Woodward 2004.
| Methods | Randomisation schedule provided by National Perinatal Epidemiology Unit, Oxford. A person unconnected to study prepared by consecutively numbered, computer‐generated random allocation in sealed opaque envelopes.
Methodological qualities:
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| Participants | 2 groups in RCT part of study. Water n = 40 Land n = 20 (2:1 ratio as about local experience was 50% of women choose not to use water). Women recruited through community midwife, posters in clinics, and media promotions and interested women contacted researcher or gave permission to own midwife to pass on information. Aged 18‐50 Low risk |
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| Interventions | Immersion in water during first and second stages of labour. Results do not distinguish which of the women allocated to pool, did not use pool (16 of 40 women), used pool for first stage only (13 of 40 women), used pool in second stage but not for birth (1 woman), or gave birth in the pool (10 women) (no subgroup analysis). Data entered into both 'immersion in water versus no immersion during first stage of labour ' AND 'immersion in water versus no immersion during second stage of labour' DATA and ANALYSIS section. Waterbirth pool ‐ dimensions/volume not described, temperature described as recorded but data not provided. No mention of 1‐to‐1 care or not. |
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| Outcomes | ITT analysis done. Maternal: age, social history, pulse, temperature, maternal satisfaction on scale of 0‐6 immediately post birth and in 6 week postal questionnaire. Labour: length of first, second stages; analgesia used; augmentation; mode of birth. Fetus/neonate: cord arterial and venous gases, Apgar score at 1, 5 and 10 mins, time to first respiration, rectal temperature at birth, ear swabs, method of feeding, date and time of first feed, admission to neonatal unit (plus any interventions needed) infection, any mortality/morbidity. Water; duration in water, water temperature, microbiological analysis at end of labour/use. |
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| Notes | Non‐randomised, preference arm data not included although additional 20 participants in this part of study. 16 (40%) of water women did not use water. UK study. Dates of trial: not reported Funding: partly funded by Getting Started in Research Grant from Northampton General Hospital NHS Trust. Declaration of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated independent of study |
| Allocation concealment (selection bias) | Low risk | Consecutively numbered in sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | High risk of bias could have been introduced because women, carers and researcher could not be blind to group allocation after randomisation due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | All participants are accounted for throughout study with no withdrawals, however many did not receive the allocated intervention |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned in method are reported, and seem appropriate for the study and topic |
| Other bias | Unclear risk | 40% or water group did not use water, which is consistent with choice and other papers on this topic |
*: prespecified outcomes CS: caesarean section FHR: fetal heart rate ITT: intention‐to‐treat KH: Karlskrona Hospital LH: Lund hospital NICU: neonatal intensive care unit OH: Osterund Hospital OP: Occipito posterior VBAC: vaginal birth after caesarean section