title: Well being of obstetric patients on minimal blood transfusions (WOMB trial).
abstract: BACKGROUND
  Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands.
  
  
  METHODS
  The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%).
  
  
  CONCLUSIONS
  This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.
authors.affiliation: Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors.forename: Babette W
authors.initials: BW
authors.lastname: Prick
authors.forename: Eric A P
authors.initials: EA
authors.lastname: Steegers
authors.forename: A J Gerard
authors.initials: AJ
authors.lastname: Jansen
authors.forename: Wim C J
authors.initials: WC
authors.lastname: Hop
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Essink-Bot
authors.forename: Nina C J
authors.initials: NC
authors.lastname: Peters
authors.forename: Carin A
authors.initials: CA
authors.lastname: Uyl-de Groot
authors.forename: Dimitri N M
authors.initials: DN
authors.lastname: Papatsonis
authors.forename: Bettina M C
authors.initials: BM
authors.lastname: Akerboom
authors.forename: Godfried C H
authors.initials: GC
authors.lastname: Metz
authors.forename: Henk A
authors.initials: HA
authors.lastname: Bremer
authors.forename: Aren J
authors.initials: AJ
authors.lastname: van Loon
authors.forename: Rob H
authors.initials: RH
authors.lastname: Stigter
authors.forename: Joris A M
authors.initials: JA
authors.lastname: van der Post
authors.forename: Marcel
authors.initials: M
authors.lastname: van Alphen
authors.forename: Martina
authors.initials: M
authors.lastname: Porath
authors.forename: Robbert J P
authors.initials: RJ
authors.lastname: Rijnders
authors.forename: Marc E A
authors.initials: ME
authors.lastname: Spaanderman
authors.forename: Daniela H
authors.initials: DH
authors.lastname: Schippers
authors.forename: Kitty W M
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: Kim E
authors.initials: KE
authors.lastname: Boers
authors.forename: Hubertina C J
authors.initials: HC
authors.lastname: Scheepers
authors.forename: Frans J M E
authors.initials: FJ
authors.lastname: Roumen
authors.forename: Anneke
authors.initials: A
authors.lastname: Kwee
authors.forename: Nico W E
authors.initials: NW
authors.lastname: Schuitemaker
authors.forename: Ben Willem J
authors.initials: BW
authors.lastname: Mol
authors.forename: Dick J
authors.initials: DJ
authors.lastname: van Rhenen
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Duvekot
mesh_terms: D000740:Anemia / Q000209:etiology / Q000628:therapy*; D002985:Clinical Protocols; D017707:Erythrocyte Transfusion; D005260:Female; D006801:Humans; D009426:Netherlands; D006473:Postpartum Hemorrhage; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011788:Quality of Life / Q000523:psychology*; D012107:Research Design