Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study).

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).

Management of obstetric postpartum hemorrhage: a national service evaluation of current practice in the UK.

BACKGROUND: Postpartum hemorrhage (PPH) continues to be one of the major causes of maternal mortality and morbidity in obstetrics. Variations in practice often lead to adverse maternity outcomes following PPH. Our objective was to assess the current practice in managing PPH in the UK. METHODS: We performed a national multicenter prospective service evaluation study over one calendar month and compared the current performance to national standards for managing PPH. We used a standardized data collection tool and collected data on patients' demographics, incidence of PPH, estimated blood loss (EBL), prophylactic and treatment measures, onset of labor, and mode of delivery. RESULTS: We collected data from 98 obstetric units, including 3663 cases of primary PPH. Fifty percent of cases were minor PPH (EBL 500-1000 mL, n=1900/3613, 52.6%) and the remaining were moderate PPH (EBL >1000 to <2000 mL, n=1424/3613, 39.4%) and severe PPH (EBL >2000 mL, n=289/3613, 8%). The majority of women received active management of the third stage of labor (3504/3613, 97%) most commonly with Syntometrine intramuscular (1479/3613, 40.9%). More than half required one additional uterotonic agent (2364/3613, 65.4%) most commonly with Syntocinon intravenous infusion (1155/2364, 48.8%). There was a poor involvement of consultant obstetricians and anesthetists in managing PPH cases, which was more prevalent when managing major PPH (p=0.0001). CONCLUSION: There are still variations in managing PPH in the UK against national guidelines. More senior doctor involvement and regular service evaluation are needed to improve maternal outcomes following PPH.

Could low Safety Attitudes Questionnaire scores be indicative of an environment where it may be difficult to get new training practices established?

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.

Carbetocin versus oxytocin for prevention of post-partum haemorrhage at caesarean section in the United Kingdom: An economic impact analysis.

OBJECTIVE: To determine the economic impact of the introduction of carbetocin for the prevention of postpartum haemorrhage (PPH) at caesarean section, compared to oxytocin. STUDY DESIGN: The model is a decision tree conducted from a UK National Health Service perspective. 1500 caesarean sections (both elective and emergency) were modelled over a 12 month period. Efficacy data was taken from a published Cochrane meta-analysis, and costs from NHS Reference costs, the British National Formulary and the NHS electronic Medicines Information Tool. A combination of hospital audit data and expert input from an advisory board of clinicians was used to inform resource use estimates. The main outcome measures were the incidence of PPH and total cost over a one year time horizon, as a result of using carbetocin compared to oxytocin for prevention of PPH at caesarean section. RESULTS: The use of carbetocin compared to oxytocin for prevention of PPH at caesarean section was associated with a reduction of 30 (88 vs 58) PPH events (>500ml blood loss), and a cost saving of £27,518. In probabilistic sensitivity analysis, carbetocin had a 91.5% probability of producing better outcomes, and a 69.4% chance of being dominant (both cheaper and more effective) compared to oxytocin. CONCLUSION: At list price, the introduction of carbetocin appears to provide improved clinical outcomes along with cost savings, though this is subject to uncertainty regarding the underlying data in efficacy, resource use, and cost.

Identifying Deteriorating Patients Through Multidisciplinary Team Training.

Multidisciplinary training has improved maternity outcomes when the training has been well attended, regular, in house, used high-fidelity simulators, and integrated teamwork training. If these principles were used in other settings, better clinical care may result. This before-after study sought to establish whether a short multidisciplinary training intervention can improve recognition of the deteriorating patient using an aggregated physiological parameter scoring system (Early Warning Score [EWS]). Nursing, medical, and allied nursing staff participated in an hour-long training session, using real-life scenarios with simple tools and structured debriefing. After training, staff were more likely to calculate EWS scores correctly (68.02% vs 55.12%; risk ratio [RR] = 1.24, 95% confidence interval [CI] = 1.07-1.44), and observations were more likely to be performed at the correct frequency (78.57% vs 68.09%; RR = 1.20, 95% CI = 1.09-1.32). Multidisciplinary training, according to core principles, can lead to more accurate identification of deteriorating patients, with implications for subsequent care and outcome.

Multiprofessional team simulation training, based on an obstetric model, can improve teamwork in other areas of health care.

This interrupted time-series study evaluated the impact of multiprofessional scenario-based training on the safety culture and teamwork climate of 3 surgical wards during a time of reduced financial resources. The authors ran 22 team training sessions for teams of 4 to 5 medical and nursing staff over a 4-month period on 3 surgical wards, using 2 scenarios based on a previously successful obstetric training program. Safety culture was measured before and after training using a validated psychometric questionnaire. After training there was a statistically significant improvement in safety culture (P = .036) on the wards. Teamwork climate improved, but the evidence was not as strong (P = .052). Perceptions of hospital management and adequacy of staffing levels showed significant deterioration. Simple, low-resource interventions can have a significant positive impact on safety culture and possibly teamwork climate on surgical wards. This could be of great value in maintaining patient safety at times of financial constraint.