Units In England Research Articles

VP31.05: Pregnancy outcomes during the COVID‐19 pandemic: a population‐level analysis

There is conflicting international evidence regarding the effect of COVID-19 in pregnancy. We aimed to assess the effects of the COVID-19 pandemic on pregnancy outcomes. Retrospective population-level analysis using routinely collected clinical data at a large tertiary maternity unit in England. Singleton pregnancies completed beyond 16 weeks of gestation between 1 January 2016 and 31 January 2021 were included. Trends in birth weight, preterm birth, Caesarean section rate and perinatal mortality were analysed over time. Modelled COVID-19 transmission data were applied to deliveries since 1 January 2020 to assign an individual risk of COVID-19 to each pregnancy, expressed as attack rate. This was incorporated into a regression model of birth weight to account for under-ascertainment of COVID-19 cases. Asymptomatic n = 77 Mild n = 195 Moderate/Severe n = 29 43,802 pregnancies were included, with 8,343 since 1 January 2020 included in the model of birth weight. The risk of Caesarean section increased during the pandemic period (OR 1.11, 95% CI 1.03 to 1.19, p = 0.006). There was no change in the risk of stillbirth (OR 0.78, 95% CI 0.51 to 1.20, p = 0.26) or neonatal death (OR 0.89, 95% CI 0.54 to 1.47, p = 0.64). Accounting for other determinants of fetal growth there was no association between modelled COVID-19 attack rate (%) in any trimester and birth weight (first trimester p = 0.50, second p = 0.15, third p = 0.16). There was a trend towards an increase in birth weight z-score during the pandemic (Mean difference 0.04, 95% CI 0.00-0.07, p = 0.054). There was no significant change in the risk of preterm birth (OR 1.00, 95% CI 0.91-1.10, p = 0.93). We found no evidence of an overall effect of the COVID-19 pandemic on perinatal mortality or preterm birth, and in contrast to other reports there may a small increase in mean birth weight associated with the pandemic and lockdown periods. An increase in Caesarean section rate may represent a lower threshold for obstetric intervention due to COVID-19.

Associations between ethnicity and admission to intensive care among women giving birth: a cohort study.

To determine the association between ethnic group and likelihood of admission to intensive care in pregnancy and the postnatal period. Cohort study. Maternity and intensive care units in England and Wales. A total of 631 851 women who had a record of a registerable birth between 1 April 2015 and 31 March 2016 in a database used for national audit. Logistic regression analyses of linked maternity and intensive care records, with multiple imputation to account for missing data. Admission to intensive care in pregnancy or postnatal period to 6 weeks after birth. In all, 2.24 per 1000 maternities were associated with intensive care admission. Black women were more than twice as likely as women from other ethnic groups to be admitted (odds ratio [OR] 2.21, 95% CI 1.82-2.68). This association was only partially explained by demographic, lifestyle, pregnancy and birth factors (adjusted OR 1.69, 95% CI 1.37-2.09). A higher proportion of intensive care admissions in Black women were for obstetric haemorrhage than in women from other ethnic groups. Black women have an increased risk of intensive care admission that cannot be explained by demographic, health, lifestyle, pregnancy and birth factors. Clinical and policy intervention should focus on the early identification and management of severe illness, particularly obstetric haemorrhage, in Black women, in order to reduce inequalities in intensive care admission. Black women are almost twice as likely as White women to be admitted to intensive care during pregnancy and the postpartum period; this risk remains after accounting for demographic, health, lifestyle, pregnancy and birth factors.

Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks’ gestation: a propensity score matched observational study

ObjectiveTo evaluate whether in preterm neonates parenteral nutrition use in the first 7 postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important...

Functional outcomes and cost-efficiency of specialist in-patient rehabilitation following spinal cord injury: a multi-centre national cohort analysis from the UK Rehabilitation Outcomes Collaborative (UKROC)

Purpose: To evaluate functional outcomes, care needs and cost-efficiency of specialist rehabilitation for a multi-centre cohort of inpatients with spinal cord injury (SCI)-comparison based on age and aetiology. Methods and materials: Retrospective analysis of prospectively collected data from the UK Rehabilitation Outcomes Collaborative (UKROC) national clinical database from 2012-2019. Adults with SCI admitted for a rehabilitation programme in levels 1 and 2 specialist rehabilitation Units in England, were included if they had valid UK Functional Assessment Measure (UK FIM + FAM) and Northwick Park Dependency Scale (NPDS) scores recorded on admission and discharge (n = 2506 of 3321 admissions). Results: Approximately 425 patients were admitted yearly. 1344(56%) patients were under 65. 736(29%) had traumatic aetiology. Older and Traumatic SCI patients were more likely to have cervical cord damage (X 2, p < 0.001). There was a significant improvement in all parameters of functional independence (UK FIM + FAM) (p < 0.001), with the reduction in dependency and care costs (NPDS/NPCNA) (p < 0.001). 1817(72.5%) patients were discharged home. Mean care-costs savings were £25 500/year per patient. Year-on-year trends showed admissions with increasing age, higher complexity and dependency with corresponding increasing episode costs (ANOVA p < 0.001). However, the time taken to offset the cost of rehabilitation did not change significantly (ANOVA p = 0.57). Conclusions: Specialist rehabilitation services provide effective and cost-efficient rehabilitation for patients with spinal cord injury. Implications for Rehabilitation Approximately a third of patients who access specialist inpatient rehabilitation following spinal cord injury (SCI) in England are managed in the Specialist Level 1 and 2 neuro-rehabilitation units, rather than in the eight designated national SCI Centres. Despite admitting progressively more complex and dependent patients over eight years, these specialist rehabilitation units continue to provide highly cost-efficient care. The mean annual savings amount to £25,500 per patient. With a mean admission rate of 425 patients, this would generate total savings in excess of £10 million per year for the cohort. Specialist rehabilitation services play an important, but under-recognised, role in the spinal cord injury care pathway.

Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia: the PHOEBE mechanisms of action study within the PHOENIX RCT

Background Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-eclampsia, are at increased risk of long-term cardiovascular morbidity and mortality. Objectives To investigate the hypothesis that prolongation of a pregnancy affected by preterm pre-eclampsia managed by expectant management compared with planned early delivery would result in worse cardiovascular function 6 months postpartum. Design A randomised controlled trial. Setting 28 maternity hospitals in England and Wales. Participants Women who were eligible for the Pre-eclampsia in HOspital: Early iNductIon or eXpectant management (PHOENIX) study were approached and recruited for the PHOEBE study. The PHOENIX (Pre-eclampsia in HOspital: Early iNductIon or eXpectant management) study was a parallel-group, non-masked, multicentre, randomised controlled trial that was carried out in 46 maternity units across England and Wales. This study compared planned early delivery with expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia who were 34 weeks’ gestation to less than 37 weeks’ gestation and having a singleton or dichorionic diamniotic twin pregnancy. Interventions Postpartum follow-up included medical history, blood pressure assessment and echocardiography. All women had blood sampling performed on at least two time points from recruitment to the 6-month follow-up for assessment of cardiac necrosis markers. Main outcome measures Primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines then updated by 2016 guidelines, with an amended definition of diastolic dysfunction). Analyses were by intention to treat, together with a per-protocol analysis for the primary and secondary outcomes. Results Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited across 28 maternity units in England and Wales. A total of 133 women were allocated to planned delivery, 137 women were allocated to expectant management and a further 150 received non-randomised expectant management within usual care. The mean time from enrolment to delivery was 2.5 (standard deviation 1.9) days in the planned delivery group compared with 6.8 (standard deviation 5.3) days in the expectant management group. There were no differences in the primary outcome between women in the planned delivery group and those in the expectant management group using either the 2009 (risk ratio 1.06, 95% confidence interval 0.80 to 1.40) or the 2016 definition (risk ratio 0.78, 95% confidence interval 0.33 to 1.86). Overall, 10% (31/321) of women had a left ventricular ejection fraction &lt; 55% and 71% of the cohort remained hypertensive at 6 months postpartum. No differences were observed between groups in cardiorespiratory outcomes prior to discharge from hospital or in systolic or diastolic blood pressure measurements. Variables associated with the primary outcome (2009 definition) at 6 months postpartum were maternal body mass index (adjusted odds ratio 1.33 per 5 kg/m2, 95% confidence interval 1.12 to 1.59 per 5 kg/m2) and maternal age (adjusted odds ratio 2.16, 95% confidence interval 1.44 to 3.22 per 10 years). Limitations include changing definitions regarding systolic and/or diastolic dysfunction. Conclusions Preterm pre-eclampsia results in persistence of hypertension in the majority of women with late preterm pre-eclampsia at 6 months postpartum and systolic dysfunction in 10%. Pre-eclampsia should not be considered a self-limiting disease of pregnancy alone. Future work Interventions aimed at reducing cardiovascular dysfunction. Trial registration Current Controlled Trials ISRCTN01879376. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 12. See the NIHR Journals Library website for further project information.

Birthweight and patterns of postnatal weight gain in very and extremely preterm babies in England and Wales, 2008–19: a cohort study

Intrauterine and postnatal weight are widely regarded as biomarkers of fetal and neonatal wellbeing, but optimal weight gain following preterm birth is unknown. We aimed to describe changes over time in birthweight and postnatal weight gain in very and extremely preterm babies, in relation to major morbidity and healthy survival. In this cohort study, we used whole-population data from the UK National Neonatal Research Database for infants below 32 weeks gestation admitted to neonatal units in England and Wales between Jan 1, 2008, and Dec 31, 2019. We used non-linear Gaussian process to estimate monthly trends, and Bayesian multilevel regression to estimate unadjusted and adjusted coefficients. We evaluated birthweight; weight change from birth to 14 days; weight at 36 weeks postmenstrual age; associated Z scores; and longitudinal weights for babies surviving to 36 weeks postmenstrual age with and without major morbidities. We adjusted birthweight for antenatal, perinatal, and demographic variables. We additionally adjusted change in weight at 14 days and weight at 36 weeks postmenstrual age, and their Z scores, for postnatal variables. The cohort comprised 90 817 infants. Over the 12-year period, mean differences adjusted for antenatal, perinatal, demographic, and postnatal variables were 0 g (95% compatibility interval -7 to 7) for birthweight (-0·01 [-0·05 to 0·03] for change in associated Z score); 39 g (26 to 51) for change in weight from birth to 14 days (0·14 [0·08 to 0·19] for change in associated Z score); and 105 g (81 to 128) for weight at 36 weeks postmenstrual age (0·27 [0·21 to 0·33] for change in associated Z score). Greater weight at 36 weeks postmenstrual age was robust to additional adjustment for enteral nutritional intake. In babies surviving without major morbidity, weight velocity in all gestational age groups stabilised at around 34 weeks postmenstrual age at 16-25 g per day along parallel percentile lines. The birthweight of very and extremely preterm babies has remained stable over 12 years. Early postnatal weight loss has decreased, and subsequent weight gain has increased, but weight at 36 weeks postmenstrual age is consistently below birth percentile. In babies without major morbidity, weight velocity follows a consistent trajectory, offering opportunity to construct novel preterm growth curves despite lack of knowledge of optimal postnatal weight gain. UK Medical Research Council.

Observational cohort study of changing trends in non-invasive ventilation in very preterm infants and associations with clinical outcomes

ObjectiveTo determine the change in non-invasive ventilation (NIV) use over time in infants born at <32 weeks’ gestation and the associated clinical outcomes.Study designRetrospective cohort study using routinely recorded data...

'It gives you the skills of how you can cope': Exploring the self-reported experience of patients receiving in-centre haemodialysis on participating in chosen art activities.

BackgroundIncreasing numbers of patients are receiving dialysis, particularly in high‐income countries. Patients receiving haemodialysis often experience fatigue, anxiety, depression and boredom. It is suggested that arts activities could have a therapeutic effect.ObjectiveThis study aimed to explore patients' perspectives of participating while on dialysis in chosen arts and creative living activities provided by tutors at the bedside.DesignQualitative semi‐structured interviews in the interpretive tradition were conducted, with thematic analysis.Setting and ParticipantsFifteen patients of different ages, genders and ethnicities who participated in an arts activity while receiving haemodialysis in an inner‐city dialysis unit in England were included in this study.ResultsParticipants reported positive experiences of engaging in art activities. Their views on the value of the activities were grouped into five themes: diversion from receiving haemodialysis, a sense of achievement, contribution to a more positive self‐identity, increased confidence and motivation and a therapeutic talking relationship. Participants suggested that patient peer promotion of the activities could increase uptake, with patient choice of activity seen as important.ConclusionsParticipation in a chosen arts activity while receiving haemodialysis was perceived by patients to have positive psychosocial effects. We theorize three potential explanatory mechanisms for these effects: That the experience of participating in the activities engendered positive psychological states of ‘being in the flow’; enhanced self‐esteem to add to personal coping mechanisms; and offered additional facets to the patient's identity that countered the stigmatizing effect of receiving dialysis.Patient or Public ContributionPatients and public representatives advised on the design, research methods and tools.

