Intramuscular oxytocin versus Syntometrine® versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double-blinded clinical trial of effectiveness, side effects and quality of life.

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.

Maternity services in the UK during the coronavirus disease 2019 pandemic: a national survey of modifications to standard care.

OBJECTIVE: To explore the modifications to maternity services across the UK, in response to the coronavirus disease 2019 (COVID-19) pandemic, in the context of the pandemic guidance issued by the Royal College of Obstetricians and Gynaecologists (RCOG), Royal College of Midwives (RCM) and NHS England. DESIGN: National survey. SETTING: UK maternity services during the COVID-19 pandemic. POPULATION OR SAMPLE: Healthcare professionals working within maternity services. METHODS: A national electronic survey was developed to investigate local modifications to general and specialist maternity care during the COVID-19 pandemic, in the context of the contemporaneous national pandemic guidance. After a pilot phase, the survey was distributed through professional networks by the RCOG and co-authors. The survey results were presented descriptively in tabular and graphic formats, with proportions compared using chi-square tests. MAIN OUTCOME MEASURES: Service modifications made during the pandemic. RESULTS: A total of 81 respondent sites, 42% of the 194 obstetric units in the UK, were included. They reported substantial and heterogeneous maternity service modifications. Seventy percent of units reported a reduction in antenatal appointments and 56% reported a reduction in postnatal appointments; 89% reported using remote consultation methods. A change to screening pathways for gestational diabetes mellitus was reported by 70%, and 59% had temporarily removed the offer of births at home or in a midwife-led unit. A reduction in emergency antenatal presentations was experienced by 86% of units. CONCLUSIONS: This national survey documents the extensive impact of the COVID-19 pandemic on maternity services in the UK. More research is needed to understand the impact on maternity outcomes and experience. TWEETABLE ABSTRACT: A national survey showed that UK maternity services were modified extensively and heterogeneously in response to COVID-19.

The role of operative vaginal birth in the 21st century and a way forward.

Effective devices and effective, validated training can improve operative vaginal birth outcomes for women and their babies. TWEETABLE ABSTRACT: Effective devices and effective, validated training can improve operative vaginal birth outcomes for women and their babies.

Fetal head position and perineal distension associated with the use of the BD Odon Device™ in operative vaginal birth: a simulation study.

OBJECTIVE: To investigate (1) the placement of the BD Odon Device on the model fetal head and (2) perineal distention during simulated operative vaginal births conducted with the BD Odon Device. DESIGN: Observational simulation study. SETTING: North Bristol NHS Trust, UK. POPULATION OR SAMPLE: Four hundred and forty simulated operative vaginal births. METHODS: Three bespoke fetal mannequins were developed to represent (1) bi-parietal diameter of the 50th centile at term, (2) bi-parietal diameter at the 5th centile at term, and (3) 50th centile head with 2 cm of caput. Siting of the BD Odon Device on model heads was determined before and after 400 simulated operative vaginal births. Variables were analysed to determine their effect on device siting and movement during birth. The fetal mannequins were placed inside a maternal mannequin and the BD Odon Device was placed around the fetal head as per the instructions for use. The location of the air cuff was determined before and after the head was delivered. Perineal distension was determined by recording maximum perineal distention during a simulated operative vaginal birth using the same procedure, as well as scenarios employing an inappropriately non-deflated air cuff (for the BD Odon Device), the Kiwi ventouse and non-rotational forceps. MAIN OUTCOME MEASURES: Site and displacement during birth of the BD Odon Device on a model head. Maximal perineal distension during birth. RESULTS: The BD Odon Device was reliably sited in a standard over the fetal head position (approximately 40 mm above the fetal chin) for all stations, head sizes and positions with no significant displacement. In occipito-posterior births, compared with occipito-anterior or transverse, the BD Odon Device routinely sited further down the fetal head (toward the chin). The BD Odon Device was not associated with more perineal distension compared with forceps or Kiwi ventouse (respectively 21, 26 and 21 mm at posterior fourchette). CONCLUSIONS: The BD Odon Device reliably sited over a safe area of the fetal head in 400 simulated births representative of clinical practice. The BD Odon Device generates similar levels of perineal distension compared with Kiwi ventouse when used correctly. TWEETABLE ABSTRACT: Location of the BD Odon Device on a fetal head in simulation.

Design and development of the BD Odon DeviceTM : a human factors evaluation process.

OBJECTIVE: To (1) determine how intended users interact with and use the BD Odon Device in simulation, (2) use these findings to alter progressively the design of the BD Odon Device and (3) validate that these changes have improved the ability of practitioners to use the BD Odon Device. DESIGN: Human factors evaluation study. SETTING: Simulation suite designed to mimic delivery room. POPULATION OR SAMPLE: Three hundred and ninety simulated operative births, performed by 100 practising clinicians. METHODS: Simulated operative vaginal births performed using the BD Odon Device and the device Instructions for use were subjected to three formative human factors evaluations and one human factors validation test. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions for use were modified. MAIN OUTCOME MEASURES: Successful performance of an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions for use. RESULTS: Using version two of the BD Odon Device, and following exposure to face-to-face training and written instructions, 25% of accouchers were able successfully to perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able successfully to perform a simulated operative vaginal birth using version four of the BD Odon Device. CONCLUSIONS: Human factors evaluations have enabled a multi-professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for use in an evidence-based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use. TWEETABLE ABSTRACT: Human Factors evaluations help make the BD Odon Device safe and usable for clinical practice.

Pressure and traction on a model fetal head and neck associated with the use of forceps, Kiwi™ ventouse and the BD Odon Device™ in operative vaginal birth: a simulation study.

OBJECTIVE: To determine the pressure and traction forces exerted on a model fetal head by the BD Odon Device, forceps and Kiwi ventouse during simulated births. DESIGN: Simulation study. SETTING: Simulated operative vaginal birth. POPULATION OR SAMPLE: Eighty-four simulated operative vaginal births. METHODS: A bespoke fetal mannequin with pressure sensors around the head and strain gauge across the neck was used to investigate pressure applied over the head, and traction across the neck during 84 simulated births using the BD Odon Device, non-rotational forceps and Kiwi ventouse. MAIN OUTCOME MEASURES: Peak pressure on the fetal face and lateral aspects of the head during correct use of the BD Odon Device and forceps. Peak pressure on orbits and neck during misplacement of the BD Odon Device and forceps. Peak traction force generated until instrument failure using the BD Odon Device, forceps and Kiwi ventouse. RESULTS: When correctly sited and using 80 kPa inflation pressure on the cuff, the BD Odon Device generated a lower peak pressure on the fetal head than forceps (83 versus 146 kPa). When instruments were purposefully misplaced over the orbits, the BD Odon Device generated a lower peak pressure on the orbits compared with forceps (70 versus 123 kPa). When purposefully misplaced over the neck, the BD Odon Device, compared with forceps, generated a greater peak pressure on the anterio-lateral aspect of the neck (56 versus 17 kPa) and a lower peak pressure on the posterior aspect of the neck (76 versus 93 kPa) than forceps. In cases of true cephalic disproportion, the BD Odon Device 'popped-off' at a lower traction force than did forceps (208 versus 270 N). CONCLUSIONS: In simulated assisted vaginal birth with correctly placed instruments, the peak pressure exerted on the fetal head by a BD Odon Device is lower than the pressure exerted by non-rotational forceps. In cases in which delivery of the fetal head is not possible due to cephalo-pelvic disproportion, lower traction forces could be applied using the BD Odon Device than with forceps before the procedure was abandoned due to device failure. TWEETABLE ABSTRACT: BD Odon Device exerts less pressure on a model fetal head than forceps, but more than Kiwi ventouse.

Reduction in resource use with the misoprostol vaginal insert vs the dinoprostone vaginal insert for labour induction: a model-based analysis from a United Kingdom healthcare perspective.

BACKGROUND: In view of the increasing pressure on the UK's maternity units, new methods of labour induction are required to alleviate the burden on the National Health Service, while maintaining the quality of care for women during delivery. A model was developed to evaluate the resource use associated with misoprostol vaginal inserts (MVIs) and dinoprostone vaginal inserts (DVIs) for the induction of labour at term. METHODS: The one-year Markov model estimated clinical outcomes in a hypothetical cohort of 1397 pregnant women (parous and nulliparous) induced with either MVI or DVI at Southmead Hospital, Bristol, UK. Efficacy and safety data were based on published and unpublished results from a phase III, double-blind, multicentre, randomised controlled trial. Resource use was modelled using data from labour induction during antenatal admission to patient discharge from Southmead Hospital. The model's sensitivity to key parameters was explored in deterministic multi-way and scenario-based analyses. RESULTS: Over one year, the model results indicated MVI use could lead to a reduction of 10,201 h (28.9%) in the time to vaginal delivery, and an increase of 121% and 52% in the proportion of women achieving vaginal delivery at 12 and 24 h, respectively, compared with DVI use. Inducing women with the MVI could lead to a 25.2% reduction in the number of midwife shifts spent managing labour induction and 451 fewer hospital bed days. These resource utilisation reductions may equate to a potential 27.4% increase in birthing capacity at Southmead Hospital, when using the MVI instead of the DVI. CONCLUSIONS: Resource use, in addition to clinical considerations, should be considered when making decisions about labour induction methods. Our model analysis suggests the MVI is an effective method for labour induction, and could lead to a considerable reduction in resource use compared with the DVI, thereby alleviating the increasing burden of labour induction in UK hospitals.

Prevention of brachial plexus injury-12 years of shoulder dystocia training: an interrupted time-series study.

