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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

Primary Purpose

Pregnancy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron sucrose 200 mg
Iron sucrose 500 mg
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Iron sucrose 200 mg

    Iron sucrose 500 mg

    Arm Description

    first arm will be treated with iron sucrose 200 mg 2-3 times a week

    Second arm will be treated with iron sucrose 500 mg once a week

    Outcomes

    Primary Outcome Measures

    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
    Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)

    Secondary Outcome Measures

    Type and rate of adverse events
    The rate of patients who discontinued treatment
    The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization
    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
    The need for blood transfusion post partum
    The need for iron sucrose administration post partum
    The rate of anemia associated symptoms
    The levels of neonatal hemoglobin, ferritin and bilirubin
    The rate of neonatal polycythemia and need for phototherapy

    Full Information

    First Posted
    May 6, 2015
    Last Updated
    November 7, 2022
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02441439
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The investigators decided not to proceed with this study
    Study Start Date
    January 1, 2022 (Actual)
    Primary Completion Date
    November 7, 2022 (Actual)
    Study Completion Date
    November 7, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iron sucrose 200 mg
    Arm Type
    Other
    Arm Description
    first arm will be treated with iron sucrose 200 mg 2-3 times a week
    Arm Title
    Iron sucrose 500 mg
    Arm Type
    Active Comparator
    Arm Description
    Second arm will be treated with iron sucrose 500 mg once a week
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron sucrose 200 mg
    Intervention Description
    I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron sucrose 500 mg
    Intervention Description
    I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours
    Primary Outcome Measure Information:
    Title
    The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery
    Description
    Hemoglobin levels will be obtained at the beginning of the study and around delivery
    Time Frame
    from randomization to delivery
    Title
    Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)
    Time Frame
    The day after delivery
    Secondary Outcome Measure Information:
    Title
    Type and rate of adverse events
    Time Frame
    Up to 30 weeks
    Title
    The rate of patients who discontinued treatment
    Time Frame
    Up to 30 weeks
    Title
    The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization
    Time Frame
    Up to 4 weeks
    Title
    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
    Title
    The need for blood transfusion post partum
    Time Frame
    up to 4 days post partum
    Title
    The need for iron sucrose administration post partum
    Time Frame
    up to 4 days post partum
    Title
    The rate of anemia associated symptoms
    Time Frame
    From randomization and up to 30 weeks
    Title
    The levels of neonatal hemoglobin, ferritin and bilirubin
    Time Frame
    up to 4 days post partum
    Title
    The rate of neonatal polycythemia and need for phototherapy
    Time Frame
    up to 4 days post partum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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