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Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

Primary Purpose

Anemia, Iron Deficiency, Pregnancy Anemia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Venofer 200 MG Per 10 ML Injection
Ferinject
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Iron Deficiency

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: pregnancy>24 weeks of gestation anemia with Hb<8 anemia with Hb<9 if symptomatic anemia of previous postpartum hemorrhage Exclusion Criteria: Allergy to one of the study's drugs IV iron treatment in the last month chronic anemia- thalassemia, renal failure Twins pregnancy non iron deficiency anemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    venofer

    Ferinject

    Arm Description

    Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer

    Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject

    Outcomes

    Primary Outcome Measures

    ratio of women with Hb level >11 at delivery
    Hb level
    postpartum Hb level
    gr/dl

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Western Galilee Hospital-Nahariya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061393
    Brief Title
    Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
    Official Title
    Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    September 20, 2025 (Anticipated)
    Study Completion Date
    September 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Galilee Hospital-Nahariya

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    venofer
    Arm Type
    Active Comparator
    Arm Description
    Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer
    Arm Title
    Ferinject
    Arm Type
    Active Comparator
    Arm Description
    Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject
    Intervention Type
    Drug
    Intervention Name(s)
    Venofer 200 MG Per 10 ML Injection
    Intervention Description
    treat anemia with venofer up to 5 doses
    Intervention Type
    Drug
    Intervention Name(s)
    Ferinject
    Intervention Description
    ferinject 500 mg, once a week for 2 weeks
    Primary Outcome Measure Information:
    Title
    ratio of women with Hb level >11 at delivery
    Description
    Hb level
    Time Frame
    at delivery
    Title
    postpartum Hb level
    Description
    gr/dl
    Time Frame
    during 48 hours after delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    pregnant women
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pregnancy>24 weeks of gestation anemia with Hb<8 anemia with Hb<9 if symptomatic anemia of previous postpartum hemorrhage Exclusion Criteria: Allergy to one of the study's drugs IV iron treatment in the last month chronic anemia- thalassemia, renal failure Twins pregnancy non iron deficiency anemia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    maya Wolf, MD
    Phone
    972507887800
    Email
    mayaw@gmc.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

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