Methods | Randomisation was computer generated, and then recorded on a list (paper copy), where the next allocation was concealed from the research until the next woman had provided consent, was recruited and thus being allocated. Methodological qualities:
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Participants | Power calculation undertaken. Water n = 58. Control n = 56. Full term, nulliparous, live, cephalic presentation, no complications, cervical dilation of 6 cm or less in established labour |
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Interventions | Control group received standard care, including cardiotocography on admission, ambulation, amniotomy and oxytocin augmentation if now cervical progress over 3 hours, intermittent auscultation during labour Intervention group as above with immersion in water when cervix had reached 6-7 cm dilated, for 60 minutes First stage of labour study, all women received 1-to-1 care from the researcher Pool was 194 litres, equipped with a heater. Water temperature ranged from 27 to 38 degrees Celsius |
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Outcomes | Pain score on 5-point behavioural scale and numerical pain score from 0 to 10, at 6-7 cm dilated and again 1 hour later In addition the following data were collected: use of augmentation, amniotic liquor conditions, duration of labour, perineal condition, gestational age, Apgar score at 1 and 5 minutes, maternal and water temperature |
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Notes | Study done in Sao Paulo, Brazil. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated random list. |
Allocation concealment (selection bias) | High risk | Each allocation on the list was covered with a tab, which was removed by the researcher after consent form signed by next participant. This description suggests the process could be open to tampering |
Blinding (performance bias and detection bias) All outcomes |
High risk | High risk of bias could have been introduced because women, carers and researcher cannot be blind to group allocation after randomisation due to the nature of the intervention |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Flow chart detailed participants from eligibility to completion; no attrition after instigation of allocated care |
Selective reporting (reporting bias) | Low risk | All the data mentioned in the methods, and that would reasonably be expected of this study are reported |
Other bias | Unclear risk | All women had 1-to-1 care,which is known to affect outcomes, but is common for water immersion care. In this study the care was from the researcher, regardless of group |