Learning from patient safety incidents involving acutely sick adults in hospital assessment units in England and Wales: a mixed methods analysis for quality improvement.

Six per cent of hospital patients experience a patient safety incident, of which 12% result in severe/fatal outcomes. Acutely sick patients are at heightened risk. Our aim was to identify the most frequently reported incidents in acute medical units and their characteristics. Retrospective mixed methods methodology: (1) an a priori coding process, applying a multi-axial coding framework to incident reports; and, (2) a thematic interpretative analysis of reports. Patient safety incident reports (10 years, 2005-2015) collected from the National Reporting and Learning System, which receives reports from hospitals and other care settings across England and Wales. Reports describing severe harm/death in acute medical unit were identified. Incident type, contributory factors, outcomes and level of harm were identified in the included reports. During thematic analysis, themes and metathemes were synthesised to inform priorities for quality improvement. A total of 377 reports of severe harm or death were confirmed. The most common incident types were diagnostic errors (n = 79), medication-related errors (n = 61), and failures monitoring patients (n = 57). Incidents commonly stemmed from lack of active decision-making during patient admissions and communication failures between teams. Patients were at heightened risk of unsafe care during handovers and transfers of care. Metathemes included the necessity of patient self-advocacy and a lack of care coordination. This 10-year national analysis of incident reports provides recommendations to improve patient safety including: introduction of electronic prescribing and monitoring systems; forcing checklists to reduce diagnostic errors; and increased senior presence overnight and at weekends.

Temporal trends of in utero and early postnatal transfer of extremely preterm infants between 2011 and 2016: a UK population study

ObjectiveEarly postnatal transfer (PNT) of extremely preterm infants is associated with adverse outcomes compared with in utero transfer (IUT). We aimed to explore recent national trends of IUT and early...

Participatory co-design and normalisation process theory with staff and patients to implement digital ways of working into routine care: the example of electronic patient-reported outcomes in UK renal services

BackgroundSuccessful implementation of digital health systems requires contextually sensitive solutions. Working directly with system users and drawing on implementation science frameworks are both recommended. We sought to combine Normalisation Process Theory (NPT) with participatory co-design methods, to work with healthcare stakeholders to generate implementation support recommendations for a new electronic patient reported outcome measure (ePRO) in renal services. ePROs collect data on patient-reported symptom burden and illness experience overtime, requiring sustained engagement and integration into existing systems.MethodsWe identified co-design methods that could be mapped to NPT constructs to generate relevant qualitative data. Patients and staff from three renal units in England participated in empathy and process mapping activities to understand ‘coherence’ (why the ePRO should be completed) and ‘cognitive participation’ (who would be involved in collecting the ePRO). Observation of routine unit activity was completed to understand ‘collective action’ (how the collection of ePRO could integrate with service routines).ResultsThe mapping activities and observation enabled the research team to become more aware of the key needs of both staff and patients. Working within sites enabled us to consider local resources and barriers. This produced ‘core and custom’ recommendations specifying core needs that could be met with customised local solutions. We identified two over-arching themes which need to be considered when introducing new digital systems (1) That data collection is physical (electronic systems need to fit into physical spaces and routines), and (2) That data collection is intentional (system users must be convinced of the value of collecting the data).ConclusionsWe demonstrate that NPT constructs can be operationalised through participatory co-design to work with stakeholders and within settings to collaboratively produce implementation support recommendations. This enables production of contextually sensitive implementation recommendations, informed by qualitative evidence, theory, and stakeholder input. Further longitudinal evaluation is necessary to determine how successful the recommendations are in practice.

Postnatal diuretics, weight gain and home oxygen requirement in extremely preterm infants.

Diuretics are often given to infants with evolving/established bronchopulmonary dysplasia (BPD) with the hope of improving their pulmonary outcomes. We aimed to determine if diuretic use in preterm infants was associated with improved pulmonary outcomes, but poorer weight gain. An observational study over a 5year period was undertaken of all infants born at less than 29weeks of gestation and alive at discharge in all neonatal units in England who received consecutive diuretic use for at least 7days. Postnatal weight gain and home supplementary oxygen requirement were the outcomes. A literature review of randomised controlled trials (RCTs) and crossover studies was undertaken to determine if diuretic usage wasassociated with changes in lung mechanics and oxygenation, duration of supplementary oxygen and requirement for home supplementary oxygen. In the observational study, 9,457 infants survived to discharge, 44.6% received diuretics for at least 7days. Diuretic use was associated with an increased probability of supplementary home oxygen of 0.14 and an increase in weight gain of 2.5g/week. In the review, seven of the 10 studies reported improvements only in short term lung mechanics. There was conflicting evidence regarding whether diuretics resulted in short term improvements in oxygenation. Diuretic use was not associated with a reduction in requirement for supplemental oxygen on discharge. The literature review highlighted a lack of RCTs assessing meaningful long-term clinical outcomes. Randomised trials are needed to determine the long-term risk benefit ratio of chronic diuretic use.

Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching.

Therapeutic hypothermia is standard of care for babies with moderate to severe hypoxic-ischaemic encephalopathy. There is limited evidence to inform provision of nutrition during hypothermia. To assess the association during therapeutic hypothermia between (1) enteral feeding and outcomes, such as necrotising enterocolitis and (2) parenteral nutrition and outcomes, such as late-onset bloodstream infection. A retrospective cohort study using data held in the National Neonatal Research Database and applying propensity score methodology to form matched groups for analysis. NHS neonatal units in England, Wales and Scotland. Babies born at ≥ 36 gestational weeks between 1 January 2010 and 31 December 2017 who received therapeutic hypothermia for 72 hours or who died during treatment. Enteral feeding analysis - babies who were enterally fed during therapeutic hypothermia (intervention) compared with babies who received no enteral feeds during therapeutic hypothermia (control). Parenteral nutrition analysis - babies who received parenteral nutrition during therapeutic hypothermia (intervention) compared with babies who received no parenteral nutrition during therapeutic hypothermia (control). Primary outcomes were severe and pragmatically defined necrotising enterocolitis (enteral feeding analysis) and late-onset bloodstream infection (parenteral nutrition analysis). Secondary outcomes were survival at neonatal discharge, length of neonatal stay, breastfeeding at discharge, onset of breastfeeding, time to first maternal breast milk, hypoglycaemia, number of days with a central line in situ, duration of parenteral nutrition, time to full enteral feeds and growth. A total of 6030 babies received therapeutic hypothermia. Thirty-one per cent of babies received enteral feeds and 25% received parenteral nutrition. Seven babies (0.1%) were diagnosed with severe necrotising enterocolitis, and further comparative analyses were not conducted on this outcome. A total of 3236 babies were included in the matched enteral feeding analysis. Pragmatically defined necrotising enterocolitis was rare in both groups (0.5% vs. 1.1%) and was lower in babies who were fed during hypothermia (rate difference -0.5%, 95% confidence interval -1.0% to -0.1%; p = 0.03). Higher survival to discharge (96.0% vs. 90.8%, rate difference 5.2%, 95% confidence interval 3.9% to 6.6%; p < 0.001) and higher breastfeeding at discharge (54.6% vs. 46.7%, rate difference 8.0%, 95% confidence interval 5.1% to 10.8%; p < 0.001) rates were observed in enterally fed babies who also had a shorter neonatal stay (mean difference -2.2 days, 95% confidence interval -3.0 to -1.2 days). A total of 2480 babies were included in the matched parenteral nutrition analysis. Higher levels of late-onset bloodstream infection were seen in babies who received parenteral nutrition (0.3% vs. 0.9%, rate difference 0.6%, 95% confidence interval 0.1% to 1.2%; p = 0.03). Survival was lower in babies who did not receive parenteral nutrition (90.0% vs. 93.1%, rate difference 3.1%, 95% confidence interval 1.5% to 4.7%; p < 0.001). Propensity score methodology can address imbalances in observed confounders only. Residual confounding by unmeasured or poorly recorded variables cannot be ruled out. We did not analyse by type or volume of enteral or parenteral nutrition. Necrotising enterocolitis is rare in babies receiving therapeutic hypothermia, and the introduction of enteral feeding is associated with a lower risk of pragmatically defined necrotising enterocolitis and other beneficial outcomes, including rates of higher survival and breastfeeding at discharge. Receipt of parenteral nutrition during therapeutic hypothermia is associated with a higher rate of late-onset infection but lower mortality. These results support introduction of enteral feeding during therapeutic hypothermia. Randomised trials to assess parenteral nutrition during therapeutic hypothermia. Current Controlled Trials ISRCTN474042962. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 36. See the NIHR Journals Library website for further project information.

931-P: Supporting Physical Activity in Children with Type 1 Diabetes: A Survey of Health Care Professionals

Background: The risk of some of the co-morbidities associated with type 1 diabetes (T1D) can be mitigated through physical activity. Despite benefits, research shows that children and adolescents with T1D are not meeting recommended levels of physical activity. Health Care Professionals (HCPs) have an important role in supporting and encouraging children and adolescents to be physically active. Therefore it is important to understand the perspectives of HCPs in relation to understanding physical activity behaviours in children and adolescents, prior to designing interventions to support physical activity. Methods: An online mixed methods survey of HCPs in England and Wales. Respondents were asked questions about how they support physical activity in the clinic and their perceptions of barriers/enablers of physical activity. Quantitative data were analysed descriptively, qualitative data were analysed using a combined deductive framework and inductive thematic analysis using the Capability, Opportunity, Motivation model of behaviour (COM-B). Results: Responses were received from 114 individual HCPs, representing 45% of paediatric diabetes units in England and Wales. Results show that HCPs felt that the promotion of physical activity is important in their clinic (90%) and advise children and adolescents to increase levels of physical activity (88%). Many respondents (43%) felt there was lack of education opportunities for HCPs on this topic. Qualitative responses highlighted three key areas of behaviour that might be a barrier to physical activity in their patients: (1) psychological capacity (i.e., fear of hypoglycaemia and lack of understanding of how to manage insulin and glucose levels), (2) physical opportunity (i.e., time, cost, and access to resources), and (3) social opportunity (i.e., family, school, and peer support). Conclusion: This understanding will help develop future interventions to support physical activity in children and adolescents with T1D. Disclosure E. Cockcroft: None. P. Narendran: Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi. E. Wooding: None. R. C. Andrews: None. Funding National Institute for Health Research Applied Research Collaboration South West Peninsula (to E.C.)

Adherence with blood pressure self-monitoring in women with pregnancy hypertension, and comparisons to clinic readings: A secondary analysis of OPTIMUM-BP.

To assess adherence to self-monitoring of blood pressure (SMBP), and differences between SMBP and clinic readings, in a self-monitoring intervention for managing pregnancy hypertension. OPTIMUM-BP was an unmasked randomised controlled clinical trial. 154 women with pregnancy hypertension from four maternity units in England were recruited and randomised to SMBP or usual care. This secondary analysis included 91 women randomised to self-monitoring who provided BP readings. Trial instructions were for daily SMBP. Adherence was calculated as proportion of days on which SMBP readings were taken. Proportion of weeks in which at least 4 and at least 2 SMBP readings were taken was also calculated. Mean differences between clinic and SMBP measurements were calculated. Self-monitored BP data were available for 49 women with chronic hypertension and 42 women with gestational hypertension. Median percentage of days with SMBP readings was 77% (IQR 51, 89) in the chronic hypertension group and 85% (IQR 52, 95) in the gestational hypertension group. Adherence did not vary by different socio-demographic groups. Mean difference (95% CI) between clinic and SMBP for systolic BP was 0.99mmHg (-1.44, 3.41; chronic hypertension) and 3.76mmHg (0.75, 6.78; gestational hypertension) and for diastolic BP was 3.03mmHg (0.93, 5.12; chronic hypertension) and 3.27mmHg (0.56, 5.98; gestational hypertension). Adherence to self-monitoring was good and differences between SMBP and clinic readings were small. These findings offer reassurance about the use of self-monitoring at a time when it is being increasingly implemented in maternity settings.

