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Introduction: Environmental factors in the operating room during cesarean sections are likely important for both women/birthing people and their babies but there is currently a lack of rigorous literature about their evaluation. The principal aim of this study was to systematically examine studies published on the physical environment in the obstetrical operating room during c-sections and its impact on mother and neonate outcomes. The secondary objective was to identify the sensors used to investigate the operating room environment during cesarean sections., Methods: In this literature review, we searched MEDLINE a database using the following keywords: Cesarean section AND (operating room environment OR Noise OR Music OR Video recording OR Light level OR Gentle OR Temperature OR Motion Data). Eligible studies had to be published in English or French within the past 10 years and had to investigate the operating room environment during cesarean sections in women. For each study we reported which aspects of the physical environment were investigated in the OR (i.e., noise, music, movement, light or temperature) and the involved sensors., Results: Of a total of 105 studies screened, we selected 8 articles from title and abstract in PubMed. This small number shows that the field is poorly investigated. The most evaluated environment factors to date are operating room noise and temperature, and the presence of music. Few studies used advanced sensors in the operating room to evaluate environmental factors in a more nuanced and complete way. Two studies concern the sound level, four concern music, one concerns temperature and one analyzed the number of entrances/exits into the OR. No study analyzed light level or more fine-grained movement data., Conclusions: Main findings include increase of noise and motion at specific time-points, for example during delivery or anaesthesia; the positive impact of music on parents and staff alike; and that a warmer theatre is better for babies but more uncomfortable for surgeons., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Triboelectric nanogenerators (TENGs) have emerged as a promising green technology to efficiently harvest otherwise wasted mechanical energy from the environment and human activities. However, cost-effective and reliably performing TENGs require rational integration of triboelectric materials, spacers, and electrodes. The present work reports for the first time the use of oxydation-resistant pure copper nanowires (CuNWs) as an electrode to develop a flexible, and inexpensive TENG through a potentially scalable approach involving vacuum filtration and lactic acid treatment. A ∼6 cm 2 device yields a remarkable open circuit voltage ( V oc ) of 200 V and power density of 10.67 W m -2 under human finger tapping. The device is robust, flexible and noncytotoxic as assessed by stretching/bending maneuvers, corrosion tests, continuous operation for 8000 cycles, and biocompatibility tests using human fibroblast cells. The device can power 115 light emitting diodes (LEDs) and a digital calculator; sense bending and motion from the human hand; and transmit Morse code signals. The robustness, flexibility, transparency, and non-cytotoxicity of the device render it particularly promising for a wide range of energy harvesting and advanced healthcare applications, such as sensorised smart gloves for tactile sensing, material identification and safer surgical intervention.

Objective: To assess the impact of maternal Coronavirus disease 2019 (COVID-19) infection on placental histopathological findings in an unselected population and evaluate the potential effect on the fetus, including the possibility of vertical transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)., Design: Retrospective cohort comparative study of placental histopathological findings in patients with COVID-19, compared with controls., Setting: During the COVID-19 pandemic, placentas were studied from women at University College Hospital London who reported and/or tested positive for COVID-19., Population: Of 10 508 deliveries, 369 (3.5%) women had COVID-19 during pregnancy, with placental histopathology available for 244 women., Methods: Retrospective review of maternal and neonatal characteristics, where placental analysis had been performed. This was compared with available, previously published, histopathological findings from placentas of unselected women., Main Outcome Measures: Frequency of placental histopathological findings and relevant clinical outcomes., Results: Histological abnormalities were reported in 117 of 244 (47.95%) cases, with the most common diagnosis being ascending maternal genital tract infection. There was no statistically significant difference in the frequency of most abnormalities compared with controls. There were four cases of COVID-19 placentitis (1.52%, 95% CI 0.04%-3.00%) and one possible congenital infection, with placental findings of acute maternal genital tract infection. The rate of fetal vascular malperfusion (FVM), at 4.5%, was higher compared with controls (p = 0.00044)., Conclusions: In most cases, placentas from pregnant women infected with SARS-CoV-2 virus do not show a significantly increased frequency of pathology. Evidence for transplacental transmission of SARS-CoV-2 is lacking from this cohort. There is a need for further study into the association between FVM, infection and diabetes., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Advanced interfacial engineering has the potential to enable the successful realization of three features that are particularly important for a variety of healthcare applications: wettability control, antimicrobial activity to reduce infection risks, and sensing of physiological parameters. Here, a sprayable multifunctional triboelectric coating is exploited as a nontoxic, ultrathin tactile sensor that can be integrated directly on the fingertips of surgical gloves. The coating is based on a polymer blend mixed with zinc oxide (ZnO) nanoparticles, which enables antifouling and antibacterial properties. Additionally, the nanocomposite is superhydrophobic (self-cleaning) and is not cytotoxic. The coating is also triboelectric and can be applied directly onto surgical gloves with printed electrodes. The sensorized gloves so obtained enable mechanical energy harvesting, force sensing, and detection of materials stiffness changes directly from fingertip, which may complement proprioceptive feedback for clinicians. Just as importantly, the sensors also work with a second glove on top offering better reassurance regarding sterility in interventional procedures. As a case study of clinical use for stiffness detection, the sensors demonstrate successful detection of pig anal sphincter injury ex vivo. This may lead to improving the accuracy of diagnosing obstetric anal sphincter injury, resulting in prompt repair, fewer complications, and improved quality of life., (© 2023 The Authors. Advanced Healthcare Materials published by Wiley-VCH GmbH.)

Around half of the two million stillbirths occurring worldwide each year are preventable. This review compiles the most up-to-date evidence to inform stillbirth prevention. Many general maternal health interventions also reduce the risk of stillbirth, for example, antenatal care attendance. This review focuses on specific aspects of care: glucose metabolism, targeted aspirin prophylaxis, clotting and immune disorders, sleep positions, fetal movement monitoring, and preconception and interconception health. In the past few years, covid-19 infection during pregnancy has emerged as a risk factor for stillbirth, particularly among women who were not vaccinated. Alongside prevention, efforts to address stillbirth must include provision of high quality, supportive, and compassionate bereavement care to improve parents' wellbeing. A growing body of evidence suggests beneficial effects for parents who received supportive care and were offered choices such as mode of birth and the option to see and hold their baby. Staff need support to be able to care for parents effectively, yet, studies consistently highlight the scarcity of specific bereavement care training for healthcare providers. Action is urgently needed and is possible. Action must be taken with the evidence available now, in healthcare settings with high or low resources, to reduce stillbirths and improve training and care., Competing Interests: Competing interests: We have read and understood the BMJ policy on declaration of interests and declare the following interests: BA was secretary and DS co-chair of the Bereavement Working Group of the International Stillbirth Alliance during the writing of this review. BA, DS, and ZM are co-leads on the SUPPORT bereavement care course, which is discussed in the review., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Caesarean section (CS) is widely perceived as protective against obstetric brachial plexus injury (BPI), but few studies acknowledge the factors associated with such injury. The objectives of this study were therefore to aggregate cases of BPI after CS, and to illuminate risk factors for BPI., Methods: Pubmed Central, EMBASE and MEDLINE databases were searched using free text: ("brachial plexus injury" or "brachial plexus injuries" or "brachial plexus palsy" or "brachial plexus palsies" or "Erb's palsy" or "Erb's palsies" or "brachial plexus birth injury" or "brachial plexus birth palsy") and ("caesarean" or "cesarean" or "Zavanelli" or "cesarian" or "caesarian" or "shoulder dystocia"). Studies with clinical details of BPI after CS were included. Studies were assessed using the National Institutes for Healthy Study Quality Assessment Tool for Case Series, Cohort and Case-Control Studies., Main Results: 39 studies were eligible. 299 infants sustained BPI after CS. 53% of cases with BPI after CS had risk factors for likely challenging handling/manipulation of the fetus prior to delivery, in the presence of considerable maternal or fetal concerns, and/or in the presence of poor access due to obesity or adhesions., Conclusions: In the presence of factors that would predispose to a challenging delivery, it is difficult to justify that BPI could occur due to in-utero, antepartum events alone. Surgeons should exercise care when operating on women with these risk factors., (© 2023. The Author(s).)

