search
Back to results

Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement

Primary Purpose

Prevention of Anemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Iron
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prevention of Anemia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age more or equal of 18 years
  2. Registration consent
  3. Have complete 12h week of pregnancy
  4. Hemoglobin levels <10,5 ptl
  5. Hematocrit < 32 %

Exclusion Criteria:

  1. Age <18 years
  2. Absent registration consent
  3. Step of pregnancy less than 12 weeks
  4. Coadministration formulations iron oral or parenterally
  5. Background of liver kirrosis
  6. Background of aimosidirosis
  7. Background acquired or chronic aimatochromatosis
  8. Aplastic , Hemolytic anemia and chronic diseases
  9. Chronic pancreatitis
  10. Subjective renal or/and liver disease
  11. Hypothyroidism or yperthyreoeidismos

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    pregnant women

    pregnant women with anemia

    Arm Description

    iron dosage 1 per day for 3 months

    iron dosage 1 per day for 6 months

    Outcomes

    Primary Outcome Measures

    Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire
    Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant

    Secondary Outcome Measures

    adverse reactions
    adverse reactions

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    July 27, 2020
    Sponsor
    Hippocration General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02957643
    Brief Title
    Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement
    Official Title
    Treatment of Iron Defieciency Anemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hippocration General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.
    Detailed Description
    The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pregnant women
    Arm Type
    Placebo Comparator
    Arm Description
    iron dosage 1 per day for 3 months
    Arm Title
    pregnant women with anemia
    Arm Type
    Experimental
    Arm Description
    iron dosage 1 per day for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Iron
    Other Intervention Name(s)
    oral iron
    Intervention Description
    oral treatment
    Primary Outcome Measure Information:
    Title
    Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire
    Description
    Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant
    Time Frame
    up to 24 months
    Secondary Outcome Measure Information:
    Title
    adverse reactions
    Description
    adverse reactions
    Time Frame
    up to 24 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age more or equal of 18 years Registration consent Have complete 12h week of pregnancy Hemoglobin levels <10,5 ptl Hematocrit < 32 % Exclusion Criteria: Age <18 years Absent registration consent Step of pregnancy less than 12 weeks Coadministration formulations iron oral or parenterally Background of liver kirrosis Background of aimosidirosis Background acquired or chronic aimatochromatosis Aplastic , Hemolytic anemia and chronic diseases Chronic pancreatitis Subjective renal or/and liver disease Hypothyroidism or yperthyreoeidismos
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    PANAGIOTIS MATSOUKATIDIS, MD,Msc
    Organizational Affiliation
    Aristotle University Of Thessaloniki, School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    CHARALABOS KOLVATZIS, MD
    Organizational Affiliation
    Aristotle University Of Thessaloniki, School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    email contact
    IPD Sharing Time Frame
    up to two years upon completion
    IPD Sharing Access Criteria
    email contact

    Learn more about this trial

    Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement

    We'll reach out to this number within 24 hrs