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

Treatment of Iron Defieciency Anemia

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 Overview

• Status: Completed
• Conditions: Prevention of Anemia
• Intervention / Treatment: Drug: Iron

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse reactions	adverse reactions	up to 24 months

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: HippokratioGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: email contact
• IPD Sharing Time Frame: up to two years upon completion
• IPD Sharing Access Criteria: email contact
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR