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Safety and effectiveness of COVID-19 vaccines during pregnancy is a particular concern affecting vaccination uptake by this vulnerable group. Here we evaluated evidence from 23 studies including 117,552 COVID-19 vaccinated pregnant people, almost exclusively with mRNA vaccines. We show that the effectiveness of mRNA vaccination against RT-PCR confirmed SARS-CoV-2 infection 7 days after second dose was 89·5% (95% CI 69·0-96·4%, 18,828 vaccinated pregnant people, I 2  = 73·9%). The risk of stillbirth was significantly lower in the vaccinated cohort by 15% (pooled OR 0·85; 95% CI 0·73–0·99, 66,067 vaccinated vs. 424,624 unvaccinated, I 2  = 93·9%). There was no evidence of a higher risk of adverse outcomes including miscarriage, earlier gestation at birth, placental abruption, pulmonary embolism, postpartum haemorrhage, maternal death, intensive care unit admission, lower birthweight Z-score, or neonatal intensive care unit admission ( p  > 0.05 for all). COVID-19 mRNA vaccination in pregnancy appears to be safe and is associated with a reduction in stillbirth. Pregnant women have been disproportionately under-vaccinated against COVID-19, partly because they were excluded from initial trials. This systematic review and meta-analysis supports efficacy of vaccination in pregnancy, and finds no evidence of adverse maternal or perinatal outcomes.

To determine the cost-utility of a multi-professional simulation training programme for obstetric emergencies-Practical Obstetric Multi-Professional Training (PROMPT)-with a particular focus on its impact on permanent obstetric brachial plexus injuries (OBPIs). A model-based cost-utility analysis. Maternity units in England. Simulated cohorts of individuals affected by permanent OBPIs. A decision tree model was developed to estimate the cost-utility of adopting annual, PROMPT training (scenario 1a) or standalone shoulder dystocia training (scenario 1b) in all maternity units in England compared to current practice, where only a proportion of English units use the training programme (scenario 2). The time horizon was 30 years and the analysis was conducted from an English National Health Service (NHS) and Personal Social Services perspective. A probabilistic sensitivity analysis was performed to account for uncertainties in the model parameters. Outcomes for the entire simulated period included the following: total costs for PROMPT or shoulder dystocia training (including costs of OBPIs), number of OBPIs averted, number of affected adult/parental/dyadic quality adjusted life years (QALYs) gained and the incremental cost per QALY gained. Nationwide PROMPT or shoulder dystocia training conferred significant savings (in excess of £1 billion ($1.5 billion)) compared to current practice, resulting in cost-savings of at least £1 million ($1.5 million) per any type of QALY gained. The probabilistic sensitivity analysis demonstrated similar findings. In this model, national implementation of multi-professional simulation training for obstetric emergencies (or standalone shoulder dystocia training) in England appeared to both be cost-saving when evaluating their impact on permanent OBPIs.

ObjectivesSuboptimal intrapartum electronic fetal heart rate monitoring using cardiotocography has remained a persistent problem (EFM-CTG). We aimed to identify the range of influences on the safety of using EFM-CTG in practice.DesignScoping review to identify influences related to the practice of intrapartum EFM.Data sourcesMEDLINE, Embase, CINAHL, Web of Science, Scopus, British Nursing Index, Cochrane Library, from 1 January 2001 to 25 August 2024, and grey literature.Eligibility criteriaArticles that reported potential influences on the clinical practice of intrapartum EFM-CTG in hospital-based intrapartum maternity care settings, including primary studies, secondary analyses, reviews, reports, conference abstracts and investigations relevant to maternity and obstetrics, in English. Evaluations of technological modifications to traditional EFM-CTG monitoring and analysis were excluded.Data extraction and synthesisWe extracted influences on EFM-CTG from the included studies. Findings were synthesised using a best-fit framework approach, structured using an existing 19-domain framework of contributory factors for patient safety incidents in hospitals.Results142 articles and 14 reports were included. Our synthesis identified influences on EFM practice across all 19 domains of the contributory factors framework, including those relating to cognitive, social and organisational factors and interactions between professional work and tools used for fetal monitoring.ConclusionReducing avoidable harm associated with electronic fetal monitoring requires a systems approach based on a sound understanding of the full range of influences on practice.

In Zimbabwe, many health facilities are not able to manage serious obstetric complications. Staff most commonly identified inadequate training as the greatest barrier to preventing avoidable maternal deaths. We established an onsite obstetric emergencies training programme for maternity staff in the Mpilo Central Hospital. We trained 12 local staff to become trainers and provided them with the equipment and resources needed for the course. The trainers held one-day courses for 299 staff at the hospital. Maternal mortality in Zimbabwe has increased from 555 to 960 per 100,000 pregnant women from 2006 to 2011 and 47% of the deaths are believed to be avoidable. Most obstetric emergencies trainings are held off-site, away from the clinical area, for a limited number of staff. Following an in-hospital train-the-trainers course, 90% (138/153) of maternity staff were trained locally within the first year, with 299 hospital staff trained to date. Local system changes included: the introduction of a labour ward board, emergency boxes, colour-coded early warning observation charts and a maternity dashboard. In this hospital, these changes have been associated with a 34% reduction in hospital maternal mortality from 67 maternal deaths per 9078 births (0.74%) in 2011 compared with 48 maternal deaths per 9884 births (0.49%) in 2014. Introducing obstetric emergencies training and tools was feasible onsite, improved clinical practice, was sustained by local staff and associated with improved clinical outcomes. Further work to study the implementation and effect of this intervention at scale is required.

ObjectiveIn the UK and worldwide, there are substantial ethnic inequalities in maternal and perinatal care and outcomes. We aim to assess the impact of the unprecedented change in care provision during the COVID-19 pandemic on inequalities in adverse maternity outcomes.DesignRetrospective cohort study using structured electronic health record data.SettingEnglish hospital trusts providing maternity care.ParticipantsWomen giving birth and babies born in the National Health Service (NHS) in England between 1 April 2018 and 31 March 2021, in three time groups: prepandemic, the first pandemic wave (26 March 2020 to 30 June 2020) and second pandemic wave (1 July 2020 to 31 March 2021). Self-reported ethnicity was grouped into White, South-Asian, Black, Mixed and Other.Main outcome measuresComposite and component measures of maternal (emergency caesarean section, obstetric anal sphincter injury, hysterectomy, sepsis, anaesthetic complications and prolonged hospital stay) and perinatal (stillbirth, neonatal death, preterm birth, brain injury, small for gestational age and prolonged hospital stay). Poisson regression was used to compare relative risks between different ethnic groups.Findings1.54 million maternal and 1.43 million neonatal records were included. The overall incidence of adverse outcomes per 1000 births initially decreased maternal: from 308.0 (95% CI 307.0 to 309.0) to 291.0 (95% CI 311.4 to 314.9) (p<0.001); perinatal: from 133.0 (95% CI 132.3 to 133.7) to 111.9 (95% CI 110.1 to 113.7) (p<0.001)), but then increased in the second pandemic period (maternal: 313.2 (95% CI 311.4 to 314.9) (p<0.001); perinatal 118.9 (95% CI 117.7 to 120.0) (p<0.001)). The risk of adverse outcomes was higher in women and babies from all ethnic minority groups compared with White women in both pandemic periods. Black and South-Asian women and babies were approximately 25% more likely to sustain adverse outcomes. While similar overall changes in adverse outcomes were seen in all groups, existing inequalities were sustained throughout the pandemic periods.InterpretationExisting inequalities in adverse maternal and perinatal/neonatal outcomes were maintained, not tempered, during the pandemic, despite substantial changes to maternity services and care. Further research on possible interventions to reduce inequality is needed.

ObjectivesDetecting and responding to deterioration of a baby during labour is likely to benefit from a standardised approach supported by principles of track-and-trigger systems. To inform co-design of a standardised approach and associated implementation strategies, we sought the views of UK-based maternity professionals.DesignTwo successive cross-sectional surveys were hosted on an online collaboration platform (Thiscovery) between July 2021 and April 2022.SettingUK.ParticipantsAcross both surveys, 765 UK-based maternity professionals.Primary and secondary outcome measuresCount and percentage of participants selecting closed-ended response options, and categorisation and counting of free-text responses.ResultsMore than 90% of participants supported the principle of a standardised approach that systematically considers a range of intrapartum risk factors alongside fetal heart rate features. Over 80% of participants agreed on the importance of a proposed set of evidence-based risk factors underpinning such an approach, but many (over 75%) also indicated a need to clarify the clinical definitions of the proposed risk factors. A need for clarity was also suggested by participants’ widely varying views on thresholds for actions of the proposed risk factors, particularly for meconium-stained liquor, rise in baseline fetal heart rate and changes in fetal heart rate variability. Most participants (>75%) considered a range of resources to support good practice as very useful when implementing the approach, such as when and how to escalate in different situations (82%), how to create a supportive culture (79%) and effective communication and decision-making with those in labour and their partners (75%).ConclusionsWe found strong professional support for the principle of a standardised approach to detection and response to intrapartum fetal deterioration and high agreement on the clinical importance of a set of evidence-based risk factors. Further work is needed to address: (1) clarity of clinical definitions of some risk factors, (2) building evidence and agreement on thresholds for action and (3) deimplementation strategies for existing local practices.

ObjectiveTo investigate women’s experiences of having a birth assisted by the Odon Device (an innovative device for assisted vaginal birth) and participation in intrapartum research.DesignQualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study.SettingA tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019.ParticipantsEight women, four operators and 11 midwives participated with eight observations of the assisted vaginal birth, eight interviews with women in the postnatal period, 39 interviews/reflections with operators and 19 interviews with midwives. Women in the case study research were recruited from participants in the main ASSIST Study.InterventionThe Odon Device, an innovative device for assisted vaginal birth.ResultsThirty-nine case studies were undertaken. Triangulation of data sources (participant observation, interviews with women, operators and midwives) enabled the exploration of women’s experiences of the Odon Device and recruitment in the intrapartum trial. Experiences were overwhelmingly positive. Women were motivated to take part by a wish for a kinder birth, and because they perceived both the recruitment and research processes (including observation) to be highly acceptable, regardless of whether the Odon-assisted birth was successful or not.ConclusionsInterviews and observations from multiple stakeholders enabled insight into women’s experiences of an innovative device for assisted vaginal birth. Applying these qualitative methods more broadly may illuminate perspectives of key stakeholders in future intrapartum intervention research and beyond.Trial registration numberISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.

ObjectiveWhen novel devices are used ‘in human’ for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.DesignWe undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each ‘case’ was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.SettingTertiary referral National Health Service maternity unit in the Southwest of England.ParticipantsWomen requiring a clinically indicated assisted vaginal birth.InterventionThe Odon Device, an innovative device for assisted vaginal birth.Primary and secondary outcome measuresDetermining the optimal device technique, device design and defining clinical parameters for use.ResultsThirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.ConclusionsCase study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice.Trial registration numberISRCTN10203171.

Background Assisted vaginal birth is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for assisted vaginal birth (forceps and ventouse) are often not utilised in settings where there is most clinical need, resulting in maternal and neonatal morbidity and mortality which could have been prevented. The BD Odon Device is a new device for assisted vaginal birth that may be able to address this unmet need. However, before dissemination, the device requires evaluation in robust clinical trials. A feasibility study to investigate the clinical impact, safety, and acceptability of the BD Odon Device for assisted vaginal birth is therefore planned. This will provide further information on acceptability, recruitment, and the outcome data required to design a future randomised controlled trial of the BD Odon Device versus Kiwi ventouse. Methods Forty women who require an assisted vaginal birth for a recognised clinical indication will have the birth assisted with the BD Odon Device. The primary outcome is successful vaginal birth completed with the BD Odon Device. Secondary clinical outcomes include maternal and neonatal outcomes, and maternal and practitioner satisfaction. Safety data will be reviewed following every birth. Discussion A future randomised controlled trial of the BD Odon Device versus the current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the randomised controlled trial design. Trial registration ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018.

Background Disparities in stillbirth and preterm birth persist even after correction for ethnicity and social deprivation, demonstrating that there is wide geographical variation in the quality of care. To address this inequity, Tommy’s National Centre for Maternity Improvement developed the Tommy’s Clinical Decision Tool, which aims to support the provision of “the right care at the right time”, personalising risk assessment and care according to best evidence. This web-based clinical decision tool assesses the risk of preterm birth and placental dysfunction more accurately than current methods, and recommends best evidenced-based care pathways in a format accessible to both women and healthcare professionals. It also provides links to reliable sources of pregnancy information for women. The aim of this study is to evaluate implementation of Tommy’s Clinical Decision Tool in four early-adopter UK maternity services, to inform wider scale-up. Methods The Tommy’s Clinical Decision Tool has been developed involving maternity service users and healthcare professionals in partnership. This mixed-methods study will evaluate: maternity service user and provider acceptability and experience; barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences. Data will be gathered over 25 months through interviews, focus groups, questionnaires and through the Tommy’s Clinical Decision Tool itself. The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) will inform data analysis. Discussion This paper describes the intervention, Tommy’s Clinical Decision Tool, according to TiDIER guidelines, and the protocol for the early adopter implementation evaluation study. Findings will inform future scale up. Trial registration This study was prospectively registered on the ISRCTN registry no. 13498237 , on 31 st January 2022.