Background: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority., Objectives: To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth., Search Strategy: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021., Selection Criteria: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention., Data Collection and Analysis: Interventions, outcomes reported, definitions and outcome measurement tools were extracted., Main Results: Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome., Conclusions: Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: 98% of stillbirths occur in low- and middle- income countries. Obstructed labor is a common cause for both neonatal and maternal mortality, with a lack of skilled birth attendants one of the main reasons for the reduction in operative vaginal birth, especially in low- and middle- income countries. We introduce a low cost, sensorized, wearable device for digital vaginal examination to facilitate accurate assessment of fetal position and force applied to the fetal head, to aid training in safe operative vaginal birth., Methods: The device consists of flexible pressure/force sensors mounted onto the fingertips of a surgical glove. Phantoms of the neonatal head were developed to replicate sutures. An Obstetrician tested the device on the phantoms by performing a mock vaginal examination at full dilatation. Data was recorded and signals interpreted. Software was developed so that the glove can be used with a simple smartphone app. A patient and public involvement panel was consulted on the glove design and functionality., Results: The sensors achieved a 20 Newton force range and a 0.1 Newton sensitivity, leading to 100% accuracy in detecting fetal sutures, including when different degrees of molding or caput were present. They also detected sutures and force applied with a second sterile surgical glove on top. The software developed allowed a force threshold to be set, alerting the clinician when excessive force is applied. Patient and public involvement panels welcomed the device with great enthusiasm. Feedback indicated that women would accept, and prefer, clinicians to use the device if it could improve safety and reduce the number of vaginal examinations required., Conclusion: Under phantom conditions to simulate the fetal head in labor, the novel sensorized glove can accurately determine fetal sutures and provide real-time force readings, to support safer clinical training and practice in operative birth. The glove is low cost (approximately 1 USD). Software is being developed so fetal position and force readings can be displayed on a mobile phone. Although substantial steps in clinical translation are required, the glove has the potential to support efforts to reduce the number of stillbirths and maternal deaths secondary to obstructed labor in low- and -middle income countries., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Jaufuraully, Salvadores Fernandez, Bagchi, Gupta, Desjardins, Siassakos, David and Tiwari.)

Background: Magnetic resonance imaging (MRI) provides excellent soft tissue visualisation which may be useful in late pregnancy to predict labour outcome and maternal/neonatal birth trauma., Objective: To study if MRI in late pregnancy can predict maternal and neonatal outcomes of labour and birth., Methods: Systematic review of studies that performed MRI in late pregnancy or immediately postpartum. Studies were included if they imaged maternal pelvic or neonatal structures and assessed birth outcome. Meta-analysis was not performed due to the heterogeneity of studies., Results: Eighteen studies were selected. Twelve studies explored the value of MRI pelvimetry measurement and its utility to predict cephalopelvic disproportion (CPD) and vaginal breech birth. Four explored cervical imaging in predicting time interval to birth. Two imaged women in active labour and assessed mouldability of the fetal skull. No marker of CPD had both high sensitivity and specificity for predicting labour outcome. The fetal pelvic index yielded sensitivities between 59 and 60%, and specificities between 34 to 64%. Similarly, although the sensitivity of the cephalopelvic disproportion index in predicting labour outcome was high (85%), specificity was only 56%. In women with breech presentation, MRI was demonstrated to reduce the rates of emergency caesarean section from 35 to 19%, and allowed better selection of vaginal breech birth. Live birth studies showed that the fetal head undergoes a substantial degree of moulding and deformation during cephalic vaginal birth, which is not considered during pelvimetry. There are conflicting studies on the role of MRI in cervical imaging and predicting time interval to birth., Conclusion: MRI is a promising imaging modality to assess aspects of CPD, yet no current marker of CPD accurately predicts labour outcome. With advances in MRI, it is hoped that novel methods can be developed to better identify individuals at risk of obstructed or pathological labour. Its role in exploring fetal head moulding as a marker of CPD should be further explored., (© 2022. The Author(s).)

Communication is associated with a significant percentage of errors or omissions in secondary healthcare across specialities; it is also the core process in and through which medical teams manage tasks, establish a rhythm and relationship between themselves and the patient, all of which are critical components of clinical practice. Despite this, however, communication is framed in medical training and the literature in either narrow terms or in a broad and fuzzy way, and it is indicative of the issue that teamwork and team communication are perceived and treated separately. In this paper, we draw on completed and ongoing interdisciplinary work to show how teams interact through illustrative examples from a large project on the management of obstetric emergencies. We provide a brief overview of the limitations in current tools and approaches, and we show how research under disciplines that have a long tradition in the analysis of interaction, and particularly healthcare sociolinguistics, can be translated and make a solid contribution to medical research and training., Competing Interests: Declaration of competing interest The authors have no conflicts of interest., (Copyright © 2022. Published by Elsevier Ltd.)

