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Clinical Trials/ACTRN12615000950561
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.

Registry
who.int
Start Date
September 10, 2015
End Date
November 30, 2018
Last Updated
4 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
yell McEwin Hospital

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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