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 wome

Phase 4

Completed

• Conditions: Iron deficiency; post partum depression; Blood - Anaemia

• Registration Number: ACTRN12615000950561
• Lead Sponsor: yell McEwin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-10
• Study Completion: 2018-11-30
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 306

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified