ACTRN12615000950561
Completed
Phase 4
A study to assess whether two different doses of antenatal intravenous iron administration (500 mg and 1000mg ferric carboxymaltose) are equivalent in replenishing and sustaining iron stores successfully in pregnant iron deficient women
yell McEwin Hospital0 sites306 target enrollmentSeptember 10, 2015
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- yell McEwin Hospital
- Enrollment
- 306
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women (2nd and 3rd trimester) with iron deficiency (serum ferritin \<15mcg/mL) ; if elevated CRP then serum ferritin \<50mcg/mL and TSAT \<20%).
Exclusion Criteria
- •1\.Patients with B12 pmol/L or folate nmol/L deficiency that cannot be corrected before trial entry will be excluded.
- •2\.Known hypersensitivity to ferric carboxymaltose or not eligible for dosing per approved Product Insert
- •3\.Haemoglobin (Hb) \>130g/dL
- •4\.Hemochromatosis or other iron storage disorders
- •5\.Serious medical condition, uncontrolled systemic disease or any other medical condition (including an inability to fully comprehend and/or perform study procedures) that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study
Outcomes
Primary Outcomes
Not specified
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