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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2017

Open Access 01-12-2017 | Study protocol

Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial

Authors: Seng Chua, Sarika Gupta, Jennifer Curnow, Beata Gidaszewski, Marjan Khajehei, Hayley Diplock

Published in: BMC Pregnancy and Childbirth | Issue 1/2017

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Abstract

Background

Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear.

Methods/design

IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire.

Discussion

If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs.

Trial registration

Australian and New Zealand Clinical Trials Registry: ACTRN12615001370​594 on 16th December, 2015 (prospective approval).
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Metadata
Title
Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial
Authors
Seng Chua
Sarika Gupta
Jennifer Curnow
Beata Gidaszewski
Marjan Khajehei
Hayley Diplock
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2017
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-017-1596-x

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