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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 into sequentially numbered sealed opaque envelopes containing the code.
Prepared in variable random blocks stratified for parity.
Randomised when in active birth labour and met inclusion and exclusion criteria.
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: low risk of bias all women received their allocated treatment. Analysed according to intention to treat. 1 lost to follow-up;

  4. bias conclusion: moderate bias. 1 or more criteria partially met. May raise some doubt about the results
Participants Study group: n = 59.
Control group: n = 61.
Inclusion criteria: in active labour;
primiparous women with cervical dilatation of 4-7 cm;
multiparous women with cervical dilatation of 4-6 cm;
low-risk women;
read/understand English.
Exclusion criteria: poor obstetric history;
previous CS;
medical disorders;
pre-eclampsia;
multiple pregnancy;
intrauterine growth impairment;
< 36 weeks and > 42 weeks;
pyrexia;
meconium-stained liquor;
prolonged ruptured of membranes.
Interventions Study group: labour in water; water temperature 34-38 degrees Celsius; analgesia as required; exit for second stage; not out of the water for more than 30 minutes.
Control group: encouraged ambulation; if lie down use side analgesia as required.
Same midwife for all women (so 1-to-1 second stage care assumed) also same observer/assessor of pain for all
First stage study.
Outcomes Outcomes reported:
maternal outcomes;
*pain;
*use of analgesia/anaesthesia;
*augmentation of labour;
*blood pressure;
*pulse;
*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.
Additional outcomes:
studies which describe additional outcomes that may be of importance will bementioned in the text;
gestational age;
maternal age;
gravida;
parity;
cervical dilatation;
duration in tub;
meconium-stained liquor.
Notes Academic hospital, South Africa.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random list compiled in different block
size of 6 and 8 but not clear how this was
achieved or by whom
Allocation concealment (selection bias) Low risk Sequentially numbered sealed opaque envelopes containing the 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 All participants are accounted for throughout study with no withdrawals
Selective reporting (reporting bias) Low risk All outcomes mentioned in method are reports, and seem appropriate for the study and topic
Other bias Unclear risk Researcher recruited and cared for all women and provided 1-to-1 care