Clinical trial NCT02441439: To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy
Official title: To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery
timeFrame: from randomization to delivery
measure: Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)
timeFrame: The day after delivery
Secondary outcomes:
measure: Type and rate of adverse events
timeFrame: Up to 30 weeks
measure: The rate of patients who discontinued treatment
timeFrame: Up to 30 weeks
measure: The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization
timeFrame: Up to 4 weeks
measure: 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
timeFrame: Up to 30 weeks
measure: The need for blood transfusion post partum
timeFrame: up to 4 days post partum
measure: The need for iron sucrose administration post partum
timeFrame: up to 4 days post partum
measure: The rate of anemia associated symptoms
timeFrame: From randomization and up to 30 weeks
measure: The levels of neonatal hemoglobin, ferritin and bilirubin
timeFrame: up to 4 days post partum
measure: The rate of neonatal polycythemia and need for phototherapy
timeFrame: up to 4 days post partum
Other outcomes:
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