Objectives: In the UK one in 250 pregnancies end in stillbirth. Abnormal placental villous maturation, commonly associated with gestational diabetes, is a risk factor for stillbirth. Histopathology reports of placental distal villous immaturity (DVI) are reported disproportionately in placentas from otherwise unexplained stillbirths in women without formal diagnosis of diabetes but with either clinical characteristics or risk factors for diabetes. This study aims to establish maternal factors associated with DVI in relation to stillbirth., Methods: Placental histopathology reports were reviewed for all pregnant women delivering at University College London Hospital between July 2018 to March 2020. Maternal characteristics and birth outcomes of those with DVI were compared to those with other placental lesions or abnormal villous maturation., Results: Of the 752 placental histopathology reports reviewed, 11 (1.5%) were reported as diagnostic of DVI. Eighty cases were sampled for clinical record analysis. All women with DVI had normal PAPP-A (>0.4 MoM), normal uterine artery Doppler studies (UtA-PI) and were normotensive throughout pregnancy. Nearly one in five babies (2/11, 18.5%) with DVI were stillborn and 70% had at least one high glucose test result in pregnancy despite no formal diagnosis of diabetes., Conclusions: These findings suggest that the mechanism underlying stillbirth in DVI likely relates to glucose dysmetabolism, not sufficient for diagnosis using current criteria for gestational diabetes, resulting in placental dysfunction that is not identifiable before the third trimester. Relying on conventional diabetes tests, foetal macrosomia or growth restriction, may not identify all pregnancies at risk of adverse outcomes from glucose dysmetabolism., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Background: A maternal postpartum 6-week check (SWC) with a general practitioner (GP) is now considered an essential service in England, a recent policy change intended to improve women's health. We aimed to provide an up-to-date snapshot of the prevalence of SWC prior to the policy change as a baseline, and to explore factors associated with having a late or no check., Methods: We conducted a cohort study using primary care records in England (Clinical Practice Research Datalink (CPRD)). 34 337 women who gave birth between 1 July 2015 and 30 June 2018 and had ≥12 weeks of follow-up post partum were identified in the CPRD Pregnancy Register. The proportion who had evidence of an SWC with a GP was calculated, and regression analysis was used to assess the association between women's characteristics and risks of a late or no check., Results: Sixty-two per cent (95% CI 58% to 67%) of women had an SWC recorded at their GP practice within 12 weeks post partum, another 27% had other consultations. Forty per cent had an SWC at the recommended 6-8 weeks, 2% earlier and 20% later. A late or no check was more common among younger women, mothers of preterm babies or those registered in more deprived areas., Conclusions: Nearly 40% of women did not have a postpartum SWC recorded. Provision or uptake was not equitable; younger women and those in more deprived areas were less likely to have a record of such check, suggesting postpartum care in general practice may be missing some women who need it most., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: Around 60,000 babies are born preterm (prior to 37 weeks' gestation) each year in the UK. There is little evidence on the optimal birth mode (vaginal or caesarean section)., Objective: The overall aim of the CASSAVA project was to determine if a trial to define the optimal mode of preterm birth could be carried out and, if so, determine what sort of trial could be conducted and how it could best be performed. We aimed to determine the specific groups of preterm women and babies for whom there are uncertainties about the best planned mode of birth, and if there would be willingness to recruit to, and participate in, a randomised trial to address some, but not all, of these uncertainties. This project was conducted in response to a Heath Technology Assessment programme commissioning call (17/22 'Mode of delivery for preterm infants')., Methods: We conducted clinician and patient surveys ( n  = 224 and n  = 379, respectively) to identify current practice and opinion, and a consensus survey and Delphi workshop ( n  = 76 and n  = 22 participants, respectively) to inform the design of a hypothetical clinical trial. The protocol for this clinical trial/vignette was used in telephone interviews with clinicians ( n  = 24) and in focus groups with potential participants ( n  = 13)., Results: Planned sample size and data saturation was achieved for all groups except for focus groups with participants, as this had to be curtailed because of the COVID-19 pandemic and data saturation was not achieved. There was broad agreement from parents and health-care professionals that a trial is needed. The clinician survey demonstrated a variety of practice and opinion. The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants. The interactive workshop and Delphi consensus process confirmed the need for more evidence (hence the case for a trial) and provided rich information on what a future trial should entail. It was agreed that any trial should address the areas with most uncertainty, including the management of women at 26-32 weeks' gestation, with either spontaneous preterm labour (cephalic presentation) or where preterm birth was medically indicated. Clear themes around the challenges inherent in conducting any trial emerged, including the concept of equipoise itself. Specific issues were as follows: different clinicians and participants would be in equipoise for each clinical scenario, effective conduct of the trial would require appropriate resources and expertise within the hospital conducting the trial, potential participants would welcome information on the trial well before the onset of labour and minority ethnic groups would require tailored approaches., Conclusion: Given the lack of evidence and the variation of practice and opinion in this area, and having listened to clinicians and potential participants, we conclude that a trial should be conducted and the outlined challenges resolved., Future Work: The CASSAVA project could be used to inform the design of a randomised trial and indicates how such a trial could be carried out. Any future trial would benefit from a pilot with qualitative input and a study within a trial to inform optimal recruitment., Limitations: Certainty that a trial could be conducted can be determined only when it is attempted., Trial Registration: Current Controlled Trials ISRCTN12295730., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 61. See the NIHR Journals Library website for further project information.

Background: Stillbirth, the death of a baby before birth, is associated with significant psychological and social consequences that can be mitigated by respectful and supportive bereavement care. The absence of high-level evidence to support the broad scope of perinatal bereavement practices means that offering a range of options identified as valued by parents has become an important indicator of care quality. This study aimed to describe bereavement care practices offered to parents across different high-income and middle-income countries., Methods: An online survey of parents of stillborn babies was conducted between December 2014 and February 2015. Frequencies of nine practices were compared between high-income and middle-income countries. Differences in proportions of reported practices and their associated odds ratios were calculated to compare high-income and middle-income countries., Results: Over three thousand parents (3041) with a self-reported stillbirth in the preceding five years from 40 countries responded. Fifteen countries had atleast 40 responses. Significant differences in the prevalence of offering nine bereavement care practices were reported by women in high-income countries (HICs) compared with women in middle-income countries (MICs). All nine practices were reported to occur significantly more frequently by women in HICs, including opportunity to see and hold their baby (OR = 4.8, 95% CI 4.0-5.9). The widespread occurrence of all nine practices was reported only for The Netherlands., Conclusions: Bereavement care after stillbirth varies between countries. Future research should look at why these differences occur, their impact on parents, and whether differences should be addressed, particularly how to support effective communication, decision-making, and follow-up care., (© 2021 Wiley Periodicals LLC.)

Objective: To compare intramuscular oxytocin, Syntometrine ® and carbetocin for prevention of postpartum haemorrhage after vaginal birth., Design: Randomised double-blinded clinical trial., Setting: Six hospitals in England., Population: A total of 5929 normotensive women having a singleton vaginal birth., Methods: Randomisation when birth was imminent., Main Outcome Measures: Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, adverse effects, quality of life., Results: Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (odds ratio [OR] 1.28, 95% CI 1.08-1.51, P = 0.004); the difference between carbetocin and oxytocin was non-significant (P = 0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P = 0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0.64, 95% CI 0.42-0.97) but not carbetocin (P = 0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal adverse effects and reduced ability of the mother to bond with her baby., Conclusions: Non-inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal adverse effects are a disadvantage of Syntometrine., Tweetable Abstract: IM carbetocin does not reduce additional uterotonic use compared with IM Syntometrine or oxytocin., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objective: To assess the impact of type of bariatric surgery on pregnancy outcomes., Study Design: This is a national prospective observational study using the UK Obstetric Surveillance System (UKOSS). Data collection was undertaken in 200 consultant-led NHS maternity units between November 2011 and October 2012 (gastric banding), and April 2014 and March 2016 (gastric bypass and sleeve gastrectomy). Participants were pregnant women following gastric banding (n = 127), gastric bypass (n = 134) and sleeve gastrectomy (n = 29). Maternal and perinatal outcomes were compared using generalised linear and linear mixed models. Maternal outcomes included gestational weight gain, pre-eclampsia, gestational diabetes, anaemia, surgical complications. Perinatal outcomes included birthweight, small/large for gestational age (SGA/LGA), preterm birth, stillbirth., Results: Maternal: Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of anaemia compared with gastric bypass (banding (16 %) vs bypass (39 %): p = 0.002, sleeve (21 %) vs bypass: p = 0.04). Gestational diabetes risk was lower after gastric banding compared with gastric bypass (7 % vs 16 %, p = 0.03) despite women with banding having significantly greater weight at booking as well as gestational weight gain. Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of surgical complications than after gastric bypass (banding (0.9 %) vs bypass (11.4 %): p = 0.03, sleeve (0.0 %) vs bypass: p = 0.06). Perinatal: Infants born to mothers after gastric banding had a higher birthweight than those born to mothers after gastric bypass (mean difference = 260 g (125-395), p < 0.001). Infants were more likely to be LGA if their mothers had gastric banding compared with gastric bypass or sleeve gastrectomy (banding (21 %) vs bypass (5 %): p = 0.006; banding vs sleeve (3 %): p = 0.03). Risk of preterm birth was higher in women with gastric banding compared with gastric bypass (13 % vs 8 %, p = 0.04)., Conclusions: Women planning bariatric surgery should be counselled regarding the differing impacts of different types of procedure on any future pregnancy. Pre-existing gastric bypass is associated with higher rates of potentially serious surgical complications during pregnancy., Competing Interests: Declaration of Competing Interest The authors report no declarations of interest., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: When a formal review of care takes places after the death of a baby, parents are largely unaware it takes place and are often not meaningfully involved in the review process. Parent engagement in the process is likely to be essential for a successful review and to improve patient safety. This study aimed to evaluate an intervention process of parental engagement in perinatal mortality review (PNMR) and to identify barriers and facilitators to its implementation., Design: Mixed-methods study of parents' engagement in PNMR., Setting: Single tertiary maternity unit in the UK., Participants: Bereaved parents and healthcare professionals (HCPs)., Interventions: Parent engagement in the PNMR (intervention) was based on principles derived through national consensus and qualitative research with parents, HCPs and stakeholders in the UK., Outcomes: Recruitment rates, bereaved parents and HCPs' perceptions., Results: Eighty-one per cent of bereaved parents approached (13/16) agreed to participate in the study. Two focus groups with bereaved parents (n=11) and HCP (n=7) were carried out postimplementation to investigate their perceptions of the process.Overarching findings were improved dialogue and continuity of care with parents, and improvements in the PNMR process and patient safety. Bereaved parents agreed that engagement in the PNMR process was invaluable and helped them in their grieving. HCP perceived that parent involvement improved the review process and lessons learnt from the deaths; information to understand the impact of aspects of care on the baby's death were often only found in the parents' recollections., Conclusions: Parental engagement in the PNMR process is achievable and useful for parents and HCP alike, and critically can improve patient safety and future care for mothers and babies. To learn and prevent perinatal deaths effectively, all hospitals should give parents the option to engage with the review of their baby's death., Competing Interests: Competing interests: Authors include the chair and members of the national Perinatal Mortality Review Tool (PMRT) group., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Parent engagement in perinatal mortality review meetings following stillbirth may benefit parents and improve patient safety. We investigated perinatal mortality review meeting practices, including the extent of parent engagement, based on self-reports from healthcare professionals from maternity care facilities in six high-income countries., Design: Cross-sectional online survey., Setting: Australia, Canada, Ireland, New Zealand, UK and USA., Population: A total of 1104 healthcare professionals, comprising mainly obstetricians, gynaecologists, midwives and nurses., Methods: Data were drawn from responses to a survey covering stillbirth-related topics. Open- and closed-items that focused on 'Data quality on causes of stillbirth' were analysed., Main Outcome Measures: Healthcare professionals' self-reported practices around perinatal mortality review meetings following stillbirth., Results: Most clinicians (81.0%) were aware of regular audit meetings to review stillbirth at their maternity facility, although this was true for only 35.5% of US respondents. For the 854 respondents whose facility held regular meetings, less than a third (31.1%) reported some form of parent engagement, and this was usually in the form of one-way post-meeting feedback. Across all six countries, only 17.1% of respondents described an explicit approach where parents provided input, received feedback and were represented at meetings., Conclusions: We found no established practice of involving parents in the perinatal mortality review process in six high-income countries. Parent engagement may hold the key to important lessons for stillbirth prevention and care. Further understanding of approaches, barriers and enablers is warranted., Tweetable Abstract: Parent engagement in mortality review after stillbirth is rare, based on data from six countries. We need to understand the barriers., (© 2020 John Wiley & Sons Ltd.)

