None listed
Conditions
Brief summary
The aim of this study is 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.
Interventions
initially single dose of intravenous ferric carboxymaltose 500mg in 2nd or 3rd trimester
Sponsors
Lyell McEwin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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
Outcome results
None listed