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. Author manuscript; available in PMC: 2014 Apr 10.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD000111. doi: 10.1002/14651858.CD000111.pub3
Methods Randomisation by sealed opaque, sequentially numbered envelopes that were kept in the admission ward. Prepared in random blocks of 10, stratified for parity.
Methodological qualities:

  1. selection bias: none;

  2. performance bias: high risk of bias could have been introduced because researcher cannot be blind to group allocation after randomisation;

  3. exclusion bias: high risk of bias 37/134 of women allocated to bath group did not bathe and 34/134 of women allocated to the control group did bathe. Analysed according to intention to treat;

  4. bias conclusion: high risk of bias, where 1 or more criteria are not met may cause plausible bias that seriously weakens confidence in the results
Participants Study group n = 137. Control group n = 137.
Inclusion criteria:
gestation > 36 weeks;
low risk;
singleton;
cephalic presentation.
Exclusion criteria: planned CS; history of Group B streptococcal infection; epidural anaesthesia; continuous FHR monitoring needed
Interventions Women were allocated to a delivery suite with a bath or to a general delivery suite without a bath. The bath group was allowed to use the bath as long as each woman wished, but they had to get out during second stage of labour (first stage only). The bath tub was 120 cm × 160 cm × 54 cm and the maximum water temperature was 37 degrees Celsius.
Control group was allowed to use a shower.
First stage only study women received care from same midwives but no mention of 1-to-1 second care or not
Outcomes Maternal outcomes:
*maternal experience and satisfaction of labour;
*use of analgesia/anaesthesia;
*augmentation of labour;
*presence of meconium-stained liquor;
*duration of labour and birth;
*mode of delivery;
*trauma to the birth canal requiring suturing;
*blood loss;
*postpartum depression;
breastfeeding.
Fetal outcomes:
*abnormal FHR patterns, needing intervention.
Neonatal outcomes:
*neonatal condition;
*admittance to NICU or high dependency care unit;
* temperature at birth;
*neonatal infection rates.
Notes Tertiary referral hospital in Adelaide, Australia. May 1995 - Sept 1998.
Some of the results are not in an appropriate format. Further information needed
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Random table of numbers, using variable blocks of 10, by a clerk independent of the study. Stratification was by place of birth, hospital or midwifery birth centre
Allocation concealment (selection bias) Low risk On recruitment midwife telephoned an independent clerk for 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. Study says where appropriate the data analyst was blinded to group; however bias is likely to be at point of care
Incomplete outcome data (attrition bias)
All outcomes		 Low risk Data analysed on intention-to-treat basis. Flow chart reports on participants from eligibility to completion. From randomisation similar numbers (water 58 (42%)/control 53 (39%)) became ineligible or did not use the allocated care option as might be expected in a study of this size which respected women’s right to choice care options; however, this is a high percentage
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 No mention of 1-to-1 care or not, but no other issue apparent