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.

Women's and midwives' views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study.

BACKGROUND: Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss and answer questions whilst maintaining equipoise. However, little is known about these interactions. An integrated qualitative study (IQS) was used to investigate information provision for women invited to participate in the Assist II feasibility study investigating the OdonAssist™-a novel device for use in assisted vaginal birth with an aim to generate a framework of good practice for information provision. METHODS: Transcripts of in-depth interviews with women participants (n = 25), with recruiting midwives (n = 6) and recruitment discussions between midwives and women (n = 21), accepting or declining participation, were coded and interpreted using thematic analysis and content analysis to investigate what was helpful to women and what could be improved. RESULTS: Recruiting women to intrapartum research is complicated by factors that impact on women's understanding and decision-making. Three key themes were derived from the data: (i) a woman-centred recruitment process, (ii) optimising the recruitment discussion and (iii) making a decision for two. CONCLUSION: Despite evidence from the literature that women would like information provision and the research discussion to take place in the antenatal period, intrapartum studies still vary in the recruitment processes they offer women. Particularly concerning is that some women are given information for the first time whilst in labour, when they are known to feel particularly vulnerable, and contextual factors may influence decision-making; therefore, we propose a framework for good practice for information provision for research involving interventions initiated in the intrapartum period as a woman centred, and acceptable model of recruitment, which addresses the concerns of women and midwives and facilitates fair inclusion into intrapartum trials. TRIAL REGISTRATION: ISRCTN. This qualitative research was undertaken as part of the ASSIST II Trial (trial registration number: ISRCTN38829082. Prospectively registered on 26/06/2019).

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.

Assisted vaginal birth with the Odon DeviceTM.

The Odon DeviceTM is an innovative investigational device for assisted vaginal birth (AVB) and has not yet been granted regulatory approval for sale in any country. It is the first innovation in AVB since the introduction of the vacuum extractor in the 1950's and the device is designed for use by different level of trained health care providers. Efficacy studies are presently in progress in two centers: The ASSIST II Study, Bristol, England, and The BESANCON ASSIST Study, Besançon, France. The device consists of an applicator, sleeve and cuff. This original paper illustrates the operating process in real conditions.

Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England.

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.

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.

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.

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy-The ASSIST II study.

BACKGROUND: The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. METHODS: The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A'Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. DISCUSSION: The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. TRIAL REGISTRATION: ISRCTN registration: 38829082 (prospectively registered July 26, 2019).

Outcomes of the novel Odon Device in indicated operative vaginal birth.

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.

Simulation for intrapartum care: from training to novel device innovation.

Improving maternal and perinatal care is a global priority. Simulation training and novel applications of simulation for intrapartum care may help to reduce preventable deaths worldwide. Evaluation studies have published details of the effectiveness of simulation training for obstetric emergencies, exploring clinical and non-clinical factors as well as the impact on patient outcomes (both maternal and neonatal). This review summarized the many uses of simulation in obstetric emergencies from training to assessment. It also described the adaption of training in low-resource settings and the evidence behind the equipment recommended to support simulation training. The review also discussed novel applications for simulation such as its use in the development of a new device for assisted vaginal birth and its potential role in Cesarean section training. This study analyzed the financial implications of simulation training and how this may impact the delivery of such training packages, considering that simulation should be developed and utilized as a key tool in the development of safe intrapartum care in both emergency and non-emergency settings, in innovation and product development.

Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

INTRODUCTION: Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study. METHODS AND ANALYSIS: Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed. ETHICS AND DISSEMINATION: Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study.

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

Myths and realities of training in obstetric emergencies.

Training for intrapartum emergencies is a promising strategy to reduce preventable harm during birth; however, not all training is clinically effective. Many myths have developed around such training. These principally derive from misinformed beliefs that all training must be effective, cheap, independent of context and sustainable. The current evidence base for effective training supports local, unit-based and multi-professional training, with appropriate mannequins, and practice-based tools to support the best care. Training programmes based on these principles are associated with improved clinical outcomes, but we need to understand how and why that is, and also why some training is associated with no improvements, or even deterioration in outcomes. Effective training is not cheap, but it can be cost-effective. Insurers have the fiscal power to incentivise training, but they should demand the evidence of clinical effect; aspiration and proxies alone should no longer be sufficient for funding, in any resource setting.

Onsite training of doctors, midwives and nurses in obstetric emergencies, Zimbabwe.

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

The incarcerated gravid uterus: complications and lessons learned.

BACKGROUND: Incarcerated uterus is a rare but serious complication. CASES: Two women presented with second trimester urinary retention. Neither received a pelvic examination at presentation, which led to a delay in diagnosing the incarcerated uterus. Patient 1 had development of acute renal failure, hypertension, and edema. After uterine reduction there was rapid normalization of renal function, hypertension, and edema, but spontaneous rupture of membranes and intrauterine death occurred 12 hours later. Patient 2 had reduction under anesthetic and subsequently underwent cesarean delivery at term. However, at 7 months postpartum, the patient continued to have high postvoid residual volumes. CONCLUSION: Women presenting with urinary retention in the second trimester should have a pelvic examination performed to exclude uterine incarceration. Earlier recognition and appropriate treatment may have altered the outcome for the two patients presented.

Retention of factual knowledge after practical training for intrapartum emergencies.

OBJECTIVE: To determine knowledge retention 1 year after training for intrapartum emergencies. METHODS: Training was undertaken in 6 hospitals and the Bristol Medical Simulation Centre, UK, between November 2004 and March 2005. Participants (22 junior and 23 senior doctors, 47 junior and 48 senior midwives) were randomly recruited from participating hospitals and underwent practical training at their local hospital or simulation center with or without additional teamwork training. The primary outcome was change in factual knowledge over time, as assessed by a 185-question multiple-choice questionnaire before and after training. RESULTS: Mean scores at 6 (97.6 ± 23.0; n = 107) and 12 (98.2 ± 21.6; n = 98) months remained higher than those before training (79.6 ± 21.9, n = 140; both P < 0.001), but were slightly lower than those immediately after training (101.0 ± 21.3, n = 133; P < 0.001 and P = 0.007, respectively). The type of training had no effect on retention of knowledge. CONCLUSION: Training was associated with sustained retention of factual knowledge of obstetric emergencies care for at least 1 year. The decay in knowledge was small compared with the original gain in knowledge. Neither training location nor inclusion of teamwork training affected knowledge retention. Annual training seemed to be satisfactory for all staff groups.

Team communication with patient actors: findings from a multisite simulation study.

INTRODUCTION: Patient satisfaction is an important healthcare outcome and communication with clinical staff is an important determinant. Simulation could identify problems and inform corrective action to improve patient experience. METHODS: One hundred eight randomly selected maternity professionals in 18 teams were videoed managing a patient-actor with a simulated emergency. The trained patient-actor assessed the quality of staff-patient interaction. Clinicians scored teams for their teamwork skills and behaviors. RESULTS: There was significant variation in staff-patient interaction, with some teams not having exchanged a single word and others striving to interact with the patient-actor in the heat of the emergency. There was significant correlation between patient-actor perceptions of communication, respect, and safety and individual and team behaviors: number, duration, and content of communication episodes, as well as generic teamwork skills and teamwork behaviors. The patient-actor perception of safety was better when the content of the communication episodes with them included certain items of information, but most teams failed to communicate these to the patient-actor. CONCLUSION: Some aspects of staff-patient interaction and teamwork during management of a simulated emergency varied significantly and were often inadequate in this study, indicating a need for better training of individuals and teams.

The use of simulation to teach clinical skills in obstetrics.

Obstetrical practice demands sensitivity, clinical skill, and acumen. Obstetrical emergencies are rare occurrences and are most appropriately dealt with by experienced staff. Simulation provides an opportunity to gain this experience without patient risk and furthermore builds confidence and satisfaction amongst learners. There is an abundance of evidence to show the effectiveness of simulation training. Simulation has been demonstrated to reduce errors, increase knowledge, skills, communication and team working, and improve perinatal outcomes. Further research to measure the effect of training to identify what works, where and at what cost is needed. We explore the evidence for the use of simulation-based training across a broad range of obstetrical emergencies, promote collaboration amongst disciplines and discuss the formal introduction of simulation training into a curriculum. Reducing preventable harm in obstetrics is a priority for families and society at large and this article endeavors to highlight the role that simulation has to play.

The management of a simulated emergency: better teamwork, better performance.

OBJECTIVES: To determine whether team performance in a simulated emergency is related to generic teamwork skills and behaviours. METHODS: Design - Cross-sectional analysis of data from the Simulation and Fire-drill Evaluation (SaFE) randomised controlled trial. Setting - Six secondary and tertiary Maternity Units in Southwest England. Participants - 140 healthcare professionals, in 24 teams. Assessment - Blinded analysis of recorded simulations. Main outcome measures - Correlation of team performance (efficiency conducting key clinical actions, including the administration of an essential drug, magnesium), and generic teamwork scores (using a validated tool that assesses skills and behaviours, by Weller et al.). RESULTS: There was significant positive correlation between clinical efficiency and teamwork scores across all three dimensions; skills (Kendall's tau(b)=0.54, p<0.001), behaviours (tau(b)=0.41, p=0.001), and overall score (tau(b)=0.51, p<0.001). Better teams administered the essential drug 2½min more quickly (Mann-Whitney U, p<0.001). CONCLUSIONS: The clinical conduct of a simulated emergency was strongly linked to generic measures of teamwork. Further studies are needed to elucidate which aspects of team working are critical for team performance, to better inform training programs for multi-professional team working.

Observations from 450 shoulder dystocia simulations: lessons for skills training.

Poor neonatal outcomes after shoulder dystocia have been associated with inappropriate management. Until there are significant developments in the prediction and subsequent prevention of shoulder dystocia, improving shoulder dystocia management through practical training may be the most effective method of reducing the associated morbidity and mortality. Four hundred fifty simulated shoulder dystocia scenarios, managed by 95 midwives and 45 doctors from six U.K. hospitals during the course of 1 year, were video recorded during a study of obstetric emergency training. Analysis of recorded data revealed that, before training, 57% were unable to deliver the baby, almost two thirds failed to call for pediatric support, and 1 in 27 used fundal pressure. Recurring difficulties in management were observed: poor communication, inability to gain internal access, confusion over internal maneuvers, and the application of excessive traction. Significant improvements in management were observed after training and persisted up to 1 year after training. The lessons learned from this study can inform and improve future training and management. This article describes difficulties encountered by the participants and discusses how training may be focused to address these problems.