Source of data and study population
This study used data from the Birthplace in England national prospective cohort study, which was designed to compare perinatal and maternal outcomes and interventions by planned place of birth at the start of care in labour in England [12].
The cohort study methods are described in full elsewhere [8, 12]. Briefly, the Birthplace cohort included a total of 79,774 births between April 2008 and April 2010, including 32,257 planned OU births from a stratified random sample of 36 OUs, 11,666 planned births in 53 freestanding midwifery units (FMUs), 17,582 planned births in 43 alongside midwifery units (AMUs) and 18,269 planned home births from 142 NHS trusts across England. Births were eligible for inclusion if the woman was planning a vaginal birth and received some labour care from an NHS midwife in her planned birth setting. Women who had an elective caesarean section or caesarean section before the onset of labour, presented in preterm labour (<37 weeks’ gestation), had a multiple pregnancy, or who were “unbooked” (received no antenatal care) or had an unplanned home birth were excluded. Stillbirths occurring before the start of care in labour were excluded. Women were defined as ‘low risk’ if, prior to the onset of labour, they were not known to have any of the medical or obstetric risk factors listed in the NICE intrapartum guidelines [13].
Data were recorded by the midwife attending the birth using a study-specific data collection form started during labour and completed on or after the fifth postnatal day. Where a woman transferred to another unit, the form transferred with the woman and data collection was continued in the receiving unit. Data collected for all women included maternal characteristics, medical or obstetric risk factors known prior to the onset of labour, complicating conditions identified by the midwife at the start of care in labour, whether the woman used immersion in water for pain relief at any time during labour, obstetric interventions, including labour augmentation with oxytocin, epidural or spinal analgesia, forceps or ventouse delivery, intrapartum caesarean section, and maternal and neonatal outcomes, including 3rd/4th degree tear and blood transfusion for the mother and Apgar score at 5 minutes and admission to a neonatal unit for the baby. Where a woman was transferred during labour or immediately after the birth, information was recorded about the primary reason for transfer and about the timing of the transfer, including the time of the decision to transfer and the time that the transfer started.
Information was not collected about the urgency of the transfers so we used an approach adopted for another study [14] to classify transfers as being for ‘potentially urgent reasons’ when the primary reason for transfer was antepartum haemorrhage, failure to progress in the second stage and fetal distress in the first or second stage. This method of classification identifies women with an increased risk of instrumental delivery, caesarean section or adverse neonatal outcome within an hour of arrival in the OU [14].
The study population for the analyses reported here was ‘low risk’ nulliparous women in the Birthplace cohort with a term pregnancy (37-42+0 weeks’ gestation) who planned to give birth in a non-obstetric unit setting and who did not have ‘complicating conditions’ at the start of labour care that might either contraindicate immersion in water or be a reason for transfer to an obstetric unit [11]. Women with the following ‘complicating conditions’ noted by the midwife at the start of care in labour were excluded: meconium stained liquor, prolonged rupture of membranes (>18 hours), hypertension (diastolic ≥90 mmHg more than once, 20 min. apart, and ≥100 mmHg once of systolic ≥ 160 mmHg at least once), abnormal vaginal bleeding, abnormal fetal heart rate, or non-cephalic presentation. Finally, we excluded women with missing data on use of water immersion to relieve labour pain.
Outcomes
The main outcomes were:
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Intrapartum transfer before birth
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Intrapartum caesarean section
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Straightforward vaginal birth, defined as birth without forceps, ventouse or caesarean, with no 3rd or 4th degree tear and no blood transfusion.
Secondary outcomes were:
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Transfer for failure to progress in the first stage of labour
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Transfer before birth for ‘potentially urgent reasons’
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Transfer for pain relief or epidural analgesia
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Augmentation in labour with oxytocin
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Epidural or spinal analgesia
Statistical analysis
To assess the association between immersion in water for pain relief and our outcome measures we used log Poisson regression to calculate relative risks (RR) and 95% confidence intervals (CI), both unadjusted and adjusted for maternal characteristics (maternal age, ethnic group, understanding of English, marital or partner status, index of multiple deprivation (IMD) score [15], and gestational age at birth). Analyses were performed separately for each type of birth setting. As in previous analyses of the Birthplace cohort, probability weights were used to adjust for the varying duration of each unit or trust’s participation in the study and robust variance estimation was used to allow for the clustered nature of the data within maternity units and NHS trusts (for home births). For each outcome, we report the number of events, the number of births, the weighted incidence and the unadjusted and adjusted relative risks. For completeness, we also estimated the unadjusted relative risks restricted to births included in the adjusted analysis, but because there was a low level of missing data this had a minimal effect on the estimated RRs and CIs so these are not reported. Women not using immersion in water for pain relief were the reference category in all analyses. To assess whether the associations between immersion in water for pain relief and our main outcomes differed by planned place of birth, a Wald test for statistical interaction was performed. Where the interaction was not significant at the 5% level, an analysis to estimate the effect of water immersion adjusting for the effect of planned place of birth, but ignoring the interaction between planned place of birth and water immersion, was conducted.
Post protocol we decided to perform two additional statistical analyses. First, because transfer, or birth occurring soon after the start of care in labour might reduce a woman’s opportunity to use immersion in water, and this could potentially confound the relationship between immersion in water and our study outcomes, we carried out a sensitivity analysis in which we repeated the main analysis, but excluded women for whom the decision to transfer was taken within the first 90 minutes after the start of labour care, who gave birth within 90 minutes, or where the timing of either of these events was unknown. Second, to check that there were no obvious adverse effects on neonatal outcomes associated with immersion in water for pain relief, we estimated the weighted proportion, and unadjusted and adjusted relative risks of Apgar score below 7 at 5 minutes and neonatal admission, by planned place of birth for women who did and did not use immersion in water for pain relief. Stata version 11.2 was used for all analyses [16].
Ethical approval
Research ethics committee approval for the Birthplace study was obtained from the Berkshire Research Ethics Committee and did not require consent to be sought from participants as no personally identifiable data were collected (MREC ref 07/H0505/151).