OBJECTIVE: To investigate management and outcomes of incidences of shoulder dystocia in the 12 years following the introduction of an obstetric emergencies training programme. DESIGN: Interrupted time-series study comparing management and neonatal outcome of births complicated by shoulder dystocia over three 4-year periods: (i) Pre-training (1996-99), (ii) Early training (2001-04), and (iii) Late training (2009-12). SETTING: Southmead Hospital, Bristol, UK, with approximately 6000 births per annum. POPULATION: Infants and their mothers who experienced shoulder dystocia. METHOD: A bi-monthly multi-professional 1-day intrapartum emergencies training course, that included a 30-minute practical session on shoulder dystocia management, commenced in 2000. MAIN OUTCOMES: Neonatal morbidity (brachial plexus injury, humeral fracture, clavicular fracture, 5-minute Apgar score <7) and documented management of shoulder dystocia (resolution manoeuvres performed, traction applied, head-to-body delivery interval). RESULTS: Compliance with national guidance improved with continued training. At least one recognised resolution manoeuvre was used in 99.8% (561/562) of cases of shoulder dystocia in the late training period, demonstrating a continued improvement from 46.3% (150/324, P < 0.001) pre-training, and 92% (241/262, P < 0.001) in the early training period. In parallel there was reduction in the brachial plexus injury at birth (24/324 [7.4%, P < 0.01], pre-training, 6/262 [2.3%] early training, and 7/562 [1.3%] late training. CONCLUSIONS: There are significant benefits to long-term, embedded training programmes with improvements in both management and outcomes. A decade after the introduction of training there were no cases of brachial plexus injury lasting over 12 months in 562 cases of shoulder dystocia.

Effective interprofessional simulation training for medical and midwifery students.

Introduction: Good interprofessional teamworking is essential for high quality, efficient and safe clinical care. Undergraduate interprofessional training has been advocated for many years to improve interprofessional working. However, few successful initiatives have been reported and even fewer have formally assessed their educational impact. Methods: This was a prospective observational study of medical and midwifery students at a tertiary-level maternity unit. An interprofessional training module was developed and delivered by a multiprofessional faculty to medical and midwifery students, including short lectures, team-building exercises and practical simulation-based training for one obstetric (shoulder dystocia) and three generic emergencies (sepsis, haemorrhage, collapse). Outcome measures were interprofessional attitudes, assessed with a validated questionnaire (UWE Interprofessional Questionnaire) and clinical knowledge, measured with validated multiple-choice questions. Results: Seventy-two students participated (34 medical, 38 midwifery). Following training median interprofessional attitude scores improved in all domains (p<0.0001), and more students responded in positive categories for communication and teamwork (69-89%, p=0.004), interprofessional interaction (3-16%, p=0.012) and interprofessional relationships (74-89%, p=0.006). Scores for knowledge improved following training for medical students (65.5% (61.8-70%) to 82.3% (79.1-84.5%) (median (IQR)) p<0.0001) and student midwives (70% (64.1-76.4%) to 81.8% (79.1-86.4%) p<0.0001), and in all subject areas (p<0.0001). Conclusions: This training was associated with meaningful improvements in students' attitudes to teamwork, and knowledge acquisition. Integrating practical tasks and teamwork training, in authentic clinical settings, with matched numbers of medical and non-medical students can facilitate learning of both why and how to work together. This type of training could be adopted widely in undergraduate healthcare education.

Adaptation and implementation of local maternity dashboards in a Zimbabwean hospital to drive clinical improvement.

PROBLEM: The Commission on Information and Accountability for Women's and Children's Health of the World Health Organization (WHO) reported that national health outcome data were often of questionable quality and "not timely enough for practical use by health planners and administrators". Delayed reporting of poor-quality data limits the ability of front-line staff to identify problems rapidly and make improvements. APPROACH: Clinical "dashboards" based on locally available data offer a way of providing accurate and timely information. A dashboard is a simple computerized tool that presents a health facility's clinical data graphically using a traffic-light coding system to alert front-line staff about changes in the frequency of clinical outcomes. It provides rapid feedback on local outcomes in an accessible form and enables problems to be detected early. Until now, dashboards have been used only in high-resource settings. LOCAL SETTING: An overview maternity dashboard and a maternal mortality dashboard were designed for, and introduced at, a public hospital in Zimbabwe. A midwife at the hospital was trained to collect and input data monthly. RELEVANT CHANGES: Implementation of the maternity dashboards was feasible and 28 months of clinical outcome data were summarized using common computer software. Presentation of these data to staff led to the rapid identification of adverse trends in outcomes and to suggestions for actions to improve health-care quality. LESSONS LEARNT: Implementation of maternity dashboards was feasible in a low-resource setting and resulted in actions that improved health-care quality locally. Active participation of hospital management and midwifery staff was crucial to their success.