Management of impacted fetal head at cesarean delivery.

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.

Assisted vaginal birth in 21st century: current practice and new innovations.

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.

The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom).

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.

Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study.

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.

Quality and reporting of large-scale improvement programmes: a review of maternity initiatives in the English NHS, 2010-2023.

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.

Why is safety in intrapartum electronic fetal monitoring so hard? A qualitative study combining human factors/ergonomics and social science analysis.

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.

How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study.

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.

A research agenda to improve incidence and outcomes of assisted vaginal birth.

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.

L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.

El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.

Training for managing impacted fetal head at caesarean birth: multimethod evaluation of a pilot.

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.

Definition, management, and training in impacted fetal head at cesarean birth: a national survey of maternity professionals.

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.

Management of Impacted Fetal Head at Caesarean Birth: Scientific Impact Paper No. 73.

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.

Risk factors for a serious adverse outcome in neonates: a retrospective cohort study of vaginal births.

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.

A qualitative study of the dynamics of access to remote antenatal care through the lens of candidacy.

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.

Validation of a novel birth simulator for impacted fetal head at cesarean section: An observational simulation study.

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.

Temporal trends in stillbirth over eight decades in England and Wales: A longitudinal analysis of over 56 million births and lives saved by improvements in maternity care.

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.

The Tommy's Clinical Decision Tool, a device for reducing the clinical impact of placental dysfunction and preterm birth: protocol for a mixed-methods early implementation evaluation study.

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 31st January 2022.

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England.

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.

Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy.

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, I2 = 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, I2 = 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.