To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Iron sucrose 200 mg
* Dietary Supplement: Iron sucrose 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Iron deficiency anemia Intolerance or low compliance for oral iron Exclusion Criteria: Known allergy for iron supplements Anemia not due to iron deficiency Acute infection Liver failure or viral hepatitis Thalassemia or hemoglobinopathies Asthma Multiple pregnancy

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Iron sucrose 200 mg<br>first arm will be treated with iron sucrose 200 mg 2-3 times a week | Dietary Supplement: Iron sucrose 200 mg<br>* I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes<br>|
| Active Comparator: Iron sucrose 500 mg<br>Second arm will be treated with iron sucrose 500 mg once a week | Dietary Supplement: Iron sucrose 500 mg<br>* I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours<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 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |