Isbir 2015.
| Methods | RCT | |
| Participants | This study took place in the obstetrics clinic of a state hospital in a city located in the Middle Anatolia Region in Turkey between April and August 2014. Pregnant women at least 18 years of age, who were literate, with at least a primary school education, gestational age ≥ 37 weeks, conscious, able to communicate in Turkish, and ≥ 3 cm dilated | |
| Interventions | The intervention group (N = 36) was given routine care and continuous supportive care during labour and delivery. Supportive care was provided by 5 midwifery students from the School of Health who had taken an obstetrics course in their third year and had expressed willingness to join the study. The students were provided 24 hours of skills training directed toward continuous supportive care and practices during labour and a 2‐hour theoretical course for the research procedures that was taught by the researchers. The interventions began upon hospital admission and finished at the end of the third stage of labour. Participants in the control group (N = 36) received the routine care that was normally provided at the hospital only. At the participating hospital, pregnant women are monitored, and midwives perform the deliveries; doctors are consulted when necessary. The physical support normally offered by midwives during the first phase of labour included controlling room temperature and odours, patient positioning, and hygiene and urinary elimination | |
| Outcomes | Delivery fear (10 item scale to measure fear during delivery) during latent, active and transitional phases of labour; pain score (assessed on a 10 cm VAS ranging from 0 (no pain) to 10 (worst pain)) during latent, active and transitional phases of labour; perceived control and support in birth (SCIB subscales include internal control, external control, and support, with a total of 33 items and a 5‐point Likert scale to score responses, scale range 33 to 165, higher score associated with higher degree of perceived support and control during birth); duration of labour (hours); use of oxytocin, and caesarean section (see note) | |
| Notes | EFM not used routinely and epidural anaesthesia not available in the study hospital. Women who had in labour emergency caesarean section were excluded from both the intervention group (N = 3 excluded) and the control group (N = 6 excluded) of the study, as the investigators felt that the emergency situation interfered with supportive care, and control passed from the research and midwife team to the doctor. Caesarean section is included in this review as an outcome, calculated from the number of participants randomised to the intervention group (N = 36) and control group (N = 36), less the number of in labour emergency caesarean sections for each group Dates of study: April ‐ August 2014 Funding: not reported. Conflicts of interest: The authors declare no conflicts of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised block assignment was used to assign 72 women to the intervention group (N = 36) and the control group (N = 36). A randomised block procedure (Vickers 2006) was performed as follows: (a) a block size of 4 was selected; (b) subjects were calculated as having 6 conditions (TTCC, TCTC, CCTT, TCCT, CTCT, and CTTC); and (c) blocks were randomly selected to determine the assignment of all 72 participants, with an allocation ratio of 1:1. Predictable block size |
| Allocation concealment (selection bias) | Unclear risk | No mention of central assignment, sequential numbering or opaque envelopes or containers |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible for the woman/provider to be blinded due to the intervention, although the woman was blinded to differences between control and intervention. No mention of data analysis blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded to the group assignment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Data reported for 33/36 women in intervention and 30/36 women in control. All drop outs due to emergency caesarean section. Post randomisation exclusion |
| Selective reporting (reporting bias) | High risk | Women who underwent emergency CS were excluded from the analysis, but mode of delivery is a frequently reported outcome for labour companionship |
| Other bias | Low risk | No other bias identified |