Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial.

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.

Design: Multicentre, randomised controlled trial with prognostic stratification by hospital.

Setting: 20 North American and UK hospitals.

Participants: 5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care.

Interventions: 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.

Main Outcome Measures: 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.

Conclusion: 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.

Trial Registration: Current Controlled Trials ISRCTN16315180.