Intravenous iron versus packed cells in acute post-partum anemia

Not Applicable

• Conditions: acute post-partum anemia following blood loss >1000mL; acute post partum anaemia; Reproductive Health and Childbirth - Childbirth and postnatal care; Blood - Anaemia

• Registration Number: ACTRN12615001370594
• Lead Sponsor: Westmead Hospital--Department of Obstetrics and Gynecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

Patients who sustain a primary post-partum haemorrhage in excess of 500mL with a resultant Hb of 5.5-8.0 g/dL within 24 hours of stabilisation and/or have a minimal haemoglobin drop of >3g/dL and are symptomatic (i.e. HR 100-120, dizziness, increased respiratory rate to >/= 25 on minimal exertion or postural drop of BP >10mmHg) will be included.

Exclusion Criteria

women outside of specified age brackets or having religious or other beliefs precluding the use of RBC transfusion, high risk co-morbidities necessitating rapid Hb restoration (e.g. cardiac failure, cardiomyopathy, ischemic heart disease, chronic renal failure), known blood malignancy, known significant haemoglobinopathy requiring regular blood transfusion prior to or during pregnancy clinical or laboratory evidence of sepsis (i.e. positive blood culture or intra-partum fever >38.5 degrees)and any contra-indication to intravenous iron polymaltose infusion (i.e. asthmatic, known hypersensitivity to iron polymaltose, chronic polyarthritis, acute renal dysfunction, uncontrolled hyperparathyroidism, infectious hepatitis, iron overload (ferritin >1000) and non-microcytic anaemia). Patients with severe symptoms displaying dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks will also be excluded even if their vital parameters are within study criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified