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Objective: Assisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs.Study Design: Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers.Results: Of 4098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20 (55%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers (64%). Only eight (21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25 (64%) papers.Conclusions: Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required. [ABSTRACT FROM AUTHOR]

Background: Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements - the changes that need to be made in a healthcare process - remains a key question. Methods for doing so collaboratively, rapidly and remotely offer much potential, but are under-developed. We propose an approach for engaging diverse stakeholders remotely in a consensus-building exercise to help specify improvements in a healthcare process, and we illustrate the approach in a case study.Methods: Organised in a five-step framework, our proposed approach is informed by a participatory ethos, crowdsourcing and consensus-building methods: (1) define scope and objective of the process improvement; (2) produce a draft or prototype of the proposed process improvement specification; (3) identify participant recruitment strategy; (4) design and conduct a remote consensus-building exercise; (5) produce a final specification of the process improvement in light of learning from the exercise. We tested the approach in a case study that sought to specify process improvements for the management of obstetric emergencies during the COVID-19 pandemic. We used a brief video showing a process for managing a post-partum haemorrhage in women with COVID-19 to elicit recommendations on how the process could be improved. Two Delphi rounds were then conducted to reach consensus.Results: We gathered views from 105 participants, with a background in maternity care (n = 36), infection prevention and control (n = 17), or human factors (n = 52). The participants initially generated 818 recommendations for how to improve the process illustrated in the video, which we synthesised into a set of 22 recommendations. The consensus-building exercise yielded a final set of 16 recommendations. These were used to inform the specification of process improvements for managing the obstetric emergency and develop supporting resources, including an updated video.Conclusions: The proposed methodological approach enabled the expertise and ingenuity of diverse stakeholders to be captured and mobilised to specify process improvements in an area of pressing service need. This approach has the potential to address current challenges in process improvement, but will require further evaluation. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of type of bariatric surgery on pregnancy outcomes.Study Design: This is a national prospective observational study using the UK Obstetric Surveillance System (UKOSS). Data collection was undertaken in 200 consultant-led NHS maternity units between November 2011 and October 2012 (gastric banding), and April 2014 and March 2016 (gastric bypass and sleeve gastrectomy). Participants were pregnant women following gastric banding (n = 127), gastric bypass (n = 134) and sleeve gastrectomy (n = 29). Maternal and perinatal outcomes were compared using generalised linear and linear mixed models. Maternal outcomes included gestational weight gain, pre-eclampsia, gestational diabetes, anaemia, surgical complications. Perinatal outcomes included birthweight, small/large for gestational age (SGA/LGA), preterm birth, stillbirth.Results: Maternal: Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of anaemia compared with gastric bypass (banding (16 %) vs bypass (39 %): p = 0.002, sleeve (21 %) vs bypass: p = 0.04). Gestational diabetes risk was lower after gastric banding compared with gastric bypass (7 % vs 16 %, p = 0.03) despite women with banding having significantly greater weight at booking as well as gestational weight gain. Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of surgical complications than after gastric bypass (banding (0.9 %) vs bypass (11.4 %): p = 0.03, sleeve (0.0 %) vs bypass: p = 0.06). Perinatal: Infants born to mothers after gastric banding had a higher birthweight than those born to mothers after gastric bypass (mean difference = 260 g (125-395), p < 0.001). Infants were more likely to be LGA if their mothers had gastric banding compared with gastric bypass or sleeve gastrectomy (banding (21 %) vs bypass (5 %): p = 0.006; banding vs sleeve (3 %): p = 0.03). Risk of preterm birth was higher in women with gastric banding compared with gastric bypass (13 % vs 8 %, p = 0.04).Conclusions: Women planning bariatric surgery should be counselled regarding the differing impacts of different types of procedure on any future pregnancy. Pre-existing gastric bypass is associated with higher rates of potentially serious surgical complications during pregnancy. [ABSTRACT FROM AUTHOR]

Objective: 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). Design: A model-based cost-utility analysis. Setting: Maternity units in England. Population: Simulated cohorts of individuals affected by permanent OBPIs. Methods: 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. Main outcome measures: 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. Results: 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. Conclusion: 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. [ABSTRACT FROM AUTHOR]

Abstract Maternity care continues to be associated with avoidable harm that can result in serious disability and profound anguish for women, their children, and their families, and in high costs for healthcare systems. As in other areas of healthcare, improvement efforts have typically focused either on implementing and evaluating specific interventions, or on identifying the contextual features that may be generative of safety (e.g. structures, processes, behaviour, practices, and values), but the dialogue between these two approaches has remained limited. In this article, we report a positive deviance case study of a high-performing UK maternity unit to examine how it achieved and sustained excellent safety outcomes. Based on 143 h of ethnographic observations in the maternity unit, 12 semi-structured interviews, and two focus groups with staff, we identified six mechanisms that appeared to be important for safety: collective competence; insistence on technical proficiency; monitoring, coordination, and distributed cognition; clearly articulated and constantly reinforced standards of practice, behaviour, and ethics; monitoring multiple sources of intelligence about the unit's state of safety; and a highly intentional approach to safety and improvement. These mechanisms were nurtured and sustained through both a specific intervention (known as the PROMPT programme) and, importantly, the unit's contextual features: intervention and context shaped each other in both direct and indirect ways. The mechanisms were also influenced by the unit's structural conditions, such as staffing levels and physical environment. This study enhances understanding of what makes a maternity unit safe, paving the way for better design of improvement approaches. It also advances the debate on quality and safety improvement by offering a theoretically and empirically grounded analysis of the interplay between interventions and context of implementation. Highlights • Maternity care continues to be a site of avoidable serious harm. • An ethnographic case study identified mechanisms linked to maternity safety. • Context and intervention are co-constitutive: neither alone is fully explanatory. • Structural influences on safety are of enduring relevance. [ABSTRACT FROM AUTHOR]

Background: Obstetric brachial plexus injuries (OBPIs) are rare but can have significant implications for those affected, their caregivers and the health system. Symptoms can range from restricted movement to complete paralysis of the arm. We investigated health-related quality of life in adults with OBPIs and parents of children with permanent OBPIs, compared these with population norms, and investigated whether certain socio-demographic or clinical factors were associated with the quality of life in these cohorts.Methods: A cross-sectional study examined 50 affected adults and 78 parents. Participants completed EQ-5D-5 L and characteristics questionnaires. EQ-5D-5 L responses were mapped onto an EQ-5D-3 L value set to generate utility scores. Mean utility scores were compared with English population norms. Univariable and multivariable linear regression models were conducted to assess for associations between participant characteristics and the utility scores.Results: The overall mean utility scores for affected adults and parents were 0.56 (SD 0.28) and 0.80 (SD 0.19) respectively. Affected adults (95% CI (- 0.38, - 0.22), p < 0.001) and parents of children with permanent OBPIs (95% CI (- 0.10, - 0.02), p = 0.007) had lower mean utility scores, and therefore quality of life, compared to English population norms. For affected adults, previous OBPI surgery (95% CI (0.01, 0.25), p = 0.040), employment in non-manual work (95% CI (0.06, 0.30), p = 0.005) and having a partner (95% CI (0.04, 0.25), p = 0.009) appeared to be positively associated with the utility score. Affected adults receiving disability benefits related to OBPIs appeared to have worse utility scores than those not receiving any disability benefits (95% CI (- 0.31, - 0.06), p = 0.005). For parents, employment was associated with better utility scores (95% CI (0.02, 0.20), p = 0.024) but the presence of one or more medical condition appeared to be associated with worse utility scores (95% CI (- 0.16, - 0.04), p = 0.001).Conclusions: Adults with OBPIs and parents of children with permanent OBPIs reported worse utility scores, and therefore quality of life, compared to the English general population. We also identified certain characteristics as possible factors to consider when dealing with utility scores in these cohorts. The utility scores in this study can be used in future economic evaluations related to OBPIs. [ABSTRACT FROM AUTHOR]

Background: Large-scale improvement programmes are a frequent response to quality and safety problems in health systems globally, but have mixed impact. The extent to which they meet criteria for programme quality, particularly in relation to transparency of reporting and evaluation, is unclear., Aim: To identify large-scale improvement programmes focused on intrapartum care implemented in English National Health Service maternity services in the period 2010-2023, and to conduct a structured quality assessment., Methods: We drew on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance to inform the design and reporting of our study. We identified relevant programmes using multiple search strategies of grey literature, research databases and other sources. Programmes that met a prespecified definition of improvement programme, that focused on intrapartum care and that had a retrievable evaluation report were subject to structured assessment using selected features of programme quality., Results: We identified 1434 records via databases and other sources. 14 major initiatives in English maternity services could not be quality assessed due to lack of a retrievable evaluation report. Quality assessment of the 15 improvement programmes meeting our criteria for assessment found highly variable quality and reporting. Programme specification was variable and mostly low quality. Only eight reported the evidence base for their interventions. Description of implementation support was poor and none reported customisation for challenged services. None reported reduction of inequalities as an explicit goal. Only seven made use of explicit patient and public involvement practices, and only six explicitly used published theories/models/frameworks to guide implementation. Programmes varied in their reporting of the planning, scope and design of evaluation, with weak designs evident., Conclusions: Poor transparency of reporting and weak or absent evaluation undermine large-scale improvement programmes by limiting learning and accountability. This review indicates important targets for improving quality in large-scale programmes., Competing Interests: Competing interests: TJD: Research and Innovation lead for PROMPT Maternity Foundation and has a part-time appointment at NHS Resolution where he leads on a Safety Action within the Maternity Incentive Scheme., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Despite increasing incidence of impacted fetal head at cesarean birth and associated injury, it is unclear which techniques are most effective for prevention and management. A high quality evidence review in accordance with international reporting standards is currently lacking. To address this gap, we aimed to identify, assess, and synthesize studies comparing techniques to prevent or manage impacted fetal head at cesarean birth prior to or at full cervical dilatation., Material and Methods: We searched MEDLINE, Emcare, Embase and Cochrane databases up to 1 January 2023 (PROSPERO: CRD420212750016). Included were randomized controlled trials (any size) and non-randomized comparative studies (n ≥ 30 in each arm) comparing techniques or adjunctive measures to prevent or manage impacted fetal head at cesarean birth. Following screening and data extraction, we assessed risk of bias for individual studies using RoB2 and ROBINS-I, and certainty of evidence using GRADE. We synthesized data using meta-analysis where appropriate, including sensitivity analyses excluding data published in potential predatory journals or at risk of retraction., Results: We identified 24 eligible studies (11 randomized and 13 non-randomized) including 3558 women, that compared vaginal disimpaction, reverse breech extraction, the Patwardhan method and/or the Fetal Pillow®. GRADE certainty of evidence was low or very low for all 96 outcomes across seven reported comparisons. Pooled analysis mostly showed no or equivocal differences in outcomes across comparisons of techniques. Although some maternal outcomes suggested differences between techniques (eg risk ratio of 3.41 [95% CI: 2.50-4.66] for uterine incision extension with vaginal disimpaction vs. reverse breech extraction), these were based on unreliable pooled estimates given very low GRADE certainty and, in some cases, additional risk of bias introduced by data published in potential predatory journals or at risk of retraction., Conclusions: The current weaknesses in the evidence base mean that no firm recommendations can be made about the superiority of any one impacted fetal head technique over another, indicating that high quality training is needed across the range of techniques. Future studies to improve the evidence base are urgently required, using a standard definition of impacted fetal head, agreed maternal and neonatal outcome sets for impacted fetal head, and internationally recommended reporting standards., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objectives: During the COVID-19 pandemic, rapid and heterogeneous changes were made to maternity care. Identification of changes that may reduce maternal health inequalities is a national priority. The aim of this project was to use data collected about care and outcomes to identify NHS Trusts in the UK where inequalities in outcomes reduced during the pandemic and explore through interviews how the changes that occurred may have led to a reduction in inequalities., Methods: A Women's Reference Group of public advisors guided the project. Analysis of Hospital Episode Statistics Admitted Patient Care data of 128 organisations in England identified "positive deviant" organisations that reduced inequalities, using maternal and perinatal composite adverse outcome indicators. Positive deviant organisations were identified for investigation, alongside comparators. Senior clinicians, heads of midwifery and representatives of women giving birth were interviewed. Reflexive thematic analysis was employed., Results: The change in the inequality gap for the maternal indicator ranged from a reduction of -0.24 to an increase of 0.30 per 1000 births between the pre-pandemic and pandemic period. For the perinatal composite indicator, the change in inequality gap ranged from -0.47 to 0.67 per 1000 births. Nine Trusts were identified as positive deviants and 10 as comparators. We conducted 20 interviews from six positive deviant and four comparator organisations. Positive deviants reported that necessary shifts in roles led to productive and novel use of expert staff; comparators reported senior staff 'stepping in' where needed and no benefits of this. They reported proactivity and quick reactions, increased team working, and rapid implementation of new ideas. Comparators found constant changes overwhelming, and no increase in team working. No specific differences in care processes were identified., Conclusions: Harnessing proactivity, flexibility, staffing resource, and increased team working proves vital in reducing health inequalities., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: High-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it., Methods: This UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers., Findings: Participants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety., Conclusions: This study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research., Competing Interests: Competing interests: TD is Vice President of the Royal College of Obstetricians and Gynaecologists. RJM has previously received BP monitors from Omron Healthcare for research purposes and is working with them on a telemonitoring system., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk., Methods: Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method., Results: CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely., Conclusions: CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces., Competing Interests: Competing interests: TD: research and innovation lead for PROMPT Maternity Foundation., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Clinical tools for use in practice-such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts-are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or 'FRESCO') offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed-one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Assisted vaginal birth rates are falling globally with rising cesarean delivery rates. Cesarean delivery is not without consequence, particularly when carried out in the second stage of labor. Cesarean delivery in the second stage is not entirely protective against pelvic floor morbidity and can lead to serious complications in a subsequent pregnancy. It should be acknowledged that the likelihood of morbidity for mother and baby associated with cesarean delivery increases with advancing labor and is greater than spontaneous vaginal birth, irrespective of the method of operative birth in the second stage of labor. In this article, we argue that assisted vaginal birth is a skilled and safe option that should always be considered and be available as an option for women who need assistance in the second stage of labor. Selecting the most appropriate mode of birth at full dilatation requires accurate clinical assessment, supported decision-making, and personalized care with consideration for the woman's preferences. Achieving vaginal birth with the primary instrument is more likely with forceps than with vacuum extraction (risk ratio, 0.58; 95% confidence interval, 0.39-0.88). Midcavity forceps are associated with a greater incidence of obstetric anal sphincter injury (odds ratio, 1.83; 95% confidence interval, 1.32-2.55) but no difference in neonatal Apgar score or umbilical artery pH. The risk for adverse outcomes is minimized when the procedure is conducted by a skilled accoucheur who selects the most appropriate instrument likely to achieve vaginal birth with the primary instrument. Anticipation of potential complications and dynamic decision-making are just as important as the technique for safe instrument use. Good communication with the woman and the birthing partner is vital and there are various recommendations on how to achieve this. There have been recent developments (such as OdonAssist) in device innovation, training, and strategies for implementation at a scale that can provide opportunities for both improved outcomes and reinvigoration of an essential skill that can save mothers' and babies' lives across the world., (Crown Copyright © 2022. Published by Elsevier Inc. All rights reserved.)

Globally, more than 1 in 5 women give birth by cesarean delivery, and at least 5% of these births are at full cervical dilatation. In these circumstances, and when labor has been prolonged in the first stage of labor, the fetal head can become low and wedged deep in the woman's pelvis, making it difficult to deliver the baby. This emergency is known as impacted fetal head. These are technically challenging births associated with serious risks to both the woman and the baby. The difficulty in disimpacting the fetal head increases maternal risks of hemorrhage and injury to adjacent organs and may have long-term consequences for future pregnancies. In addition, there can be associated neonatal consequences, such as skull fractures, brain hemorrhage, hypoxic brain injury, and, rarely, perinatal death. Globally, maternity staff are increasingly encountering this emergency, with studies in the United Kingdom suggesting that impacted fetal head may complicate as many as 1 in 10 emergency cesarean deliveries. Moreover, there has been a sharp increase in reports of perinatal brain injuries associated with impaction of the fetal head at cesarean delivery. When an impacted fetal head occurs, the maternity team can employ a range of approaches to help deliver the fetal head, including an assistant (another obstetrician or midwife) pushing the head up from the vagina, delivering the baby feet first (reverse breech extraction), administering tocolysis to relax the uterus, and using a balloon cephalic elevation device (Fetal Pillow) to elevate the baby's head. However, there is currently no consensus on how best to manage these births, resulting in a lack of confidence among maternity staff, variable practice, and potentially avoidable harm in some circumstances. This article examined the evidence for the prevention and management of this critical obstetrical emergency and outlined recommendations for best practices and training., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Decreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability., Objective: This study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial., Study Design: An open-label nonrandomized study of 104 participants having a clinically indicated assisted vaginal birth using the OdonAssist was undertaken at Southmead Hospital, Bristol, United Kingdom. Data were also collected from participants who consented to participate in the study but for whom trained OdonAssist operators were not available, providing a nested cohort. The primary clinical outcome was the proportion of births successfully expedited with the OdonAssist. Secondary outcomes included clinical, patient-reported, operator-reported, device and health care utilization. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Given that the number of successful OdonAssist births was ≥61 out of 104, the hypothesis of a poor rate of 50% was rejected in favor of a good rate of ≥65%., Results: Between August 2019 and June 2021, 941 (64%) of the 1471 approached, eligible participants consented to participate. Of these, 104 received the OdonAssist intervention. Birth was assisted in all cephalic vertex fetal positions, at all stations ≥1 cm below the ischial spines (with or without regional analgesia). The OdonAssist was effective in 69 of the 104 (66%) cases, consistent with the hypothesis of a good efficacy rate. There were no serious device-related maternal or neonatal adverse reactions, and there were no serious adverse device effects. Only 4% of neonatal soft tissue bruising in the successful OdonAssist group was considered device-related, as opposed to 20% and 23% in the unsuccessful OdonAssist group and the nested cohort, respectively. Participants reported high birth perception scores. All practitioners found the device use to be straightforward., Conclusion: Recruitment to an interventional study of a new device for assisted vaginal birth is feasible; 64% of eligible participants were willing to participate. The success rate of the OdonAssist was comparable to that of the Kiwi OmniCup when introduced in the same unit in 2002, meeting the threshold for a randomized controlled trial to compare the OdonAssist with current standard practice. There were no disadvantages of study participation in terms of maternal and neonatal outcomes. There were potential advantages of using the OdonAssist, particularly reduced neonatal soft tissue injury. The same application technique is used for all fetal positions, with all operators deeming the device straightforward to use. This study provides important data to inform future study design., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The first feasibility study of the OdonAssist inflatable device for use in clinically indicated assisted vaginal birth reported a success rate of 48% with no significant safety concerns. Additional studies exploring the device performance in other clinical settings are warranted before definitive conclusions can be drawn about its safety and efficacy in current practice., Objective: This study aimed to investigate the safety and efficacy of the OdonAssist before conducting a randomized controlled trial., Study Design: This was an open-label, nonrandomized study of 104 women with a clinically indicated assisted vaginal birth using the OdonAssist at the Besancon University Hospital, France. Data, including those of a nested cohort group of women who had an assisted vaginal birth using vacuum or spatulas because a trained OdonAssist device operator was not available at the time of delivery, were collected. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist. Neonatal outcome data were reviewed at days 1 and 28, and maternal outcomes were investigated up to day 90., Results: Between December 2019 and May 2021, 2191 pregnant women were approached, and 83% (1636/1973) of them consented to participate in the study. Among them, 10.7% (176/1636) required an assisted vaginal birth owing to a vertex presentation at +1 and below. The OdonAssist was used in 59% of births (104/176), and 41.1% (72/176) of the participants were included in the nested cohort group. The rate of successful assisted vaginal births using the OdonAssist was 88.5% (92/104). No emergency cesarean deliveries were performed in the OdonAssist group. There were no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8% (4/104). The maternal perception ratings of the birth experience with the OdonAssist (collected on days 1, 7, and 28 using a 15-point scale) were high. In addition, the operators reported a positive perception of the device, with ease of use across the different steps of the procedure. One single technique was used for all vertex fetal head positions., Conclusion: The OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births. The high acceptance rate (83%) among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirm the feasibility of a future randomized controlled trial., (Crown Copyright © 2023. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate the hypothesis that risk factors in addition to an abnormal fetal heart rate pattern (aFHRp) are independently associated with adverse neonatal outcomes of labour., Design: Observational prospective cohort study., Setting: 17 UK maternity units., Sample: 585 291 pregnancies between 1988 and 2000 inclusive., Methods: Adjusted odds ratios (OR) with 95% confidence intervals (95% CI) were estimated from multivariable logistic regression., Main Outcome Measures: Adverse neonatal outcome at term (5-minute Apgar score <7, and a composite measure comprising 5-minute Apgar score <7, resuscitation by intubation and/or perinatal death)., Results: Analysis was based on 302 137 vaginal births at 37-42 weeks inclusive. We found a higher odds of Apgar score at 5 minutes <7 with suspected fetal growth restriction (OR 1.34, 95% CI 1.16-1.53), induction of labour (OR 1.41, 95% CI 1.25-1.58), nulliparity (OR 1.48, 95% CI 1.34-1.63), booking body mass index ≥30 (OR 1.18, 95% CI 1.02-1.37), maternal age <25 (OR 1.23, 95% CI 1.10-1.39), black ethnicity (OR 1.21, 95% CI 1.03-1.43), early-term birth at 37-38 weeks (OR 1.13, 95% CI 1.02-1.25), late-term birth at 41-42 weeks (OR 1.14, 95% CI 1.01-1.28), use of oxytocin (OR 1.27, 95% CI 1.14-1.41), maternal pyrexia (OR 1.87, 95% CI 1.46-2.40), aFHRp and presence of meconium (aFHRp without meconium: OR 2.40, 95% CI 2.15-2.69; meconium without aFHRp: OR 2.20, 195% CI.94-2.49; both aFHRp and meconium: OR 4.26, 95% CI 3.74-4.87). The results were similar when the composite adverse outcome was considered., Conclusions: A range of risk factors, including suspicion of fetal growth restriction, maternal pyrexia and presence of meconium, are implicated in poor birth outcomes in addition to aFHRp. Interpretation of the fetal heart rate pattern alone is insufficient as a basis for decisions about escalation and intervention., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Over one-quarter of women in the UK have a caesarean birth (CB). More than one in 20 of these births occurs near the end of labour, when the cervix is fully dilated (second stage). In these circumstances, and when labour has been prolonged, the baby's head can become lodged deep in the maternal pelvis making it challenging to deliver the baby. During the caesarean birth, difficulty in delivery of the baby's head may result - this emergency is known as impacted fetal head (IFH). These are technically challenging births that pose significant risks to both the woman and baby. Complications for the woman include tears in the womb, serious bleeding and longer hospital stay. Babies are at increased risk of injury including damage to the head and face, lack of oxygen to the brain, nerve damage, and in rare cases, the baby may die from these complications. Maternity staff are increasingly encountering IFH at CB, and reports of associated injuries have risen dramatically in recent years. The latest UK studies suggest that IFH may complicate as many as one in 10 unplanned CBs (1.5% of all births) and that two in 100 babies affected by IFH die or are seriously injured. Moreover, there has been a sharp increase in reports of babies having brain injuries when their birth was complicated by IFH. When an IFH occurs, the maternity team can use different approaches to help deliver the baby's head at CB. These include: an assistant (another obstetrician or midwife) pushing the head up from the vagina; delivering the baby feet first; using a specially designed inflatable balloon device to elevate the baby's head and/or giving the mother a medicine to relax the womb. However, there is currently no consensus for how best to manage these births. This has resulted in a lack of confidence among maternity staff, variable practice and potentially avoidable harm in some circumstances. This paper reviews the current evidence regarding the prediction, prevention and management of IFH at CB, integrating findings from a systematic review commissioned from the National Guideline Alliance., (© 2023 Royal College of Obstetricians and Gynaecologists.)

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth., ((c) 2023 The authors; licensee World Health Organization.)

Objective: We aimed to explore the experiences and perspectives of pregnant women, antenatal healthcare professionals, and system leaders to understand the impact of the implementation of remote provision of antenatal care during the COVID-19 pandemic and beyond., Methods: We conducted a qualitative study involving semi-structured interviews with 93 participants, including 45 individuals who had been pregnant during the study period, 34 health care professionals, and 14 managers and system-level stakeholders. Analysis was based on the constant comparative method and used the theoretical framework of candidacy., Results: We found that remote antenatal care had far-reaching effects on access when understood through the lens of candidacy. It altered women's own identification of themselves and their babies as eligible for antenatal care. Navigating services became more challenging, often requiring considerable digital literacy and sociocultural capital. Services became less permeable, meaning that they were more difficult to use and demanding of the personal and social resources of users. Remote consultations were seen as more transactional in character and were limited by lack of face-to-face contact and safe spaces, making it more difficult for women to make their needs - both clinical and social - known, and for professionals to assess them. Operational and institutional challenges, including problems in sharing of antenatal records, were consequential. There were suggestions that a shift to remote provision of antenatal care might increase risks of inequities in access to care in relation to every feature of candidacy we characterised., Conclusion: It is important to recognise the implications for access to antenatal care of a shift to remote delivery. It is not a simple swap: it restructures many aspects of candidacy for care in ways that pose risks of amplifying existing intersectional inequalities that lead to poorer outcomes. Addressing these challenges through policy and practice action is needed to tackle these risks.

Introduction: This study assessed views, understanding and current practices of maternity professionals in relation to impacted fetal head at cesarean birth, with the aim of informing a standardized definition, clinical management approaches and training., Material and Methods: We conducted a survey consultation including the range of maternity professionals who attend emergency cesarean births in the UK. Thiscovery, an online research and development platform, was used to ask closed-ended and free-text questions. Simple descriptive analysis was undertaken for closed-ended responses, and content analysis for categorization and counting of free-text responses. Main outcome measures included the count and percentage of participants selecting predefined options on clinical definition, multi-professional team approach, communication, clinical management and training., Results: In total, 419 professionals took part, including 144 midwives, 216 obstetricians and 59 other clinicians (eg anesthetists). We found high levels of agreement on the components of an impacted fetal head definition (79% of obstetricians) and the need for use of a multi-professional approach to management (95% of all participants). Over 70% of obstetricians deemed nine techniques acceptable for management of impacted fetal head, but some obstetricians also considered potentially unsafe practices appropriate. Access to professional training in management of impacted fetal head was highly variable, with over 80% of midwives reporting no training in vaginal disimpaction., Conclusions: These findings demonstrate agreement on the components of a standardized definition for impacted fetal head, and a need and appetite for multi-professional training. These findings can inform a program of work to improve care, including use of structured management algorithms and simulation-based multi-professional training., (© 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK., Objectives: To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams., Methods: The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups., Results: Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%-92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%-100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners., Conclusions: The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Impacted fetal head (IFH) is a challenging complication of cesarean section (CS) associated with significant morbidity. Training opportunities for IFH have been reported as inconsistent and inadequate. This study assessed the validity of a novel birth simulator for IFH at cesarean section., Material and Methods: Obstetricians and midwives collaborated with model-making company, Limbs & Things (UK), to modify the original PROMPT Flex® simulator and develop a new "Enhanced CS Module" for IFH at cesarean section. Changes included addition of a retractable uterus and restricted pelvic inlet, and the fetal mannequin was modified to allow accurate limb articulation and flexion at the waist. Obstetricians and midwives from three maternity units in Southwest England were individually recorded, each undertaking three simulated scenarios of IFH at cesarean section. Obstetricians were asked to deliver the fetal head and midwives, to perform a vaginal push-up. Participants completed a questionnaire on realism (face validity) and usefulness for training (content validity) with five-point Likert scale responses. Construct validity was assessed by testing an a priori hypothesis that "experts" (consultant obstetricians with >7 years' experience) would be more likely to achieve delivery than "novices" (registrars with <7 years' experience). Performance variables were compared between groups using Chi-square and Mann-Whitney U-tests., Results: In all, 105 simulated scenarios were undertaken by 35 obstetricians and midwives. A range of techniques were employed to deliver the IFH including change of hand, vaginal disimpaction and reverse breech extraction. Overall, 86% (30/35) described the model as fairly (4)/very realistic (5) (median = 4, interquartile range [IQR] = 4-5). The model was considered fairly (4)/very useful (5) for training by 97% (34/35; median = 5; IQR = 5-5). Experts delivered the fetal head in all simulations (36/36) and novices delivered the head in 76.9% (30/39) (p = 0.002). Experts delivered the fetal head 58% quicker than novices (median = 66.8 s, IQR = 53-86 vs median = 104 s, IQR = 67.7-137)., Conclusions: This novel birth trainer realistically simulates IFH at cesarean section and allows rehearsal of all disimpaction techniques. It was reported to be very useful for training and distinguishes between novice and expert obstetricians. Techniques for IFH are difficult to learn experientially. Simulation is likely to provide an effective and safe form of training., (© 2022 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: Considering the public health importance of stillbirth, this study quantified the trends in stillbirths over eight decades in England and Wales., Methods: This longitudinal study utilized the publicly available aggregated data from the Office for National Statistics that captured maternity information for babies delivered in England and Wales from 1940 to 2019. We computed the trends in stillbirth with the associated incidence risk difference, incidence risk ratio, and extra lives saved per decade., Results: From 1940-2019, 56 906 273 births were reported. The stillbirth rate declined (85%) drastically up to the early 1980s. In the initial five decades, the estimated number of deaths per decade further decreased by 67 765 (9.49/1000 births) in 1940-1949, 2569 (0.08/1000 births) in 1950-1959, 9121 (3.50/1000 births) in 1960-1969, 15 262 (2.31/1000 births) in 1970-1979, and 10 284 (1.57/1000 births) in 1980-1989. However, the stillbirth rate increased by an additional 3850 (0.58/1000 births) stillbirths in 1990-1999 and 693 (0.11/1000 births) stillbirths in 2000-2009. The stillbirth rate declined again during 2010-2019, with 3714 fewer stillbirths (0.54/1000 births). The incidence of maternal age <20 years reduced over time, but pregnancy among older women (>35 years) increased., Conclusions: The stillbirth rate declined drastically, but the rate of decline slowed in the last three decades. Though teenage pregnancy (<20 years) had reduced, the prevalence of women with a higher risk of stillbirth may have risen due to an increase in advanced maternal age. Improved, more personalised care is required to reduce the stillbirth rate further., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and declare no relevant interests., (Copyright © 2022 by the Journal of Global Health. All rights reserved.)

Competing Interests: EM is President of the Royal College of Obstetricians and Gynaecologists (RCOG). PO is Vice President of the RCOG and co-chair of the RCOG Vaccine Committee. TD is Vice President of the RCOG. We declare no competing interests.

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., (© 2022. The Author(s).)

Objective: When 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., Design: We 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., Setting: Tertiary referral National Health Service maternity unit in the Southwest of England., Participants: Women requiring a clinically indicated assisted vaginal birth., Intervention: The Odon Device, an innovative device for assisted vaginal birth., Primary and Secondary Outcome Measures: Determining the optimal device technique, device design and defining clinical parameters for use., Results: Thirty-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., Conclusions: Case 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 Number: ISRCTN10203171., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

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., (© 2022. The Author(s).)

Objective: To 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., Design: Qualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study., Setting: A tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019., Participants: Eight 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., Intervention: The Odon Device, an innovative device for assisted vaginal birth., Results: Thirty-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., Conclusions: Interviews 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 Number: ISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171., Competing Interests: Competing interests: EL is a member of University of Bristol (UoB) and part of his salary is paid by PROMPT Maternity Foundation (PMF); PMF has received funding from a Saving Lives at Birth award via a subcontract from Becton, Dickinson and Company (BD) to conduct preclinical simulation studies of the Odon Device, these funds have been used towards the salary of TJD and JFC when undertaking the simulations studies. All other authors report no competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Some studies have suggested that women with SARS-CoV-2 infection during pregnancy are at increased risk of adverse pregnancy and neonatal outcomes, but these associations are still not clear., Objective: This study aimed to determine the association between SARS-CoV-2 infection at the time of birth and maternal and perinatal outcomes., Study Design: This is a population-based cohort study in England. The inclusion criteria were women with a recorded singleton birth between May 29, 2020, and January 31, 2021, in a national database of hospital admissions. Maternal and perinatal outcomes were compared between pregnant women with a laboratory-confirmed SARS-CoV-2 infection recorded in the birth episode and those without. Study outcomes were fetal death at or beyond 24 weeks' gestation (stillbirth), preterm birth (<37 weeks' gestation), small for gestational age infant (small for gestational age; birthweight at the .05) in the rate of other maternal outcomes. The risk of neonatal adverse outcome (adjusted odds ratio, 1.45; 95% confidence interval, 1.27-1.66; P<.001), need for specialist neonatal care (adjusted odds ratio, 1.24; 95% confidence interval, 1.02-1.51; P=.03), and prolonged neonatal admission after birth (adjusted odds ratio, 1.61; 95% confidence interval, 1.49-1.75; P<.001) were all significantly higher for infants with mothers with laboratory-confirmed SARS-CoV-2 infection. When the analysis was restricted to pregnancies delivered at term (≥37 weeks), there were no significant differences in neonatal adverse outcome (P=.78), need for specialist neonatal care after birth (P=.22), or neonatal readmission within 4 weeks of birth (P=.05). Neonates born at term to mothers with laboratory-confirmed SARS-CoV-2 infection were more likely to have prolonged admission after birth (21.1% compared with 14.6%; adjusted odds ratio, 1.61; 95% confidence interval, 1.49-1.75; P<.001)., Conclusion: SARS-CoV-2 infection at the time of birth is associated with higher rates of fetal death, preterm birth, preeclampsia, and emergency cesarean delivery. There were no additional adverse neonatal outcomes, other than those related to preterm delivery. Pregnant women should be counseled regarding risks of SARS-CoV-2 infection and should be considered a priority for vaccination., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: In healthcare, there is increasing recognition of the importance of developing and testing strategies to scale effective interventions. The NHS long-term plan (2019) acknowledges that often a gold standard approach to a problem already exists somewhere within the NHS, however, it has not been replicated widely across the system., Methods: We describe the approach and process measures for national scaling of PROMPT (Practical Obstetric Multi-Professional Training) across 12 obstetric-led maternity units in Wales. PROMPT is an evidence-based training package for local maternity staff, previously associated with improvements in maternal and neonatal outcomes, reduction in litigation related to preventable harm and improved safety culture. PROMPT has previously been disseminated internationally using a train-the-trainer model. However, this has been associated with variations in uptake, fidelity and impact. In Wales, the project was supported by Welsh Government, and a structured scaling plan was developed, encompassing ongoing implementation support from a multi-professional team., Results: PROMPT was successfully implemented in all obstetric led units in Wales, with 326 local PROMPT facilitators trained, and 82.5%-100% of maternity staff attended a local PROMPT course in the first 15 months of the project (January 2019-March 2020). All training courses included evidence-based authentic elements, and 93% of courses in the first year (100/107) were supported by a national implementation team, providing coaching, implementation support and quality assurance., Conclusions: Authentically scaling up complex interventions is a significant challenge. To replicate the improved outcomes demonstrated by PROMPT, intervention reach and fidelity must first be demonstrated.In this national scaling project, our scaling methodology led to the successful implementation of PROMPT across all health boards in Wales. Additionally, we demonstrated reduced variation in adoption, reach, timescale and intervention fidelity between maternity units with varying readiness for change, which had been difficult in two previous large-scale PROMPT implementation projects., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The COVID-19 pandemic has had a profound impact on healthcare systems globally, with a worrying increase in adverse maternal and foetal outcomes. We aimed to assess the changes in maternity healthcare provision and healthcare-seeking by pregnant women during the COVID-19 pandemic., Methods: We performed a systematic review and meta-analysis of studies of the effects of the pandemic on provision of, access to and attendance at maternity services (CRD42020211753). We searched MEDLINE and Embase in accordance with PRISMA guidelines from January 1st, 2020 to April 17th 2021 for controlled observational studies and research letters reporting primary data comparing maternity healthcare-seeking and healthcare delivery during compared to before the COVID-19 pandemic. Case reports and series, systematic literature reviews, and pre-print studies were excluded. Meta-analysis was performed on comparable outcomes that were reported in two or more studies. Data were combined using random-effects meta-analysis, using risk ratios (RR) or incidence rate ratios (IRR) with 95% confidence intervals (CI)., Findings: Of 4743 citations identified, 56 were included in the systematic review, and 21 in the meta-analysis. We identified a significant decrease in the number of antenatal clinic visits (IRR 0614, 95% CI 0486-0776, P <00001, I 2 =54.6%) and unscheduled care visits (IRR 0741, 95% CI 0602-0911, P  = 00046, I 2 =00%) per week, and an increase in virtual or remote antenatal care (IRR 4656 95% CI 7762-2794, P <00001, I 2 =90.6%) and hospitalisation of unscheduled attendees (RR 1214, 95% CI 1118-1319, P <00001, I 2 =00%). There was a decrease in the use of GA for category 1 Caesarean sections (CS) (RR 0529, 95% CI 0407-0690, P <00001, I 2 =00%). There was no significant change in intrapartum epidural use ( P  = 00896) or the use of GA for elective CS ( P  = 079)., Interpretation: Reduced maternity healthcare-seeking and healthcare provision during the COVID-19 pandemic has been global, and must be considered as potentially contributing to worsening of pregnancy outcomes observed during the pandemic., Competing Interests: Dr Morris reports grants and other from Gedeon Richter, grants and other from Chugai Pharma, personal fees from Pfizer, personal fees from Gedeon Richter, other from Kebomed, from null, outside the submitted work; and President and Trustee, RCOG Trustee, British Menopause Society Chair of Trustees, Group B Strep Support., (© 2021 The Author(s).)

Objective: To investigate risk factors, management and outcomes of impacted fetal head (IFH) at caesarean section (CS)., Study Design: This is a retrospective cohort study of all women with singleton, cephalic pregnancies who had an emergency CS during one-year (2016) at North Bristol NHS Trust, UK (n = 838). The incidence of caesarean section at full dilatation (CSFD) and IFH were calculated using the annual birth rate. To identify risk factors for IFH, maternal, perinatal and intrapartum characteristics were compared according to the presence or absence of IFH, and separately for first- and second-stage CS. Techniques employed to disimpact the fetal head were described. Univariable and multivariable comparisons of maternal and perinatal outcomes were made between cases with and without an IFH. Characteristics and outcomes were compared using modified Poisson regression., Results: CSFD accounted for 2.1 % of all births. IFH complicated 1.5 % of all births (11.3 % of emergency CS), with 55.8 % occurring prior to full cervical dilatation. Increased rates of IFH at CS were associated with: oxytocin augmentation (RR = 2.47 [1.61-3.80]), full cervical dilatation (RR = 4.24 [2.96-6.07], mid/low station (RR = 4.14 [2.72-6.32]), moulding (RR = 4.39 [2.55-7.54]) and caput (RR = 6.60 [3.09-14.10]). Junior operators documented IFH more than consultants (RR = 9.61 [1.35-68.2]). The strategies recorded for managing IFH included: tocolysis, reverse breech extraction and vaginal push up (33.7 %, 14.7 % and 11.6 % cases respectively) with two or more techniques used in 21.1 % cases. IFH at CS was independently associated with an increased risk of uterine extensions (RR = 3.09 [1.96-4.87]) and a composite adverse perinatal outcome (RR = 1.66 [1.21-2.28])., Conclusions: IFH is a common and heterogeneous complication associated with increased complications for both mother and baby, independent of those of CSFD. Obstetricians must remain vigilant to the possibility of IFH at all emergency CS, particularly those at full cervical dilatation or with evidence of obstructed labour. There is an urgent need for a standardised management algorithm and training in evidence-based disimpaction techniques., Competing Interests: Declaration of Competing Interest The authors report no declarations of interest., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: The COVID-19 pandemic has had a profound impact on health-care systems and potentially on pregnancy outcomes, but no systematic synthesis of evidence of this effect has been undertaken. We aimed to assess the collective evidence on the effects on maternal, fetal, and neonatal outcomes of the pandemic., Methods: We did a systematic review and meta-analysis of studies on the effects of the pandemic on maternal, fetal, and neonatal outcomes. We searched MEDLINE and Embase in accordance with PRISMA guidelines, from Jan 1, 2020, to Jan 8, 2021, for case-control studies, cohort studies, and brief reports comparing maternal and perinatal mortality, maternal morbidity, pregnancy complications, and intrapartum and neonatal outcomes before and during the pandemic. We also planned to record any additional maternal and offspring outcomes identified. Studies of solely SARS-CoV-2-infected pregnant individuals, as well as case reports, studies without comparison groups, narrative or systematic literature reviews, preprints, and studies reporting on overlapping populations were excluded. Quantitative meta-analysis was done for an outcome when more than one study presented relevant data. Random-effects estimate of the pooled odds ratio (OR) of each outcome were generated with use of the Mantel-Haenszel method. This review was registered with PROSPERO (CRD42020211753)., Findings: The search identified 3592 citations, of which 40 studies were included. We identified significant increases in stillbirth (pooled OR 1·28 [95% CI 1·07-1·54]; I 2 =63%; 12 studies, 168 295 pregnancies during and 198 993 before the pandemic) and maternal death (1·37 [1·22-1·53; I 2 =0%, two studies [both from low-income and middle-income countries], 1 237 018 and 2 224 859 pregnancies) during versus before the pandemic. Preterm births before 37 weeks' gestation were not significantly changed overall (0·94 [0·87-1·02]; I 2 =75%; 15 studies, 170 640 and 656 423 pregnancies) but were decreased in high-income countries (0·91 [0·84-0·99]; I 2 =63%; 12 studies, 159 987 and 635 118 pregnancies), where spontaneous preterm birth was also decreased (0·81 [0·67-0·97]; two studies, 4204 and 6818 pregnancies). Mean Edinburgh Postnatal Depression Scale scores were higher, indicating poorer mental health, during versus before the pandemic (pooled mean difference 0·42 [95% CI 0·02-0·81; three studies, 2330 and 6517 pregnancies). Surgically managed ectopic pregnancies were increased during the pandemic (OR 5·81 [2·16-15·6]; I 2 =26%; three studies, 37 and 272 pregnancies). No overall significant effects were identified for other outcomes included in the quantitative analysis: maternal gestational diabetes; hypertensive disorders of pregnancy; preterm birth before 34 weeks', 32 weeks', or 28 weeks' gestation; iatrogenic preterm birth; labour induction; modes of delivery (spontaneous vaginal delivery, caesarean section, or instrumental delivery); post-partum haemorrhage; neonatal death; low birthweight (<2500 g); neonatal intensive care unit admission; or Apgar score less than 7 at 5 min., Interpretation: Global maternal and fetal outcomes have worsened during the COVID-19 pandemic, with an increase in maternal deaths, stillbirth, ruptured ectopic pregnancies, and maternal depression. Some outcomes show considerable disparity between high-resource and low-resource settings. There is an urgent need to prioritise safe, accessible, and equitable maternity care within the strategic response to this pandemic and in future health crises., Funding: None., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications., Objective: This study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study., Study Design: This is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90., Results: Between October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention-the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator)., Conclusion: Recruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)