Status:
COMPLETED
Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies
Lead Sponsor:
Clinica Fabia Mater
Conditions:
Pregnancy
Iron Deficiency
Eligibility:
FEMALE
20-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether bovine lactoferrin is effective in preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia affected women during ...
Detailed Description
In industrialized and developing countries, iron deficiency (ID) and iron deficiency anemia (IDA) are highly prevalent in pregnant women. ID and IDA, in pregnant women as a consequence of an increased...
Eligibility Criteria
Inclusion
- pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S.
- pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA)
- different trimester of pregnancy
- previous miscarriage/s
- previous preterm delivery/ies
- iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells \<4.000.000/mL, the hemoglobin concentration ≤ 11 g/dL, the total serum iron ≤ 30 mg/dL and serum ferritin ≤12 ng/mL.
Exclusion
- absence of iron deficiency and iron deficiency anemia
- non-pregnant women
- uncomplicated pregnancies
- no informed consent
- other treatments of iron supplementation
- recent blood transfusion
- other concomitant diseases
- ascertained allergy to milk proteins or to iron products.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01221844
Start Date
February 1 2010
End Date
May 1 2011
Last Update
June 27 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinica Fabia Mater
Rome, Rm, Italy