A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

Conditions
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Postpartum Anemia

Intervention / Treatment
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* Dietary Supplement: Iron sucrose 500 mg
* Dietary Supplement: Iron bisglycinate 60 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women above 18 years old after giving birth Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the exclusion criteria Exclusion Criteria: Women who suffer from known allergy for iron supplements Women who suffer from anemia not due to iron deficiency Women who suffer from acute infection Women who suffer from liver failure or viral hepatitis Women who suffer from thalassemia or hemoglobinopathies Women who suffer from renal failure Women who suffer from unbalanced thyroid disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron sucrose 500 mg<br>One treatment arm will receive a single dose of I.V iron sucrose 500 mg. | Dietary Supplement: Iron sucrose 500 mg<br> <br> |
| Active Comparator: Iron sucrose 500 mg+60 mg Iron bisglycinate<br>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. | Dietary Supplement: Iron sucrose 500 mg<br> <br> Dietary Supplement: Iron bisglycinate 60 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |