NDLI: Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Prick, B. W. Jansen, A. J. G. Steegers, E. A. P. Hop, W. C. J. Essink-Bot, M. L. Uyl-de Groot, C. A. Akerboom, B. M. C. Van Alphen, M. Bloemenkamp, K. W. M. Boers, K. E. Bremer, H. A. Kwee, A. Van Loon, A. J. Metz, G. C. H. Papatsonis, D. N. M. Van Der Post, J. A. M. Porath, M. M. Rijnders, R. J. P. Roumen, F. J. M. E. Scheepers, H. C. J. Schippers, D. H. Schuitemaker, N. W. E. Stigter, R. H. Woiski, M. D. Mol, B. W. J. Van Rhenen, D. J. Duvekot, J. J.
Spatial Coverage	Netherlands
Description	Country affiliation: Netherlands Author Affiliation: Prick BW ( Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands)
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 OUTCOME MEASURES: 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.
File Format	HTM / HTML
ISSN	14700328
e-ISSN	14710528
Journal	BJOG: An International Journal of Obstetrics & Gynaecology
Issue Number	8
Volume Number	121
Language	English
Publisher	Wiley
Publisher Date	2014-07-01
Publisher Place	Great Britain (UK)
Access Restriction	Open
Subject Keyword	Discipline Obstetrics Discipline Gynecology Anemia Therapy Erythrocyte Transfusion Fatigue Maternal Welfare Postpartum Hemorrhage Etiology Hospitals, University Netherlands Practice Guidelines As Topic Quality Of Life Risk Assessment Severity Of Illness Index Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Obstetrics and Gynecology

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