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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours
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
Time frame: from randomization to delivery
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)
Time frame: The day after delivery
Type and rate of adverse events
Time frame: Up to 30 weeks
The rate of patients who discontinued treatment
Time frame: Up to 30 weeks
The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization
Time frame: 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
Time frame: Up to 30 weeks
The need for blood transfusion post partum
Time frame: up to 4 days post partum
The need for iron sucrose administration post partum
Time frame: up to 4 days post partum
The rate of anemia associated symptoms
Time frame: From randomization and up to 30 weeks
The levels of neonatal hemoglobin, ferritin and bilirubin
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Time frame: up to 4 days post partum
The rate of neonatal polycythemia and need for phototherapy
Time frame: up to 4 days post partum