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Intravenous Treatment of Anemia in Pregnancy

Primary Purpose

Anemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
iron sucrose (200 mg VENOFER®)
recombinant human erythropoietin (10,000 U EPREX®)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

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

Inclusion Criteria:

  • pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l

Exclusion Criteria:

  • vitamin B12 deficiency anemia
  • folic acid deficiency anemia
  • hemoglobinopathy
  • multiples
  • liver disease
  • kidney disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    iron therapy with good response

    iron therapy with poor response

    iron therapy and erythropoietin

    Arm Description

    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.

    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase <0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).

    Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.

    Outcomes

    Primary Outcome Measures

    Efficacy of Treatment: hemoglobin increase after therapy
    In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted.The hematological parameters were checked twice a week in the anemia clinic and iron status once a week.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 23, 2017
    Last Updated
    October 31, 2017
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03317210
    Brief Title
    Intravenous Treatment of Anemia in Pregnancy
    Official Title
    Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2002 (Actual)
    Primary Completion Date
    July 31, 2006 (Actual)
    Study Completion Date
    July 31, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.
    Detailed Description
    Fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the Anemia clinic at the Department of Obstetrics, University Hospital Zurich. All patients had singleton pregnancies. All pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (Hb) between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l. In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted. According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly. Patients with an Hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (VENOFER®, Vifor Int., St. Gallen, Switzerland) intravenously twice weekly (group A). If response to therapy was poor (i.e. Hb increase <0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhEPO (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland) (group B). This cut-off for adequate primary response the investigators choose on the basis of previous experience. Patients with an Hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (Venofer) and rhEPO (Eprex) twice weekly from the start of therapy (group C). Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase >1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    iron therapy with good response
    Arm Type
    Other
    Arm Description
    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.
    Arm Title
    iron therapy with poor response
    Arm Type
    Other
    Arm Description
    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase <0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).
    Arm Title
    iron therapy and erythropoietin
    Arm Type
    Other
    Arm Description
    Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    iron sucrose (200 mg VENOFER®)
    Other Intervention Name(s)
    Venofer
    Intervention Description
    According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    recombinant human erythropoietin (10,000 U EPREX®)
    Other Intervention Name(s)
    Eprex
    Intervention Description
    According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
    Primary Outcome Measure Information:
    Title
    Efficacy of Treatment: hemoglobin increase after therapy
    Description
    In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted.The hematological parameters were checked twice a week in the anemia clinic and iron status once a week.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l Exclusion Criteria: vitamin B12 deficiency anemia folic acid deficiency anemia hemoglobinopathy multiples liver disease kidney disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roland Zimmermann, Prof.
    Organizational Affiliation
    University of Zurich
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intravenous Treatment of Anemia in Pregnancy

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