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

Sponsor
Hippocration General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02957643
Collaborator
(none)
50
Enrollment
2
Arms
10
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Iron Defieciency Anemia
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: pregnant women

iron dosage 1 per day for 3 months

Drug: Iron
oral treatment
Other Names:
  • oral iron

    		•
    Experimental: pregnant women with anemia

    iron dosage 1 per day for 6 months

    Drug: Iron
    oral treatment
    Other Names:
  • oral iron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire [up to 24 months]

      Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant

    Secondary Outcome Measures

    1. adverse reactions [up to 24 months]

      adverse reactions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hippocration General Hospital

    Investigators

    • Principal Investigator: PANAGIOTIS MATSOUKATIDIS, MD,Msc, Aristotle University Of Thessaloniki, School of Medicine
    • Principal Investigator: CHARALABOS KOLVATZIS, MD, Aristotle University Of Thessaloniki, School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ANGELOS DANIILIDIS, Assistant professor of obstetrics and gynaecology A.U.TH., Hippocration General Hospital
    ClinicalTrials.gov Identifier:
    NCT02957643
    Other Study ID Numbers:
    • HippokratioGH
    First Posted:
    Nov 8, 2016
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Anemia
    Iron

    Study Results

    No Results Posted as of Jul 29, 2020