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Objectives: To explore the association between abnormal uterine artery Dopplers (combined PI > 2.5) - with normal PAPP-A - and adverse obstetric/neonatal outcomes., Methods: This was a retrospective cohort study of 800 patients between 1 March 2019 - 23 November 2021 in a tertiary UK hospital, where it is routine to measure uterine artery Dopplers of all pregnancies during their anomaly scans. 400 nulliparous women/birthing people with complete data were included. 400 nulliparous controls scanned in the same time frame (1.5 years) with normal PAPP-A and uterine artery Dopplers were matched for age and BMI. Outcomes included: mode of birth, postpartum complications, birth weight/centile, Apgar score, gestational age at delivery, neonatal unit admission, and clinical neonatal hypoglycemia. Multivariable analysis was used., Results: Compared to controls, pregnancies with abnormal uterine artery Dopplers and normal PAPP-A were at increased risk of induction (46.5% vs 35.5%, p  = .042), cesarean section (46.0% vs 38.0%, p  = .002), emergency cesarean section (35.0% vs 26.5%, p  = .009), and pre-eclampsia 5.8% vs 2.5%, p  = .021). Their babies were more likely to be admitted to the neonatal unit - mostly for prematurity (15.3% vs 6.3%, p  = .0004), hypoglycemia (4.0% vs 1.0%, p  = .007), be small for gestational age (26.5% vs 11.5%, p  = .0001), had intrauterine growth restriction (10.8% vs 1.3%, p  = .0001), and be born prematurely (10.0% vs 3.5%, p  = .002). Routine measurement of uterine artery Dopplers increased the detection rate of small for gestational age fetuses by 15.1%. Over half of the babies admitted with neonatal hypoglycemia in pregnancies with abnormal uterine artery Dopplers had an unexplained cause., Conclusions: Pregnancies with abnormal uterine Dopplers are not only at increased risk of pre-eclampsia and small for gestational age fetuses/intrauterine growth restriction, but are also at increased risk of emergency cesarean section and adverse neonatal outcomes. The increased incidence of neonatal hypoglycemia is likely driven to some degree by prematurity and placental complications, but possibly also by undiagnosed glucose dysmetabolism. This may warrant routine measurement of uterine artery Dopplers in all pregnancies (regardless of risk), where feasible, to aid antenatal management and counseling.

Purpose: Women with a previous fetal demise have a 2-20 fold increased risk of another stillbirth in a subsequent pregnancy when compared to those who have had a live birth. Despite this, there is limited research regarding the management and outcomes of subsequent pregnancies. This study was conducted to accurately quantify the chances of a woman having a healthy subsequent pregnancy after a pregnancy loss., Methods: A retrospective study was conducted at a tertiary-level unit between March 2019 and April 2021. We collected data on all women with a history of previous fetal demise attending a specialized perinatal history clinic and compared the risk of subsequent stillbirth to those with a normal pregnancy outcome. Outcome data included birth outcome, obstetric and medical complications, gestational age and birth weight and mode of delivery. Those who had healthy subsequent pregnancies were compared with those who experienced adverse outcomes., Results: A total of 101 cases were reviewed. Ninety-six women with subsequent pregnancies after a history of fetal demise from 16 weeks were included. Seventy-nine percent of women ( n  = 76) delivered a baby at term, without complications. Overall, 2.1% had repeat pregnancy losses ( n  = 2) and 2.1% delivered babies with fetal growth restriction ( n  = 2). There were no cases of abruption in a subsequent pregnancy. Eighteen neonates were delivered prematurely (18.4%), 15 of these (83.3%) were due to iatrogenic causes and three (16.7%) were spontaneous. In univariable logistic regression analyses, those with adverse outcomes in subsequent pregnancies had greater odds of pre-eclampsia (Odds ratio *(OR) = 3.89, 95% CI = 1.05-14.43, p  = .042) and fetal growth restriction (OR = 4.58, 95% CI = 1.41-14.82, p  = 0.011) in previous pregnancies compared to those with healthy outcomes. However, in multivariable logistic regression analyses, neither variable had a significant odds ratio (OR = 2.03, 95% CI = 0.44-9.39, p  = .366 and OR = 3.42, 95% CI = 0.90 - 13.09, p  = .072 for pre-eclampsia and FGR, respectively)., Conclusion: Four in five women had a healthy subsequent pregnancy. This is a reassuring figure for women when contemplating another pregnancy, particularly if cared for in a specialist clinic.

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: 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).)

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.

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.)

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?'

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).

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.)

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: 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: 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: 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).

Background: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered., Methods/design: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial., Discussion: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed., Trial Registration: ISRCTN49328913 . Registered on 20 October 2015.

