Delivering high reliability in maternity care: In situ simulation as a source of organisational resilience

© 2016 Elsevier Ltd The fields of resilience engineering and high reliability organising both seek to explain the key sources and characteristics of safety in organisations that operate under conditions of considerable complexity, variability and surprise. A key focus in both of these fields is explaining how organisations can use adaptive and flexible work processes to deliver safe and reliable services, and how organisations can draw on past events and new experiences to increase their capacity to handle disruptive and unexpected events. To explore these issues, this paper develops an analysis of the routine use of on-site or ‘in situ’ simulation of emergency events as part of a systematic approach to safety management in the healthcare setting of maternity care. This analysis identifies three core organising processes through which in situ simulation can act as a source of organisational safety: relational rehearsal, system structuring and practice elaboration. We use this analysis to examine the opportunities that exist to develop more integrated explanatory accounts of high reliability organising and resilience engineering, particularly exploring the tensions between organisational stability and change, proactive and reactive modes of organising, and organisational strength and weakness

Impacted fetal head at caesarean section:a national survey of practice and training

This is a national survey of UK obstetric trainees and consultant labour ward leads designed to investigate the current practice and training for an impacted foetal head (IFH) at Caesarean Section (CS). An anonymous, on-line survey was disseminated to trainees via Postgraduate Schools and RCOG trainee representatives, and to labour ward leads via their national network. Three hundred and forty-five obstetric trainees and consultants responded. The results show that IFH is variably defined and encountered by most UK obstetricians (98% had encountered IFH and 76% had experienced it before full cervical dilatation). There is significant variation in management strategies, although most respondents would use a vaginal push up to assist delivery prior to reverse breech extraction. Responses revealed a paucity of training and lack of confidence in disimpaction techniques: over one in ten respondents had not received any training for IFH and less than half had received instruction in reverse breech extraction.Impact statement What is already known on the subject? IFH is an increasingly recognised, technically challenging complication of intrapartum CS. A recent report suggested that birth injuries associated with IFH are now as common as with shoulder dystocia. However, there is no consensus nor guidelines regarding the best practice for management or training. What do the results of this study add? This study demonstrates that IFH is poorly defined and commonly encountered by UK obstetricians. It highlights that IFH is not restricted to CS at full dilatation and reveals the ubiquity of the vaginal push method in UK practice. We found evidence that UK obstetricians are using techniques which have not been investigated and are not recommended for managing an IFH. Moreover, this survey is an eye-opener as to the paucity of training, highlighting that UK obstetric trainees are not adequately prepared to manage this emergency. What are the implications of these findings for clinical practice and/or further research? There is a pressing need to standardise the definition, guidance and training for IFH at CS. Further research should clarify the appropriate techniques for IFH and establish consensus for the best practice. An evidence-based simulation training package, which allows clinicians to learn and practice recognised disimpaction techniques is urgently required

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

Hypoxic-ischemic brain injury:Planned delivery before intrapartum events

BACKGROUND:Mothers are increasingly given greater control over many of the choices around birth, although there is little robust evidence to inform these choices. After an infant is born with HIE the question of whether it was predictable, or preventable, is often raised. Intrapartum ‘sentinel’ events and antenatal predictors of HIE have been well described, however there is little evidence how antenatal and intrapartum factors interact. This is particularly important when elective delivery by lower segment caesarean section (LSCS) has been shown to be beneficial in high risk groups. AIM:To develop a clinical risk score to identify women with a higher risk of having an infant with HIE. PATIENTS AND METHODS:This study is based on the Avon Longitudinal Study of Parents and Children (ALSPAC). This dataset was split into two halves: with each infant being randomly allocated to either cohort one or two. The first cohort was used for the derivation of the model, while it was tested exclusively on the second. Logistic regression modelling was then performed to develop a predictive model. The final model was used to predict the outcome of infants in the second cohort and infants divided into four risk quartiles. To give some indication of possible avoidable disease, the proportion of infants with HIE, potentially avoided by earlier delivery, was estimated by assuming that medicalized delivery by elective LSCS at 37 weeks would remove intrapartum risk of HIE for those infants undelivered at this point. RESULTS:In the final model seven covariates remained (parity, preeclampsia, polyhydramnios, prelabor rupture of membranes, gender, concerns over fetal growth and prematurity). When applied to the second cohort, a ROC curve for the prediction of developing HIE in the newborn period showed good evidence for association (AUC 0.68 (0.60 to 0.77)) and the risk score derived was strongly associated with the risk of HIE, resuscitation and stillbirth, and neonatal death (all p < 0.05). Elective delivery of high risk infants at 37 weeks gestation could prevent 14% of all HIE, with a NNT of 41. CONCLUSION:It is possible to combine routine antenatal findings to identify infants at higher risk of neonatal HIE, thereby recognizing those infants who may benefit most from delivery by elective caesarean section. This work suggests a clinical risk score permits antenatal identification of high-risk infants whose outcome may be amenable to changes in clinical practice to potentially reduce HIE rates, and its devastating consequences

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

How to be a very safe maternity unit: An ethnographic study.

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

IMproving the practice of intrapartum electronic fetal heart rate MOnitoring with cardiotocography for safer childbirth (the IMMO programme): protocol for a qualitative study.

INTRODUCTION: Suboptimal electronic fetal heart rate monitoring (EFM) in labour using cardiotocography (CTG) has been identified as one of the most common causes of avoidable harm in maternity care. Training staff is a frequently proposed solution to reduce harm. However, current approaches to training are heterogeneous in content and format, making it difficult to assess effectiveness. Technological solutions, such as digital decision support, have not yet demonstrated improved outcomes. Effective improvement strategies require in-depth understanding of the technical and social mechanisms underpinning the EFM process. The aim of this study is to advance current knowledge of the types of errors, hazards and failure modes in the process of classifying, interpreting and responding to CTG traces. This study is part of a broader research programme aimed at developing and testing an intervention to improve intrapartum EFM. METHODS AND ANALYSIS: The study is organised into two workstreams. First, we will conduct observations and interviews in three UK maternity units to gain an in-depth understanding of how intrapartum EFM is performed in routine clinical practice. Data analysis will combine the insights of an ethnographic approach (focused on the social norms and interactions, values and meanings that appear to be linked with the process of EFM) with a systems thinking approach (focused on modelling processes, actors and their interactions). Second, we will use risk analysis techniques to develop a framework of the errors, hazards and failure modes that affect intrapartum EFM. ETHICS AND DISSEMINATION: This study has been approved by the West Midlands-South Birmingham Research Ethics Committee, reference number: 18/WM/0292. Dissemination will take the form of academic articles in peer-reviewed journals and conferences, along with tailored communication with various stakeholders in maternity care

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

Significant intraventricular hemorrhage is more likely in very preterm infants born by vaginal delivery:a multi-centre retrospective cohort study

Objectives: The objective of this study is to determine the association between mode of delivery (vaginal delivery [VD] versus cesarean section [CS]) and the rate of significant intraventricular hemorrhage (sIVH) in preterm infants. Methods: A multicenter retrospective cohort study, based on data collected from the Vermont Oxford Network database. Infants born between 23 and 31+6 weeks of gestational age between 2001 and 2014 were identified. Exposure was the mode of birth (VD versus CS). Primary outcome was development of sIVH. Data were analyzed using univariate and multivariate statistical methods. Results: A total of 1575 infants were eligible. Nine hundred and two infants were born by CS and 673 by VD. Univariable analysis showed that infants born vaginally were more likely to have sIVH (p < .001), die before discharge (p < .001), have a composite poor outcome (death, sIVH or PVL), need oxygen therapy at 36-week corrected gestation (p = .010) and have a longer hospital stay (p = .006). After adjusting for available confounders, multivariable analysis persistently showed that infants between 23 and 27 weeks born by CS were less likely to develop sIVH [OR 1.61 (1.01–2.58), p = .049]. Conclusions: sIVH is less common in very preterm infants (23–27 weeks of gestation) delivered by CS. However, neurodevelopmental risks associated with survival at this early age, as well as increased maternal morbidities must also be considered