Gagnon 1997.
| Methods | RCT | |
| Participants | 413 women admitted to an intrapartum unit at a tertiary care teaching hospital in Montreal, Canada, were randomly allocated to experimental (N = 209) or control (N = 204) groups. All but 3 in the experimental group and 6 in the control group were accompanied by a spouse, relative or friend during labour. All participants were nulliparous, with singleton fetuses, > 37 weeks' gestation, and in labour | |
| Interventions | Experimental: One‐to‐one nursing care from randomisation until 1 hour post birth. Care was provided by on‐call nurses who were hired specifically for the study and had received a 30‐hour training program and quarterly refresher workshops. The training program included critical reviews of the literature concerning the effects of intrapartum medical and nursing practices, as well as discussions of stress and pain management techniques. The nurse provided the usual nursing care plus physical comfort, emotional support, and instruction on relaxation and coping techniques. The nurse took meal breaks and brief rest breaks. Women in the comparison group received usual nursing care by the regular unit staff, consisting of intermittent support and monitoring |
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| Outcomes | Caesarean birth, caesarean birth for cephalopelvic disproportion or failure to progress, post‐randomisation artificial oxytocin augmentation, post‐randomisation analgesia/anaesthesia, instrumental vaginal delivery (forceps or vacuum extraction), NICU admission, perineal trauma, mean duration of labour post‐randomisation, postpartum urinary catheterisation | |
| Notes | The participants had been admitted to the unit for an average of 5 hours (SD = 4 hours) prior to randomisation. 36 women in the experimental group and 41 in the control group had epidural analgesia prior to randomisation. 55 women in the experimental group and 45 in the control group had intravenous oxytocin augmentation of labour prior to randomisation. Mean duration of labour post‐randomisation was 9.2 hours (SD = 4.3). Epidural analgesia was available but it was not stated if EFM was used routinely Dates of study: not clear Funding: This project was supported by the Fonds de la recherche en sante' du Que'bec (FRSQ), a research funding agency of the government of Quebec, Montreal, Quebec, Canada. Conflicts of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomized using a list of computer generated random numbers." |
| Allocation concealment (selection bias) | Low risk | "Randomized in blocks of eight... Group assignments were placed in sequentially numbered, sealed, opaque envelopes." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participants' family members, and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome data not collected by clinical staff, self‐administered questionnaires were used, and data collectors reviewed nurses' notes after "most" other data from medical records was collected |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |