title: Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial.
abstract: OBJECTIVE
  Decreasing the prevalence of severe postpartum haemorrhages (PPH) is a major obstetrical challenge. These are often considered to be associated with substandard initial care. Strategies to increase the appropriateness of early management of PPH must be assessed. We tested the hypothesis that a multifaceted intervention aimed at increasing the translation into practice of a protocol for early management of PPH, would reduce the incidence of severe PPH.
  
  
  METHODS
  Cluster-randomised trial.
  
  
  METHODS
  106 maternity units in six French regions.
  
  
  METHODS
  Maternity units were randomly assigned to receive the intervention, or to have the protocol passively disseminated. The intervention combined outreach visits to discuss the protocol in each local context, reminders, and peer reviews of severe incidents, and was implemented in each maternity hospital by a team pairing an obstetrician and a midwife.
  
  
  METHODS
  The primary outcome was the incidence of severe PPH, defined as a composite of one or more of: transfusion, embolisation, surgical procedure, transfer to intensive care, peripartum haemoglobin decrease of 4 g/dl or more, death. The main secondary outcomes were PPH management practices.
  
  
  RESULTS
  The mean rate of severe PPH was 1.64% (SD 0.80) in the intervention units and 1.65% (SD 0.96) in control units; difference not significant. Some elements of PPH management were applied more frequently in intervention units-help from senior staff (P = 0.005), or tended to - second-line pharmacological treatment (P = 0.06), timely blood test (P = 0.09).
  
  
  CONCLUSIONS
  This educational intervention did not affect the rate of severe PPH as compared with control units, although it improved some practices.
authors.affiliation: INSERM, UMR S953, UPMC, Epidemiological Research Unit on Perinatal Health and Women's and Children's Health, Paris, France. catherine.deneux-tharaux@inserm.fr
authors.forename: C
authors.initials: C
authors.lastname: Deneux-Tharaux
authors.forename: C
authors.initials: C
authors.lastname: Dupont
authors.forename: C
authors.initials: C
authors.lastname: Colin
authors.forename: M
authors.initials: M
authors.lastname: Rabilloud
authors.forename: S
authors.initials: S
authors.lastname: Touzet
authors.forename: J
authors.initials: J
authors.lastname: Lansac
authors.forename: T
authors.initials: T
authors.lastname: Harvey
authors.forename: V
authors.initials: V
authors.lastname: Tessier
authors.forename: C
authors.initials: C
authors.lastname: Chauleur
authors.forename: G
authors.initials: G
authors.lastname: Pennehouat
authors.forename: X
authors.initials: X
authors.lastname: Morin
authors.forename: M H
authors.initials: MH
authors.lastname: Bouvier-Colle
authors.forename: R
authors.initials: R
authors.lastname: Rudigoz
mesh_terms: D002985:Clinical Protocols; D016000:Cluster Analysis; D004502:Education, Medical, Continuing; D005260:Female; D005602:France; D006771:Hospitals, Maternity; D006801:Humans; D015994:Incidence; D008880:Midwifery / Q000193:education; D009774:Obstetrics / Q000193:education; D010348:Patient Care Team; D006473:Postpartum Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D011247:Pregnancy; D011364:Professional Practice / Q000592:standards*; D018401:Sample Size; D016896:Treatment Outcome