Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study.

Background: The first feasibility study of the OdonAssist inflatable device for use in clinically indicated assisted vaginal birth reported a success rate of 48% with no significant safety concerns. Additional studies exploring the device performance in other clinical settings are warranted before definitive conclusions can be drawn about its safety and efficacy in current practice.

Objective: This study aimed to investigate the safety and efficacy of the OdonAssist before conducting a randomized controlled trial.

The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom).

Background: Decreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability.

Assisted vaginal birth in 21st century: current practice and new innovations.

Assisted vaginal birth rates are falling globally with rising cesarean delivery rates. Cesarean delivery is not without consequence, particularly when carried out in the second stage of labor. Cesarean delivery in the second stage is not entirely protective against pelvic floor morbidity and can lead to serious complications in a subsequent pregnancy.

Women's and midwives' views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study.

Background: Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss and answer questions whilst maintaining equipoise.

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England.

Objective: When novel devices are used 'in human' for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.

Design: We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device.

Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England.

Objective: To investigate women's experiences of having a birth assisted by the Odon Device (an innovative device for assisted vaginal birth) and participation in intrapartum research.

Design: Qualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study.

Setting: A tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019.

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.

Objective: Assisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs.

Impacted fetal head: A retrospective cohort study of emergency caesarean section.

Objective: To investigate risk factors, management and outcomes of impacted fetal head (IFH) at caesarean section (CS).

Study Design: This is a retrospective cohort study of all women with singleton, cephalic pregnancies who had an emergency CS during one-year (2016) at North Bristol NHS Trust, UK (n = 838). The incidence of caesarean section at full dilatation (CSFD) and IFH were calculated using the annual birth rate.

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy-The ASSIST II study.

Background: The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented.

Assisted vaginal birth with the Odon Device.

The Odon Device is an innovative investigational device for assisted vaginal birth (AVB) and has not yet been granted regulatory approval for sale in any country. It is the first innovation in AVB since the introduction of the vacuum extractor in the 1950's and the device is designed for use by different level of trained health care providers. Efficacy studies are presently in progress in two centers: The ASSIST II Study, Bristol, England, and The BESANCON ASSIST Study, Besançon, France.

Outcomes of the novel Odon Device in indicated operative vaginal birth.

Background: No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications.

Simulation for intrapartum care: from training to novel device innovation.

Improving maternal and perinatal care is a global priority. Simulation training and novel applications of simulation for intrapartum care may help to reduce preventable deaths worldwide. Evaluation studies have published details of the effectiveness of simulation training for obstetric emergencies, exploring clinical and non-clinical factors as well as the impact on patient outcomes (both maternal and neonatal).

Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

Introduction: Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs).

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study.

Background: Assisted vaginal birth is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for assisted vaginal birth (forceps and ventouse) are often not utilised in settings where there is most clinical need, resulting in maternal and neonatal morbidity and mortality which could have been prevented. The BD Odon Device is a new device for assisted vaginal birth that may be able to address this unmet need.

Skills training for operative vaginal birth.

Skilled, safe operative vaginal birth can substantially improve maternal and neonatal outcomes arising from complications in the second stage of labour and should be available in a diverse range of maternity settings for women across the world. Operative vaginal births are complex, requiring a combination of good technical skills, non-technical skills as well as sensitivity from the accoucher. It is axiomatic that accouchers should be adequately trained and simulation-based training is a promising strategy to improve outcomes and increase the rates of operative vaginal birth.

Improving incident reporting among junior doctors.

To ensure systems in hospitals improve to make patient care safer, learning must occur when things go wrong. Incident reporting is one of the commonest mechanisms used to learn from harm events and near misses. Only a relatively small number of incidents that occur are actually reported and different groups of staff have different rates of reporting.