title: Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.
abstract: OBJECTIVE
  To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.
  
  
  METHODS
  Randomised non-inferiority trial.
  
  
  METHODS
  Thirty-seven Dutch university and general hospitals.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands; Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: B W
authors.initials: BW
authors.lastname: Prick
authors.forename: A J G
authors.initials: AJ
authors.lastname: Jansen
authors.forename: E A P
authors.initials: EA
authors.lastname: Steegers
authors.forename: W C J
authors.initials: WC
authors.lastname: Hop
authors.forename: M L
authors.initials: ML
authors.lastname: Essink-Bot
authors.forename: C A
authors.initials: CA
authors.lastname: Uyl-de Groot
authors.forename: B M C
authors.initials: BM
authors.lastname: Akerboom
authors.forename: M
authors.initials: M
authors.lastname: van Alphen
authors.forename: K W M
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: K E
authors.initials: KE
authors.lastname: Boers
authors.forename: H A
authors.initials: HA
authors.lastname: Bremer
authors.forename: A
authors.initials: A
authors.lastname: Kwee
authors.forename: A J
authors.initials: AJ
authors.lastname: van Loon
authors.forename: G C H
authors.initials: GC
authors.lastname: Metz
authors.forename: D N M
authors.initials: DN
authors.lastname: Papatsonis
authors.forename: J A M
authors.initials: JA
authors.lastname: van der Post
authors.forename: M M
authors.initials: MM
authors.lastname: Porath
authors.forename: R J P
authors.initials: RJ
authors.lastname: Rijnders
authors.forename: F J M E
authors.initials: FJ
authors.lastname: Roumen
authors.forename: H C J
authors.initials: HC
authors.lastname: Scheepers
authors.forename: D H
authors.initials: DH
authors.lastname: Schippers
authors.forename: N W E
authors.initials: NW
authors.lastname: Schuitemaker
authors.forename: R H
authors.initials: RH
authors.lastname: Stigter
authors.forename: M D
authors.initials: MD
authors.lastname: Woiski
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
authors.forename: D J
authors.initials: DJ
authors.lastname: van Rhenen
authors.forename: J J
authors.initials: JJ
authors.lastname: Duvekot
mesh_terms: D000328:Adult; D000740:Anemia / Q000209:etiology / Q000628:therapy*; D017707:Erythrocyte Transfusion / Q000592:standards*; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006769:Hospitals, General; D006785:Hospitals, University; D006801:Humans; D008429:Maternal Welfare; D009426:Netherlands; D006473:Postpartum Hemorrhage / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: Anaemia; blood transfusion; postpartum haemorrhage; quality of life