Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.
BJOG
; 121(8): 1005-14, 2014 Jul.
Article
em En
| MEDLINE
| ID: mdl-24405687
ABSTRACT
OBJECTIVE:
To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.DESIGN:
Randomised non-inferiority trial.SETTING:
Thirty-seven Dutch university and general hospitals. POPULATION Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities.METHODS:
Women were allocated to RBC transfusion or non-intervention. MAIN OUTCOMEMEASURES:
Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum.RESULTS:
In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable.CONCLUSIONS:
Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Transfusão de Eritrócitos
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Fadiga
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Hemorragia Pós-Parto
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Anemia
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Bem-Estar Materno
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article