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

Hippocration General Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prevention of Anemia

Treatments: Drug: Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT02957643

HippokratioGH

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

pregnant women

Placebo Comparator group

Description:

iron dosage 1 per day for 3 months

Treatment:

Drug: Iron

pregnant women with anemia

Experimental group

Description:

iron dosage 1 per day for 6 months

Treatment:

Drug: Iron