McNiven 1996.
Methods | Randomised control, parallel trial | |
Participants | 209 low‐risk nulliparous women at 37 weeks' or more gestation recruited from a large teaching hospital in Ontario, Canada. Pregnant women who were booked for induction of labour or caesarean section were excluded. | |
Interventions | Experimental (early labour assessment) group: women received the usual assessments of fetal and maternal well‐being, such as fetal heart rate, blood pressure, and urine tests. They were also instructed when to return to the hospital. The assessment area nurse transferred women in the experimental group to the labour and delivery unit when they had progressed to the active phase of labour. Control group: direct admission to the labour and delivery unit. No instructions or advice were given regarding labour before admission to the labour ward. |
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Outcomes | Oxytocin Amniotomy Anaesthesia Percentage of caesarean deliveries percentage of instrumental deliveries Labor Agentry Scale (LAS) Length of labour Apgar at 1 min < 7 Apgar at 5 min < 7 Expectations |
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Notes | Funding source: a grant from the Perinatal Nursing Research Unit, University of Toronto, Ontario, Canada Study dates: recruitment took place from February 1994 to January 1995. Declarations of interest of trial authors: Patricia McNiven was a faculty member of the McMaster University Midwifery Education Programme and had a part‐time midwifery practice in Hamiltion; Jack Williams was a Professor at the University of Toronto and the Deputy Director‐Research, Institute for Clinical Evaluative Sciences, Toronto; Ellen Hodnett was a Professor at the University of Toronto and Heather Reisman Chair in Perinatal Nursing Research, Toronto; Karyn Kaufman was Professor and Chair of the McMaster Midwifery Education Programme, Hamilton; Mary Hannah was the Director of the University of Toronto Maternal, Infant and Reproductive Health Research Unit, Toronto, Ontario, Canada. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A random component in the sequence generation process to open numbered, sealed, and opaque envelopes sequentially. |
Allocation concealment (selection bias) | Low risk | Using sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Incomplete blinding. Investigators knew the outcome, so it was influenced. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding, and the outcome was likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 209 low‐risk nulliparous women were recruited from a large teaching hospital. 105 women were randomly allocated to the early labour assessment group and 104 to the direct admission group. |
Selective reporting (reporting bias) | Unclear risk | Not enough information provided for us to make this judgement. |
Other bias | Low risk | No apparent source of other bias. |
Abbreviations
GA: general anaesthetic NHS: National Health Service SCBU: special care baby unit