Background: How to best support pregnant women in making truly autonomous decisions which accord with current consent law is poorly understood and problematic for them and their healthcare professionals. This observational study examined a range of ante-natal consultations where consent for an intervention took place to determine key themes during the encounter., Methods: Qualitative research in a large urban teaching hospital in London. Sixteen consultations between pregnant women and their healthcare professionals (nine obstetricians and three midwives) where ante-natal interventions were discussed and consent was documented were directly observed. Data were collectively analysed to identify key themes characterising the consent process., Results: Four themes were identified: 1) Clinical framing - by framing the consultation in terms of the clinical decision to be made HCPs miss the opportunity to assess what really matters to a pregnant woman. For many women the opportunity to feel that their previous experiences had been 'heard' was an important but sometimes neglected prelude to the ensuing consultation; 2) Clinical risk dominated narrative - all consultations were dominated by information related to risk; discussion of reasonable alternatives was not always observed and women's understanding of information was seldom verified making compliance with current law questionable; 3) Parallel narrative - woman-centred experience - for pregnant women social factors such as the place of birth and partner influences were as or more important than considerations of clinical risk yet were often missed by HCPs; 4) Cross cutting narrative - genuine dialogue - we observed variably effective interaction between the clinical (2) and patient (3) narratives influenced by trust and empathy and explicit empowering language by HCPs., Conclusion: We found that ante-natal consultations that include consent for interventions are dominated by clinical framing and risk, and explore the woman-centred narrative less well. Current UK law requires consent consultations to include explicit effort to gauge a woman's preferences and values, yet consultations seem to fail to achieve such understanding. At the very least, consultations may be improved by the addition of opening questions along the lines of 'what matters to you most?'

Objective: To develop global consensus on a set of evidence-based core principles for bereavement care after stillbirth., Methods: A modified policy-Delphi methodology was used to consult international stakeholders and healthcare workers with experience in stillbirth between September 2017 and October 2018. Five sequential rounds involved two expert stakeholder meetings and three internet-based surveys, including a global internet-based survey targeted at healthcare workers in a wide range of settings., Results: Initially, 23 expert stakeholders considered 43 evidence-based themes derived from systematic reviews, identifying 10 core principles. The global survey received 236 responses from participants in 26 countries, after which nine principles met a priori criteria for inclusion. The final stakeholder meeting and internet-based survey of all participants confirmed consensus on eight core principles. Highest quality bereavement care should be enabled through training of healthcare staff to reduce stigma and establish respectful care, including acknowledgement and support for grief responses, and provision for physical and psychologic needs. Women and families should be supported to make informed choices, including those concerning their future reproductive health., Conclusion: Consensus was established for eight principles for stillbirth bereavement care. Further work should explore implementation and involve the voices of women and families globally., (© 2020 International Federation of Gynecology and Obstetrics.)

Objective: To assess whether the implementation of an intrapartum training package (PROMPT (PRactical Obstetric Multi-Professional Training)) across a health service reduced the proportion of term babies born with Apgar score <7 at 5 min (<7 5mins )., Design: Stepped-wedge cluster randomised controlled trial., Setting: Twelve randomised maternity units with ≥900 births/year in Scotland. Three additional units were included in a supplementary analysis to assess the effect across Scotland. The intervention commenced in March 2014 with follow-up until September 2016., Intervention: The PROMPT training package (Second edition), with subsequent unit-level implementation of PROMPT courses for all maternity staff., Main Outcome Measures: The primary outcome was the proportion of term babies with Apgar<7 5mins ., Results: 87 204 eligible births (99.2% with an Apgar score), of which 1291 infants had an Apgar<7 5mins were delivered in the 12 randomised maternity units. Two units did not implement the intervention. The overall Apgar<7 5mins rate observed in the 12 randomised units was 1.49%, increasing from 1.32% preintervention to 1.59% postintervention. Once adjusted for a secular time trend, the 'intention-to-treat' analysis indicated a moderate but non-significant reduction in the rate of term babies with an Apgar scores <7 5mins following PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). However, some units implemented the intervention earlier than their allocated step, whereas others delayed the intervention. The content and authenticity of the implemented intervention varied widely at unit level. When the actual date of implementation of the intervention in each unit was considered in the analysis, there was no evidence of improvement (OR=1.01 (0.84 to 1.22)). No intervention effect was detected by broadening the analysis to include all 15 large Scottish maternity units. Units with a history of higher rates of Apgar<7 5mins maintained higher Apgar rates during the study (OR=2.09 (1.28 to 3.41)) compared with units with pre-study rates aligned to the national rate., Conclusions: PROMPT training, as implemented, had no effect on the rate of Apgar <7 5mins in Scotland during the study period. Local implementation at scale was found to be more difficult than anticipated. Further research is required to understand why the positive effects observed in other single-unit studies have not been replicated in Scottish maternity units, and how units can be best supported to locally implement the intervention authentically and effectively., Trial Registration Number: ISRCTN11640515., Competing Interests: Competing interests: EL is an employee of the University of Bristol which receives funding from PROMPT charity to pay part of EL’s salary. CW is seconded from North Bristol NHS Trust as the Lead Research Midwife to the PROMPT charity. DS is an invited member of GLOBE, an initiative funded by Ferring. TD is a Trustee of the PROMPT Maternity Foundation charity, which provides PROMPT Training. He is a consultant for Limbs & Things and Laerdal and paid speaker for Ferring Pharmaceuticals. CW, DS and JC are members of the PROMPT Maternity Foundation charity. The remaining authors have no competing interests., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Post-partum haemorrhage (PPH) is the second greatest direct cause of maternal death in the United Kingdom, and rates of PPH continue to increase despite advances in clinical care. Training workers to manage PPH involves improvement of technical and non-technical skills in the context of a multidisciplinary team (MDT). Management of PPH should begin in the antenatal period, with identification of high-risk women and referral for multispecialty input. Training for the acute management of PPH should involve all members of the labour ward team and beyond, including haematology and non-clinical staff. Simulation-based training, didactic teaching and hybrid obstetric emergency courses are current options for training workers. Non-technical skills should also be taught, including specific training on communication, leadership, situational awareness and team-working skills. Improving management of obstetric emergencies requires thorough antenatal and intra-partum risk assessment, optimising knowledge and non-technical skills of individual members of the team, improving collaboration of the MDT, better simulation training and adjusting local infrastructure., (Copyright © 2019. Published by Elsevier Ltd.)

Background: Preparing healthcare providers to manage relatively rare life-threatening emergency situations effectively is a challenge. Training sessions enable staff to rehearse for these events and are recommended by several reports and guidelines. In this review we have focused on interactive training, this includes any element where the training is not solely didactic but provides opportunity for discussions, rehearsals, or interaction with faculty or technology. It is important to understand the effective methods and essential elements for successful emergency training so that resources can be appropriately targeted to improve outcomes., Objectives: To assess the effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital on patient outcomes, clinical care practices, or organisational practices, and to identify essential components of effective interactive emergency training programmes., Search Methods: We searched CENTRAL, MEDLINE, Embase, CINAHL and ERIC and two trials registers up to 11 March 2019. We searched references of included studies, conference proceedings, and contacted study authors., Selection Criteria: We included randomised trials and cluster-randomised trials comparing interactive training for emergency situations with standard/no training. We defined emergency situations as those in which immediate lifesaving action is required, for example cardiac arrests and major haemorrhage. We included all studies where healthcare workers involved in providing direct clinical care were participants. We excluded studies outside of a hospital setting or where the intervention was not targeted at practicing healthcare workers. We included trials irrespective of publication status, date, and language., Data Collection and Analysis: We used standard methodological procedures expected by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC) Group. Two review authors independently extracted data and assessed the risk of bias of each included trial. Due to the small number of studies and the heterogeneity in outcome measures, we were unable to perform the planned meta-analysis. We provide a structured synthesis for the following outcomes: survival to hospital discharge, morbidity rate, protocol or guideline adherence, patient outcomes, clinical practice outcomes, and organisation-of-care outcomes. We used the GRADE approach to rate the certainty of the evidence and the strength of recommendations for each outcome., Main Results: We included 11 studies that reported on 2000 healthcare providers and over 300,000 patients; one study did not report the number of participants. Seven were cluster randomised trials and four were single centre studies. Four studies focused on obstetric training, three on obstetric and neonatal care, two on neonatal training, one on trauma and one on general resuscitations. The studies were spread across high-, middle- and low-income settings.Interactive training may make little or no difference in survival to hospital discharge for patients requiring resuscitation (1 study; 30 participants; 98 events; low-certainty evidence). We are uncertain if emergency training changes morbidity rate, as the certainty of the evidence is very low (3 studies; 1778 participants; 57,193 patients, when reported). We are uncertain if training alters healthcare providers' adherence to clinical protocols or guidelines, as the certainty of the evidence is very low (3 studies; 156 participants; 558 patients). We are uncertain if there were improvements in patient outcomes following interactive training for emergency situations, as we assessed the evidence as very low-certainty (5 studies, 951 participants; 314,055 patients). We are uncertain if training for emergency situations improves clinical practice outcomes as the certainty of the evidence is very low (4 studies; 1417 participants; 28,676 patients, when reported). Two studies reported organisation-of-care outcomes, we are uncertain if interactive emergency training has any effect on this outcome as the certainty of the evidence is very low (634 participants; 179,400 patient population).We examined prespecified subgroups and found no clear commonalities in effect of multidisciplinary training, location of training, duration of the course, or duration of follow-up. We also examined areas arising from the studies including focus of training, proportion of staff trained, leadership of intervention, and incentive/trigger to participate, and again identified no clear mediating factors. The sources of funding for the studies were governmental, local organisations, or philanthropic donors., Authors' Conclusions: We are uncertain if there are any benefits of interactive training of healthcare providers on the management of life-threatening emergencies in hospital as the certainty of the evidence is very low. We were unable to identify any factors that may have allowed us to identify an essential element of these interactive training courses.We found a lack of consistent reporting, which contributed to the inability to meta-analyse across specialities. More trials are required to build the evidence base for the optimum way to prepare healthcare providers for rare life-threatening emergency events. These trials need to be conducted with attention to outcomes important to patients, healthcare providers, and policymakers. It is vitally important to develop high-quality studies adequately powered and with attention to minimising the risk of bias.

Background: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI., Objective: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds., Design: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved., Setting: Usual NHS care., Participants: Patients undergoing elective/non-elective abdominal surgery, including caesarean section., Interventions: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'., Main Outcome Measures: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers., Data Sources: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals., Results: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n  = 133; glue, n  = 129; no dressing, n  = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy ( c -statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments., Limitations: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres., Conclusions: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks., Trial Registration: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1)., Competing Interests: Chris A Rogers reports grants from the British Heart Foundation to April 2017, outside the submitted work. Chris A Rogers is a member of Clinical Trials Units funded by the National Institute for Health Research (NIHR) and the Health Technology Assessment (HTA) Commissioning Board. Melanie J Calvert reports personal fees from Ferring Pharmaceuticals (Saint-Prex, Switzerland), outside the submitted work. Rhiannon C Macefield has a patent Wound Healing Questionnaire pending to the University of Bristol. Stephen O’Brien reports grants from Saving Lives at Birth Partners, outside the submitted work. Tim Draycott reports personal fees from Ferring Pharmaceuticals, outside the submitted work. Barnaby C Reeves reports membership of the HTA Commissioning Board (up to 31 March 2016), the Systematic Reviews Programme Advisory Group (up to 5 July 2017) and Interventional Procedures Panel Methods Group, the HTA Efficient Study Designs Board, SRP – Cochrane Programme Grant Funding Meeting and Systematic Reviews NIHR Cochrane Incentive Awards (all current).

Background: Operative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth., Methods: The STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering., Discussion: The STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth., Trial Registration: ISRCTN11760611 05/03/2018 (retrospectively registered).

Manual rotation (MR) is the most common technique used by accoucheurs who wish to correct malposition of the foetal head to either avoid or facilitate an operative vaginal delivery (OVD). MR can be performed using either a whole-hand or a digital approach. MR should be formally taught and trainees should be assessed for competence, and later, performance should ideally be tracked with statistical control charts. There is paucity of robust evidence evaluating MR relative to the other methods of rotational OVD: rotational forceps (RF) and rotational ventouse (RV). Furthermore, there is little evidence concerning long-term maternal outcomes of rotational OVD. A prospective randomised trial of MR versus either RF or RV is clearly needed, along with a core outcome set for OVD to facilitate comprehensive evaluation programmes that focus on aspects pertaining to women., (Copyright © 2018. Published by Elsevier Ltd.)

Objective: Engaging bereaved parents in the review process that examines their care before and after a perinatal death might help parents deal with their grief more effectively and drive improvements in patient safety. The objective of this study is to explore whether healthcare professionals would accept or support parent engagement in the perinatal mortality review process., Design: Qualitative focus group interviews. Transcripts were analysed with an inductive thematic approach., Setting: Two geographically distinct tertiary maternity hospitals in the UK., Participants: Five focus groups were conducted with clinical staff including midwives, obstetricians, neonatologists, nursing staff and chaplaincy services., Results: Twenty-seven healthcare professionals unanimously agreed that parents' involvement in the perinatal mortality review process is useful and necessary. Six key themes emerged including: parental engagement; need for formal follow-up; critical structure of perinatal mortality review meeting; coordination and streamlining of care; advocacy for parents including role of the bereavement care lead; and requirement for training and support for staff to enable parental engagement., Conclusions: Healthcare professionals strongly advocated engaging bereaved parents in the perinatal mortality review: empowering parents to ask questions, providing feedback on care, helping generate lessons and providing them with the opportunity to discuss a summary of the review conclusions with their primary healthcare professional contact. The participants agreed it is time to move on from 'a group of doctors reviewing notes' to active learning and improvement together with parents, to enable better care and prevention of perinatal death., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

Background: Postpartum haemorrhage remains a major cause of maternal mortality and morbidity worldwide. Active management of the third stage of labour reduces the risk of postpartum haemorrhage. Oxytocin and oxytocin/ergometrine are commonly used in the UK, with oxytocin/ergometrine being more effective at preventing moderate, but not severe, blood loss. Many guidelines specifically recommend using oxytocin for all vaginal births, as it is associated with fewer adverse events. However, a survey conducted by the Southmead Hospital Maternity Research Team revealed that 71.4% of UK obstetric units still routinely use oxytocin/ergometrine. Carbetocin is a newer medication that may be as effective but has fewer side effects. No studies have directly compared all three medications., Methods: The IMox study aims to determine the most effective, acceptable and cost-effective drug for primary prevention of postpartum haemorrhage following vaginal birth. The IMox study is a prospective, multi-centre, double-blind, randomised trial directly comparing oxytocin, oxytocin/ergometrine and carbetocin given intramuscularly for the prevention of postpartum haemorrhage in the third stage of labour. The primary effectiveness outcome is the use of an additional uterotonic drug. Secondary effectiveness outcomes reflect maternal morbidity and mortality within the immediate postpartum period. Participant questionnaires and subjective reporting of side effects will be used to evaluate maternal acceptability. Maternal quality of life utilities will be collected antenatally, and on days 1 and 14 after birth to enable a cost-effectiveness assessment of each studied drug. Participants will be pregnant women planning a vaginal birth in six hospitals in England. Participants will be approached and invited to provide consent to participate from 20 weeks gestation until in established labour. A complete sample of 5712 participants (1904 per arm) providing data for the primary outcome will allow for a robust determination of efficacy between all three study drugs. Data will be collected until participants are discharged from the hospital and on postnatal days 1 and 14 regardless of location. All analyses will be on a modified intention-to-treat basis, and additionally repeated on a per protocol basis. Data collection commenced in Feburary 2015 and was completed in August 2018., Discussion: This study is the first to directly compare oxytocin, oxytocin/ergometrine and carbetocin in the same population for the prevention of postpartum haemorrhage following vaginal birth. Furthermore, this study will be the first to directly compute health economic outcomes from such a three-way comparison. This study is limited to using short-term outcomes, and so will not provide evidence for important outcomes such as long-term maternal psychological well-being and time to next conception., Trial Registration: ClinicalTrials.gov, NCT02216383 . Registered on 18 August 2014. EudraCT, 2014-001948-37. Registered on 23 September 2014. ISRCTN, ISRCTN10232550. Retrospectively registered on 6 March 2018).

Background: Stillbirth has a profound impact on women, families, and healthcare workers. The burden is highest in low- and middle-income countries (LMICs). There is need for respectful and supportive care for women, partners, and families after bereavement., Objective: To perform a qualitative meta-summary of parents' and healthcare professionals' experiences of care after stillbirth in LMICs., Search Strategy: Search terms were formulated by identifying all synonyms, thesaurus terms, and variations for stillbirth. Databases searched were AMED, EMBASE, MEDLINE, PsychINFO, BNI, CINAHL., Selection Criteria: Qualitative, quantitative, and mixed method studies that addressed parents' or healthcare professionals' experience of care after stillbirth in LMICs., Data Collection and Analysis: Studies were screened, and data extracted in duplicate. Data were analysed using the Sandelowski meta-summary technique that calculates frequency and intensity effect sizes (FES/IES)., Main Results: In all, 118 full texts were screened, and 34 studies from 17 countries were included. FES range was 15-68%. Most studies had IES 1.5-4.5. Women experience a broad range of manifestations of grief following stillbirth, which may not be recognised by healthcare workers or in their communities. Lack of recognition exacerbates negative experiences of stigmatisation, blame, devaluation, and loss of social status. Adequately developed health systems, with trained and supported staff, are best equipped to provide the support and information that women want after stillbirth., Conclusions: Basic interventions could have an immediate impact on the experiences of women and their families after stillbirth. Examples include public education to reduce stigma, promoting the respectful maternity care agenda, and investigating stillbirth appropriately., Tweetable Abstract: Reducing stigma, promoting respectful care and investigating stillbirth have a positive impact after stillbirth for women and families in LMICs., (© 2018 Royal College of Obstetricians and Gynaecologists.)

Background: Surgical procedures are complex and susceptible to human error. Individual surgical skill correlates with improved patient outcomes demonstrating that surgical proficiency is vitally important for patient safety. Evidence demonstrates that simulation training improves laparoscopic surgical skills; however, projects to implement and integrate laparoscopic simulation into core surgical curricula have had varied success. One barrier to successful implementation has been the lack of awareness and prioritisation of simulation initiatives by key stakeholders., Objective: To determine the knowledge and perceptions of patients and hospital managers on laparoscopic surgery and simulation training in patient safety and healthcare., Method: A qualitative study was conducted in the Southwest of England. 40 semistructured interviews were undertaken with patients attending general gynaecology clinics and general surgical and gynaecology hospital managers., Results: Six key themes identified included: positive expectations of laparoscopic surgery; perceptions of problems and financial implications of laparoscopic surgery; lack of awareness of difficulties with surgical training; desire for laparoscopic simulation training and competency testing for patient benefit; conflicting priorities of laparoscopic simulation in healthcare; and drawbacks of surgical simulation training. Patients and managers were largely unaware of the risks of laparoscopic surgery and challenges for training. Managers highlighted conflicting financial priorities when purchasing educational equipment. Patients stated that they would have greater confidence in a surgeon who had undertaken mandatory surgical simulation training and perceived purchasing simulation equipment to be a high priority in the National Health Services. Most patients and hospital managers believed trainees should pass an examination on a simulator prior to live operating., Conclusions: Competency-based mandatory laparoscopic simulation was strongly supported by the majority of stakeholders to augment the initial learning curve of surgeons., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Experiencing stillbirth is devastating and leaves parents searching for causes. Autopsy is the gold standard for investigation, but deciding to consent to this procedure is very difficult for parents. Decision support in the form of clear, consistent, and parent-centered information is likely to be helpful. The aims of this study were to understand the influences on parents' decisions about autopsy after stillbirth and to identify attributes of effective decision support that align with parents' needs., Methods: Framework analysis using the Decision Drivers Model was used to analyze responses from 460 Australian and New Zealand (ANZ) mothers who took part in a multi-country online survey of parents' experiences of stillbirth. The main outcomes examined were factors influencing mothers' decisions to consent to autopsy after stillbirth., Results: Free-text responses from 454 ANZ mothers referenced autopsy, yielding 1221 data segments for analysis. The data confirmed the difficult decision autopsy consent entails. Mothers had a strong need for answers coupled with a strong need to protect their baby. Four "decision drivers" were confirmed: preparedness for the decision; parental responsibility; possible consequences; and role of health professionals. Each had the capacity to influence decisions for or against autopsy. Also prominent were the "aftermath" of the decision: receiving the results; and decisional regret or uncertainty., Conclusions: The influences on decisions about autopsy are diverse and unpredictable. Effective decision support requires a consistent and structured approach that is built on understanding of parents' needs., (© 2018 Wiley Periodicals, Inc.)

Background: The perinatal mortality review meeting that takes place within the hospital following a stillbirth or neonatal death enables clinicians to learn vital lessons to improve care for women and their families for the future. Recent evidence suggests that parents are unaware that a formal review following the death of their baby takes place. Many would welcome the opportunity to feedback into the meeting itself. Parental involvement in the perinatal mortality review meeting has the potential to improve patient satisfaction, drive improvements in patient safety and promote an open culture within healthcare. Yet evidence on the feasibility of involving bereaved parents in the review process is lacking. This paper describes the protocol for the Parents' Active Role and Engangement iN the review of their Stillbirth/perinatal death study (PARENTS 2) , whereby healthcare professionals' and stakeholders' perceptions of parental involvement will be investigated, and parental involvement in the perinatal mortality review will be piloted and evaluated at two hospitals., Methods and Analysis: We will investigate perceptions of parental involvement in the perinatal mortality review process by conducting four focus groups. A three-round modified Delphi technique will be employed to gain a consensus on principles of parental involvement in the perinatal mortality review process. We will use three sequential rounds, including a national consensus meeting workshop with experts in stillbirth, neonatal death and bereavement care, and a two-stage anonymous online questionnaire. We will pilot a new perinatal mortality review process with parental involvement over a 6-month study period. The impact of the new process will be evaluated by assessing parents' experiences of their care and parents' and staff perceptions of their involvement in the process by conducting further focus groups and using a Parent Generated Index questionnaire., Ethics and Dissemination: This study has ethical approval from the UK Health Research Authority. We will disseminate the findings through national and international conferences and international peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Stillbirth is a global health problem. The World Health Organization (WHO) application of the International Classification of Diseases for perinatal mortality (ICD-PM) aims to improve data on stillbirth to enable prevention., Objectives: To identify globally reported causes of stillbirth, classification systems, and alignment with the ICD-PM., Search Strategy: We searched CINAHL, EMBASE, Medline, Global Health, and Pubmed from 2009 to 2016., Selection Criteria: Reports of stillbirth causes in unselective cohorts., Data Collection and Analysis: Pooled estimates of causes were derived for country representative reports. Systems and causes were assessed for alignment with the ICD-PM. Data are presented by income setting (low, middle, and high income countries; LIC, MIC, HIC)., Main Results: Eighty-five reports from 50 countries (489 089 stillbirths) were included. The most frequent categories were Unexplained, Antepartum haemorrhage, and Other (all settings); Infection and Hypoxic peripartum (LIC), and Placental (MIC, HIC). Overall report quality was low. Only one classification system fully aligned with ICD-PM. All stillbirth causes mapped to ICD-PM. In a subset from HIC, mapping obscured major causes., Conclusions: There is a paucity of quality information on causes of stillbirth globally. Improving investigation of stillbirths and standardisation of audit and classification is urgently needed and should be achievable in all well-resourced settings. Implementation of the WHO Perinatal Mortality Audit and Review guide is needed, particularly across high burden settings., Funding: HR, SH, SHL, and AW were supported by an NHMRC-CRE grant (APP1116640). VF was funded by an NHMRC-CDF (APP1123611)., Tweetable Abstract: Urgent need to improve data on causes of stillbirths across all settings to meet global targets., Plain Language Summary: Background and methods Nearly three million babies are stillborn every year. These deaths have deep and long-lasting effects on parents, healthcare providers, and the society. One of the major challenges to preventing stillbirths is the lack of information about why they happen. In this study, we collected reports on the causes of stillbirth from high-, middle-, and low-income countries to: (1) Understand the causes of stillbirth, and (2) Understand how to improve reporting of stillbirths. Findings We found 85 reports from 50 different countries. The information available from the reports was inconsistent and often of poor quality, so it was hard to get a clear picture about what are the causes of stillbirth across the world. Many different definitions of stillbirth were used. There was also wide variation in what investigations of the mother and baby were undertaken to identify the cause of stillbirth. Stillbirths in all income settings (low-, middle-, and high-income countries) were most frequently reported as Unexplained, Other, and Haemorrhage (bleeding). Unexplained and Other are not helpful in understanding why a baby was stillborn. In low-income countries, stillbirths were often attributed to Infection and Complications during labour and birth. In middle- and high-income countries, stillbirths were often reported as Placental complications. Limitations We may have missed some reports as searches were carried out in English only. The available reports were of poor quality. Implications Many countries, particularly those where the majority of stillbirths occur, do not report any information about these deaths. Where there are reports, the quality is often poor. It is important to improve the investigation and reporting of stillbirth using a standardised system so that policy makers and healthcare workers can develop effective stillbirth prevention programs. All stillbirths should be investigated and reported in line with the World Health Organization standards., (© 2017 Royal College of Obstetricians and Gynaecologists.)

Objective: To understand challenges in care after stillbirth and provide tailored solutions., Design: Multi-centre case study., Setting: Three maternity hospitals., Population: Parents with a stillborn baby, maternity staff., Methods: Thematic analysis of parent interviews and staff focus groups and service provision investigation., Outcomes: 1 Themes; 2 Triangulation matrix; 3 Recommendations., Results: Twenty-one women, 14 partners, and 22 staff participated. Service Provision: Care for parents after stillbirth varies excessively; there are misconceptions; post-mortem does not delay follow-up., Presentation: Women 'do not feel right' before stillbirth; their management is haphazard and should be standardised., Diagnosis: Stillbirth is an emergency for parents but not always for staff; communication can seem cold; well-designed bereavement space is critical. Birth: Staff shift priorities to mother and future, but for parents their baby is still a baby; parents are not comfortable with staff recommending vaginal birth as the norm; there are several reasons why parents ask for a caesarean; better care involves clear communication, normal behaviour, and discussion of coping strategies. Post-mortem: Parents are influenced by discussions with staff. Staff should 'sow seeds', clarify its respectful nature, delineate its purpose, and explain the timescale., Follow-Up: It is not standardised; parents wish to see their multi-professional team., Conclusions: There is unacceptable variation in care after stillbirth, and insensitive interactions between staff and bereaved parents. Understanding parents' needs, including why they ask for caesarean birth, will facilitate joint decision-making. Every bereaved parent is entitled to good, respectful care., Tweetable Abstract: Care too varied & interactions often insensitive after stillbirth; national pathway & training urgently needed PLAIN LANGUAGE SUMMARY: Why and how was the study carried out? Previous studies have shown that improving care after stillbirth is important for families. We investigated the opinions of bereaved parents and maternity staff to find ways to improve care. At three hospitals in 2013, all women who experienced a stillbirth were invited to an interview along with their partners. Thirty-five parents of 21 babies agreed to participate. Twenty-two obstetricians and midwives took part in focus group discussions. What were the main findings? Care was often not as good as it should and could be. Communication with parents was not always as sensitive as they would have liked because staff did not have appropriate training. Some women reported they did not 'feel right' before going to hospital. Once they arrived, there was no standard approach to how care was given. Sometimes there were long delays before the death of the baby was confirmed and action was taken. After it had been confirmed that the baby had died, staff focussed on the mothers' needs, but the parents' priorities were still with their baby. There were several reasons why parents asked for a caesarean birth that staff had not considered. Staff influenced parents' decisions about post-mortem examinations. Parents found it helpful when staff explained the respectful nature and purpose of the examination. After discharge from hospital, there was no consistent plan for how follow-up care would be given. Parents would have liked more information about their next hospital appointment. What are the limitations of the work? The parents interviewed depended on their memories of the details of the care, which happened some time ago. In staff group discussions, junior doctors may not have spoken openly because there were senior doctors present. Further research is necessary to understand and improve care globally. What is the implication for parents? Every bereaved parent is entitled to the best possible care after stillbirth, but some do not get good care. Parents and staff made suggestions that can help to develop processes for how care is given after stillbirth. These suggestions can also inform staff training, so that every single parent is treated respectfully and participates in decision making., (© 2017 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

Objective: To assess the frequency of additional care, and parents' perceptions of quality, respectful care, in pregnancies subsequent to stillbirth., Design: Multi-language web-based survey., Setting: International., Population: A total of 2716 parents, from 40 high- and middle-income countries., Methods: Data were obtained from a broader survey of parents' experiences following stillbirth. Data were analysed using descriptive statistics and stratified by geographic region. Subgroup analyses explored variation in additional care by gestational age at index stillbirth., Main Outcome Measures: Frequency of additional care, and perceptions of quality, respectful care., Results: The majority (66%) of parents conceived their subsequent pregnancy within 1 year of stillbirth. Additional antenatal care visits and ultrasound scans were provided for 67% and 70% of all parents, respectively, although there was wide variation across geographic regions. Care addressing psychosocial needs was less frequently provided, such as additional visits to a bereavement counsellor (10%) and access to named care provider's phone number (27%). Compared with parents whose stillbirth occurred at ≤ 29 weeks of gestation, parents whose stillbirth occurred at ≥ 30 weeks of gestation were more likely to receive various forms of additional care, particularly the option for early delivery after 37 weeks. Around half (47-63%) of all parents felt that elements of quality, respectful care were consistently applied, such as spending enough time with parents and involving parents in decision-making., Conclusions: Greater attention is required to providing thoughtful, empathic and collaborative care in all pregnancies following stillbirth. Specific education and training for health professionals is needed., Tweetable Abstract: More support for providing quality care in pregnancies after stillbirth is needed., Plain Language Summary: Study rationale and design More than two million babies are stillborn every year. Most parents will conceive again soon after having a stillborn baby. These parents are more likely to have another stillborn baby in the next pregnancy than parents who have not had a stillborn baby before. The next pregnancy after stillbirth is often an extremely anxious time for parents, as they worry about whether their baby will survive. In this study we asked 2716 parents from 40 countries about the care they received during their first pregnancy after stillbirth. Parents were recruited mainly through the International Stillbirth Alliance and completed on online survey that was available in six languages. Findings Parents often had extra antenatal visits and extra ultrasound scans in the next pregnancy, but they rarely had extra emotional support. Also, many parents felt their care providers did not always listen to them and spend enough time with them, involve them in decisions, and take their concerns seriously. Parents were more likely to receive various forms of extra care in the next pregnancy if their baby had died later in pregnancy compared to earlier in pregnancy. Limitations In this study we only have information from parents who were able and willing to complete an online survey. Most of the parents were involved in charity and support groups and most parents lived in developed countries. We do not know how well the findings relate to other parents. Finally, our study does not include parents who may have tried for another pregnancy but were not able to conceive. Potential impact This study can help to improve care through the development of best practice guidelines for pregnancies following stillbirth. The results suggest that parents need better emotional support in these pregnancies, and more opportunities to participate actively in decisions about care. Extra support should be available no matter how far along in pregnancy the previous stillborn baby died., (© 2016 Royal College of Obstetricians and Gynaecologists.)

Background: Following a perinatal death, a formal standardised multi-disciplinary review should take place, to learn from the death of a baby and facilitate improvements in future care. It has been recommended that bereaved parents should be offered the opportunity to give feedback on the care they have received and integrate this feedback into the perinatal mortality review process. However, the MBRRACE-UK Perinatal Confidential Enquiry (2015) found that only one in 20 cases parental concerns were included in the review. Although guidance suggests parental opinion should be sought, little evidence exists on how this may be incorporated into the perinatal mortality review process. The purpose of the PARENTS study was to investigate bereaved parents' views on involvement in the perinatal mortality review process., Methods: A semi-structured focus group of 11 bereaved parents was conducted in South West England. A purposive sampling technique was utilised to recruit a diverse sample of women and their partners who had experienced a perinatal death more than 6 months prior to the study. A six-stage thematic analysis was followed to explore parental perceptions and expectations of the perinatal mortality review process., Results: Four over-arching themes emerged from the analysis: transparency; flexibility combined with specificity; inclusivity; and a positive approach. It was evident that the majority of parents were supportive of their involvement in the perinatal mortality review process and they wanted to know the outcome of the meeting. It emerged that an individualised approach should be taken to allow flexibility on when and how they could contribute to the process. The emotional aspects of care should be considered as well as the clinical care. Parents identified that the whole care pathway should be examined during the review including antenatal, postnatal, and neonatal and community based care. They agreed that there should be an opportunity for parents to give feedback on both good and poor aspects of their care., Conclusion: Parents were unaware that a review of their baby's death took place in the hospital. Parental involvement in the perinatal mortality review process would promote an open culture in the healthcare system and learning from adverse events including deaths. Further research should focus on designing and evaluating a perinatal mortality review process where parental feedback will be integral.

Background: Many adverse pregnancy outcomes in the UK could be prevented with better intrapartum care. Training for intrapartum emergencies has been widely recommended but there are conflicting data about their effectiveness. Observational studies have shown sustained local improvements in perinatal outcomes associated with the use of the PRactical Obstetric Multi-Professional Training - (PROMPT) training package. However this effect needs to be investigated in the context of randomised study design in settings other than enthusiastic early adopter single-centres. The main aim of this study is to determine the effectiveness of PROMPT to reduce the rate of term infants born with low APGAR scores., Methods: THISTLE (Trial of Hands-on Interprofessional Simulation Training for Local Emergencies) is a multi-centre stepped-wedge clustered randomised controlled superiority trial conducted across 12 large Maternity Units in Scotland. On the basis of prior observational findings all Units have been offered the intervention and have been randomly allocated in groups of four Units, to one of three intervention time periods, each six months apart. Teams of four multi-professional clinicians from each participating Unit attended a two-day PROMPT Train the Trainers (T3) programme prior to the start of their allocated intervention step. Following the T3 training, the teams commenced the implementation of local intrapartum emergency training in their own Units by the start of their allocated intervention period. Blinding has not been possible due to the nature of the intervention. The aim of the study is to follow up each Unit for at least 12-months after they have commenced their local courses. The primary outcome for the study is the proportion of Apgar scores <7 at 5 min for term vaginal or emergency caesarean section births (≥37 weeks) occurring in each of the study Units. These data will be extracted from the Information Services Division Scottish Morbidity Record 02, a national routine data collection on pregnancy and births. Mixed or marginal logistic regression will be employed for the main analysis., Discussion: THISTLE is the first stepped wedge cluster randomised trial to evaluate the effectiveness of an intrapartum emergencies training programme. The results will inform training, trainers and policy going forward., Trial Registration: ISRCTN11640515 (registered on 09/09/2013).