Background: With no evidence to guide management of the gastric band in pregnancy, we aim to compare outcomes according to band management., Methods: Data were collected on all women pregnant (November 2011-October 2012) following gastric banding, using the UK Obstetric Surveillance System surveillance system. We compared outcomes between band management groups and with national data., Results: Band management was variable; deflation 43.4%, inflation maintained 56.6%. The deflation group had lower risk of small for gestational age infants (no cases vs. 11.3%; risk ratio = 0.14, p  = 0.05). There was greater gestational weight gain (deflation 15.4 kg, inflation 7.6 kg; adjusted p  = 0.05), and perhaps higher risk of gestational hypertension (deflation 10.5%, inflation no cases; p  = 0.08) in the deflation group. Other maternal outcomes were similar between management groups but overall worse than national data., Conclusions: Deflation is associated with better outcomes for babies but worse outcomes for mothers than maintained inflation.

Introduction: Simulation-based, multiprofessional team training (SBMPTT) is used widely in healthcare, with evidence that it can improve clinical outcomes and be associated with a positive safety culture. Our aim was to explore the impact of introducing this type of training to a gynaecological team., Methods: In this interrupted time-series study, 'Safety Attitudes Questionnaire' (SAQ) data was collected both before and after SBMPTT was introduced to a gynaecological team., Results: Low baseline SAQ scores coincided with difficulty in establishing the training, meaning that at the end of our study period only a small proportion of staff had actually attended a training session. Despite trends towards improvement in scores for safety climate, teamwork climate and job satisfaction, no statistically significant difference was observed. There was however an improved perception of the level of collaboration between nursing staff and doctors after the introduction of training., Conclusions and Discussion: In this paper we explore a hypothesis that low baseline SAQ scores may highlight that the multiprofessional teams most in need of training work in environments where it is more challenging to implement. There is evidence from other specialties that multiprofessional team training works, now we need to understand how to address the barriers to getting it started. In this paper we suggest how the SAQ could be used as a directive tool for improvement; using the detailed analysis of the local safety culture it provides to both inform future training design and also provide management with an objective marker of progress., Competing Interests: Competing interests: DS is a member of the PROMPT Maternity Foundation. He has no financial interest from this association., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Introduction: Performing a pelvic examination is a core skill for all medical undergraduates. The use of hybrid simulation, manikin with patient actress, to attain technical and communication skills competencies and to improve the quality of care we offer women, has not been compared to other teaching methods before. Outcome measures were technical skills, communication skills and confidence in completing a pelvic examination., Methods: A cluster randomised control trial was conducted over an academic year. Forty-eight medical students who completed an 8-week obstetrics and gynaecology attachment were recruited. Clusters were randomly assigned for initial training on hybrid or manikin only models and attended an end of attachment Objective Structured Clinical Assessment., Results: Outcome data were received for 43/48 students (89.5%). Following the objectively structured clinical examination, the hybrid trained cohort had higher technical scores (mean 23 (95% CI 20.1 to 25.8) vs 16.7 (CI 14.7 to 18.6); mean difference 6.3, CI 3.0 to 9.6) and communication skills scores (mean 22.6 (CI 21.2 to 23.8) vs 15.9 (CI 14.4 to 17.3); mean difference 6.7, CI 4.8 to 8.5) compared to the manikin only trained participants. Confidence in undertaking future pelvic examinations were similar in the control and intervention groups; (p=0.10, r=0.18)., Conclusions: This study demonstrates the value of hybrid simulation compared to manikins alone in improving the short-term acquisition of competence in simulated pelvic examinations at an undergraduate level. Future research should focus on whether hybrid models lead to long-term acquisition of skill and comparison of these models with other innovative methods such as clinical teaching associates., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: 2.7 million babies were stillborn in 2015 worldwide; behind these statistics lie the experiences of bereaved parents. The first Lancet series on stillbirth in 2011 described stillbirth as one of the "most shamefully neglected" areas of public health, recommended improving interaction between families and frontline caregivers and made a plea for increased investment in relevant research., Methods: A systematic review of qualitative, quantitative and mixed-method studies researching parents and healthcare professionals experiences of care after stillbirth in high-income westernised countries (Europe, North America, Australia and South Africa) was conducted. The review was designed to inform research, training and improve care for parents who experience stillbirth., Results: Four thousand four hundred eighty eight abstracts were identified; 52 studies were eligible for inclusion. Synthesis and quantitative aggregation (meta-summary) was used to extract findings and calculate frequency effect sizes (FES%) for each theme (shown in italics), a measure of the prevalence of that finding in the included studies. Researchers' areas of interest may influence reporting of findings in the literature and result in higher FES sizes, such as; support memory making (53%) and fathers have different needs (18%). Other parental findings were more unexpected; Parents want increased public awareness (20%) and for stillbirth care to be prioritised (5%). Parental findings highlighted lessons for staff; prepare parents for vaginal birth (23%), discuss concerns (13%), give options & time (20%), privacy not abandonment (30%), tailored post-mortem discussions (20%) and post-natal information (30%). Parental and staff findings were often related; behaviours and actions of staff have a memorable impact on parents (53%) whilst staff described emotional, knowledge and system-based barriers to providing effective care (100%). Parents reported distress being caused by midwives hiding behind 'doing' and ritualising guidelines whilst staff described distancing themselves from parents and focusing on tasks as coping strategies. Parents and staff both identified the need for improved training (parents 25% & staff 57%); continuity of care (parents 15% & staff 36%); supportive systems & structures (parents 50%); and clear care pathways (parents 5%)., Conclusions: Parents' and healthcare workers' experiences of stillbirth can inform training, improve the provision of care and highlight areas for future research.

