Yuenyong 2012.
| Methods | RCT | |
| Participants | 120 nulliparous women, aged 18 to 30 years, at least 36 weeks' gestation, singleton fetus with cephalic presentation, able and willing to have a close female relative with them during labour and birth, booked to give birth at a regional teaching hospital in Thailand | |
| Interventions | Experimental group: close female relative who attended a 2‐hour preparation class on labour routines and supportive actions, and provided continuous support during the active portion of hospital labour. The institution required that the researcher remain in order to monitor the relative's activities. Control group: usual care by health professionals, which included intermittent support. Family members were not permitted to stay with the woman | |
| Outcomes | Oxytocin during labour, analgesia, labour length, spontaneous birth, assisted vaginal birth, caesarean birth, Apgar scores, perceived control | |
| Notes | Epidural analgesia was not available and continuous EFM was not used Dates of study: November 2006 ‐ May 2007 Funding: Supported by the 90th Anniversary of Chulalongkorn University and Thailand Nursing Council Fund. Conflicts of interest: The authors report no conflict of interest or relevant financial relationships. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number sequence generated by a software program |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes were used. Envelopes were consecutively‐numbered on the outside |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participants' families, and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Research assistant blinded to group assignment collected data on satisfaction. Unclear if clinical outcome data were assessed by a researcher blinded to group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 5% lost to follow‐up: 2 in the experimental group and 4 in the control group |
| Selective reporting (reporting bias) | Low risk | Appears complete |
| Other bias | Low risk | 6 women (10%) in experimental group did not receive continuous support |
CS: caesarean section DONA: EFM: electronic fetal monitoring min: minutes NICU: neonatal intensive care unit RCT: randomised controlled trial SD: standard deviation VAS: visual analogue scale VD: vaginal delivery