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

Phase 1

Completed

• Conditions: Prevention of Anemia
• Interventions: Drug: Iron

• Registration Number: NCT02957643
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-10-12
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-08
• Primary Completion: 2017-09
• Study Completion: 2017-09-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregnant women with anemia	Iron	iron dosage 1 per day for 6 months
pregnant women	Iron	iron dosage 1 per day for 3 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adverse reactions	up to 24 months	adverse reactions