Background: Despite improvements in maternity healthcare services over the last few decades, more than 2.7 million babies worldwide are stillborn each year. The global health agenda is silent about stillbirth, perhaps, in part, because its wider impact has not been systematically analysed or understood before now across the world. Our study aimed to systematically review, evaluate and summarise the current evidence regarding the psychosocial impact of stillbirth to parents and their families, with the aim of improving guidance in bereavement care worldwide., Methods: Systematic review and meta-summary (quantitative aggregation of qualitative findings) of quantitative, qualitative, and mixed-methods studies. All languages and countries were included., Results: Two thousand, six hundred and nineteen abstracts were identified; 144 studies were included. Frequency effect sizes (FES %) were calculated for each theme, as a measure of their prevalence in the literature. Themes ranged from negative psychological symptoms post bereavement (77 · 1) and in subsequent pregnancies (27 · 1), to disenfranchised grief (31 · 2), and incongruent grief (28 · 5), There was also impact on siblings (23 · 6) and on the wider family (2 · 8). They included mixed-feelings about decisions made when the baby died (12 · 5), avoidance of memories (13 · 2), anxiety over other children (7 · 6), chronic pain and fatigue (6 · 9), and a different approach to the use of healthcare services (6 · 9). Some themes were particularly prominent in studies of fathers; grief suppression (avoidance)(18 · 1), employment difficulties, financial debt (5 · 6), and increased substance use (4 · 2). Others found in studies specific to mothers included altered body image (3 · 5) and impact on quality of life (2 · 1). Counter-intuitively, Some themes had mixed connotations. These included parental pride in the baby (5 · 6), motivation for engagement in healthcare improvement (4 · 2) and changed approaches to life and death, self-esteem, and own identity (25 · 7). In studies from low/middle income countries, stigmatisation (13 · 2) and pressure to prioritise or delay conception (9) were especially prevalent., Conclusion: Experiencing the birth of a stillborn child is a life-changing event. The focus of the consequences may vary with parent gender and country. Stillbirth can have devastating psychological, physical and social costs, with ongoing effects on interpersonal relationships and subsequently born children. However, parents who experience the tragedy of stillbirth can develop resilience and new life-skills and capacities. Future research should focus on developing interventions that may reduce the psychosocial cost of stillbirth.

Background: In line with the rise in the prevalence of obesity, an increasing number of women of childbearing age are undergoing laparoscopic adjustable gastric banding (LAGB), resulting in an increasing number of pregnancies with a band in place. Currently, there is no consensus on optimal band management in pregnancy. Some clinicians advocate leaving the band balloon inflated to reduce gestational weight gain and associated adverse perinatal outcomes. However, there are concerns that maintaining balloon inflation during pregnancy might increase the risk of band complications and adversely affect fetal development and/or growth as a result of reduced nutritional intake., Objectives: To compare maternal and perinatal outcomes for elective gastric band balloon deflation versus intention to maintain balloon inflation during pregnancy., Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2012) and the Web of Science database (1940 to September 2012)., Selection Criteria: Randomised-controlled trials comparing elective deflation of the gastric band balloon with intention to maintain balloon inflation in pregnant women who have undergone LAGB., Data Collection and Analysis: Two review authors independently assessed studies for inclusion., Main Results: No studies met the criteria for inclusion in the review., Authors' Conclusions: To date no randomised controlled trials exist that compare elective deflation of the gastric band balloon in pregnancy versus intention to maintain balloon inflation. Further research is needed to define the optimum management of the gastric band balloon in pregnancy.