Changes in Neonatal Admissions, Care Processes and Outcomes in England and Wales During the COVID-19 Pandemic

Background: The COVID-19 pandemic instigated multiple societal and healthcare interventions with potential to affect perinatal practice. We evaluated population-level changes in preterm and full-term admissions to neonatal units, care processes, and outcomes.Methods: We obtained information from the National Neonatal Research Database on all admissions to National Health Service neonatal units in England and Wales from 2012-2020. We evaluated admissions by gestational age, ethnicity, and Index of Multiple Deprivation, and key care processes and outcomes. We calculated the differences in numbers and rates between April-June 2020 (spring), the first three months of national lockdown and December 2019-February 2020 (winter), prior to introduction of mitigation measures (COVID period), and compared them with the corresponding differences in the seven previous years. We considered the COVID period highly unusual if the difference was smaller or larger than all previous corresponding differences, and calculated the level of confidence in this conclusion.Findings: Marked fluctuations occurred in all measures over the eight years with several highly unusual changes during the COVID period. Total admissions fell, having risen over all previous years (COVID difference: -1492; previous seven-year difference range: +100, +1617; pInterpretation: Our findings indicate substantial changes occurred in care pathways and clinical thresholds, with disproportionate effects on Black ethnic groups, during the immediate COVID-19 period, and raise the intriguing possibility that non-healthcare interventions may reduce extremely preterm births.Funding Information: Medical Research Council; Health Data Research UK.Declaration of Interests: NM reports grants outside the submitted work from the Medical Research Council, National Institute of Health Research, March of Dimes, British Heart Foundation, HCA International, Health Data Research UK, Shire Pharmaceuticals, Chiesi Pharmaceuticals, Prolacta Life Sciences, and Westminster Children’s Research Fund; NM is a member of the Nestle Scientific Advisory Board and accepts no personal remuneration for this role. NM reports travel and accommodation reimbursements from Chiesi, Nestle and Shire. All other authors report no declarations of interest.Ethics Approval Statement: The study was undertaken under approval from the Health Research Authority and Health and Care Research Wales, and with the agreement of all NHS neonatal units in England and Wales.

OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

BackgroundThe Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle’s effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle.MethodsOASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by ‘buddy’ units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle’s sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians’ adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis.DiscussionOASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle’s clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable ‘implementation blueprint’ will be produced to inform development of future guidelines to prevent perineal trauma.Trial registrationISRCTN26523605

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

ObjectiveTo assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth.MethodsPragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined.InterventionsWomen attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy.ResultsMean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds.ConclusionsThere was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking.Trial registration: Current Controlled Trials ISRCTN25260464.

Caring for critically ill adults in paediatric intensive care units in England during the COVID-19 pandemic: planning, implementation and lessons for the future

ObjectiveTo describe the experience of paediatric intensive care units (PICUs) in England that repurposed their units, equipment and staff to care for critically ill adults during the first wave of...

The effects of perineal trauma on immediate self-reported birth experience in first-time mothers

Introduction Childbirth can sometimes be stressful or traumatic, and previous research has considered how birth complications and interventions may contribute to a negative birth experience. One of the most frequent complications during birth is trauma to the perineum. The aim of this study was to investigate whether different levels of perineal trauma were associated with differences in women’s evaluation of their birth experience. Materials and methods As part of a longitudinal cohort study, the self-reported birth experiences of 202 primiparous women were compared based on the degree of perineal trauma they had experienced. Women who had given birth for the first time, vaginally and within the last 48 h in a large tertiary maternity unit in England were invited to take part. Data were collected from their hospital records with their consent and using the Childbirth Experience Questionnaire (CEQ), Experience of Birth Scale (EBS) and a perineal pain Visual Analogue Scale (VAS). Results Women with an obstetric anal sphincter injury (OASI) or episiotomy reported a more negative overall birth experience and perceived themselves as having less ability to give birth compared to those with a 1st/2nd degree sutured tear. Those with an episiotomy also reported feeling less involved in decision making processes during their birth. Significant differences remained between the OASI and 1st/2nd degree tear groups when controlling for factors known to affect birth experience, highlighting severe perineal trauma as a potential contributor to more negative birth experience. Conclusions Perineal trauma may affect a woman’s birth experience. Experiencing an episiotomy should not be overlooked as a potential contributor, especially during instrumental birth and in the absence of involved decision making. Further research is needed to disentangle the effects of episiotomy on birth experience, to explore the care needs of women with different degrees of perineal trauma and to explore how a negative birth experience may contribute to poor psychological health in the longer term.