| Methods | Randomisation by sealed opaque, sequentially numbered envelopes containing the code. Methodological qualities:
|
|
| Participants | Group 1: n = 100: the “early bath group”. Group 2: n = 100: the “late bath group”. Regional referral hospital in the west of Sweden. Inclusion criteria: gestation > 34 weeks; low risk; singleton; cephalic presentation; spontaneous labour; contractions 3/10 minutes and/or ruptured membranes with cervical dilatation less than 3 cm. Normal FHR pattern. Ambulation and analgesics were allowed. |
|
| Interventions | All women used an oval tub that was 1.5 m long and 40 cm deep. It contained 300 L of waters at a temperature not more than 38 degrees Celsius. Group 1: the “early bath group” had a cervical dilatation of less than 5 cm when immersed in water. Group 2: the “late bath group” had a cervical dilation of 5 cm or more when immersed in water No mention of 1-to-1 care or not. |
|
| Outcomes | Maternal outcomes: *use of analgesia/anaesthesia; *augmentation of labour; duration of labour and birth; *mode of delivery; *maternal infection; *abnormal FHR patterns needing intervention; *neonatal condition; *admittance to NICU or high dependency care unit; *neonatal infection rates (studies that describe additional outcomes that may be of importance will be mentioned in the text); parity; maternal age; birthweight; Bishop score before randomisation. |
|
| Notes | Duration of labour not in acceptable format. Early group 9.80 hours and late group 8. 48 hours P < 0.004. Primipara: 72/100 in early group and 60/100 in late group. Maternal mean age: 26.3 early group; 27.2 late group. Mean birthweight: 3550 g early group; 3616 g late group. Performance bias: caregivers were not blind to group allocation. Not recorded if results were analysed blind. Exclusion bias: *women did not enter bath - groups not mentioned. Thus moderate rate of bias may be present. |
|
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated. |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes containing allocation. |
| 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 | 1 woman in early bath group did not use water, compared to 7 in late bath group; however, this might be expected as a result of different degrees of progression in labour |
| Selective reporting (reporting bias) | Low risk | All outcomes identified in methods are reported. |
| Other bias | Unclear risk | Percentage of primigravida higher in early group, but likely to be due to chance No mention of 1-to-1 care or not. |