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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957643
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
ANGELOS DANIILIDIS, Hippocration General Hospital

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
Prevention of Anemia Drug: Iron 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

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Study Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Placebo Comparator: pregnant women
iron dosage 1 per day for 3 months
Drug: Iron
oral treatment
Other Name: oral iron

Experimental: pregnant women with anemia
iron dosage 1 per day for 6 months
Drug: Iron
oral treatment
Other Name: oral iron




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


Secondary Outcome Measures :
  1. adverse reactions [ Time Frame: up to 24 months ]
    adverse reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957643


Sponsors and Collaborators
Hippocration General Hospital
Investigators
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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
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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: November 8, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: email contact
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: up to two years upon completion
Access Criteria: email contact
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs