate of neonatal polycythemia and need for phototherapy | up to 4 days post partum |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |