title: Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial.
abstract: OBJECTIVE
  To determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes.
  
  
  METHODS
  Multicentre, randomised controlled trial with prognostic stratification by hospital.
  
  
  METHODS
  20 North American and UK hospitals.
  
  
  METHODS
  5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care.
  
  
  METHODS
  Usual nursing or midwifery care or a minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position.
  
  
  METHODS
  Primary outcome was spontaneous vaginal birth. Other outcomes included intrapartum interventions, women's views of their care, and indicators of maternal and fetal health during hospital stay and 6-8 weeks after discharge.
  
  
  RESULTS
  Outcome data were obtained for 4996 women. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% confidence interval 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); odds ratio 0.67, 98.75% confidence interval 0.50 to 0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); odds ratio 0.51, 98.75% confidence interval 0.32 to 0.70. None of the other results met prespecified levels of statistical significance.
  
  
  CONCLUSIONS
  A structured approach to care in hospital labour assessment units increased satisfaction with care and was suggestive of a modest increase in the likelihood of spontaneous vaginal birth. Further study to strengthen the intervention is warranted.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN16315180.
authors.affiliation: Lawrence S Bloomberg Faculty of Nursing, University of Toronto, 155 College St, Toronto, ON, Canada, M5T 1P8. ellen.hodnett@utoronto.ca
authors.forename: Ellen D
authors.initials: ED
authors.lastname: Hodnett
authors.forename: Robyn
authors.initials: R
authors.lastname: Stremler
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
authors.forename: Julie A
authors.initials: JA
authors.lastname: Weston
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Lowe
authors.forename: Kathleen R
authors.initials: KR
authors.lastname: Simpson
authors.forename: William D
authors.initials: WD
authors.lastname: Fraser
authors.forename: Amiram
authors.initials: A
authors.lastname: Gafni