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ObjectivesSuboptimal intrapartum electronic fetal heart rate monitoring using cardiotocography has remained a persistent problem (EFM-CTG). We aimed to identify the range of influences on the safety of using EFM-CTG in practice.DesignScoping review to identify influences related to the practice of intrapartum EFM.Data sourcesMEDLINE, Embase, CINAHL, Web of Science, Scopus, British Nursing Index, Cochrane Library, from 1 January 2001 to 25 August 2024, and grey literature.Eligibility criteriaArticles that reported potential influences on the clinical practice of intrapartum EFM-CTG in hospital-based intrapartum maternity care settings, including primary studies, secondary analyses, reviews, reports, conference abstracts and investigations relevant to maternity and obstetrics, in English. Evaluations of technological modifications to traditional EFM-CTG monitoring and analysis were excluded.Data extraction and synthesisWe extracted influences on EFM-CTG from the included studies. Findings were synthesised using a best-fit framework approach, structured using an existing 19-domain framework of contributory factors for patient safety incidents in hospitals.Results142 articles and 14 reports were included. Our synthesis identified influences on EFM practice across all 19 domains of the contributory factors framework, including those relating to cognitive, social and organisational factors and interactions between professional work and tools used for fetal monitoring.ConclusionReducing avoidable harm associated with electronic fetal monitoring requires a systems approach based on a sound understanding of the full range of influences on practice.

ObjectiveWhen 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.DesignWe undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each ‘case’ was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.SettingTertiary referral National Health Service maternity unit in the Southwest of England.ParticipantsWomen requiring a clinically indicated assisted vaginal birth.InterventionThe Odon Device, an innovative device for assisted vaginal birth.Primary and secondary outcome measuresDetermining the optimal device technique, device design and defining clinical parameters for use.ResultsThirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.ConclusionsCase study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice.Trial registration numberISRCTN10203171.

In Zimbabwe, many health facilities are not able to manage serious obstetric complications. Staff most commonly identified inadequate training as the greatest barrier to preventing avoidable maternal deaths. We established an onsite obstetric emergencies training programme for maternity staff in the Mpilo Central Hospital. We trained 12 local staff to become trainers and provided them with the equipment and resources needed for the course. The trainers held one-day courses for 299 staff at the hospital. Maternal mortality in Zimbabwe has increased from 555 to 960 per 100,000 pregnant women from 2006 to 2011 and 47% of the deaths are believed to be avoidable. Most obstetric emergencies trainings are held off-site, away from the clinical area, for a limited number of staff. Following an in-hospital train-the-trainers course, 90% (138/153) of maternity staff were trained locally within the first year, with 299 hospital staff trained to date. Local system changes included: the introduction of a labour ward board, emergency boxes, colour-coded early warning observation charts and a maternity dashboard. In this hospital, these changes have been associated with a 34% reduction in hospital maternal mortality from 67 maternal deaths per 9078 births (0.74%) in 2011 compared with 48 maternal deaths per 9884 births (0.49%) in 2014. Introducing obstetric emergencies training and tools was feasible onsite, improved clinical practice, was sustained by local staff and associated with improved clinical outcomes. Further work to study the implementation and effect of this intervention at scale is required.

ObjectivesDetecting and responding to deterioration of a baby during labour is likely to benefit from a standardised approach supported by principles of track-and-trigger systems. To inform co-design of a standardised approach and associated implementation strategies, we sought the views of UK-based maternity professionals.DesignTwo successive cross-sectional surveys were hosted on an online collaboration platform (Thiscovery) between July 2021 and April 2022.SettingUK.ParticipantsAcross both surveys, 765 UK-based maternity professionals.Primary and secondary outcome measuresCount and percentage of participants selecting closed-ended response options, and categorisation and counting of free-text responses.ResultsMore than 90% of participants supported the principle of a standardised approach that systematically considers a range of intrapartum risk factors alongside fetal heart rate features. Over 80% of participants agreed on the importance of a proposed set of evidence-based risk factors underpinning such an approach, but many (over 75%) also indicated a need to clarify the clinical definitions of the proposed risk factors. A need for clarity was also suggested by participants’ widely varying views on thresholds for actions of the proposed risk factors, particularly for meconium-stained liquor, rise in baseline fetal heart rate and changes in fetal heart rate variability. Most participants (>75%) considered a range of resources to support good practice as very useful when implementing the approach, such as when and how to escalate in different situations (82%), how to create a supportive culture (79%) and effective communication and decision-making with those in labour and their partners (75%).ConclusionsWe found strong professional support for the principle of a standardised approach to detection and response to intrapartum fetal deterioration and high agreement on the clinical importance of a set of evidence-based risk factors. Further work is needed to address: (1) clarity of clinical definitions of some risk factors, (2) building evidence and agreement on thresholds for action and (3) deimplementation strategies for existing local practices.

ObjectiveTo 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.DesignQualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study.SettingA tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019.ParticipantsEight women, four operators and 11 midwives participated with eight observations of the assisted vaginal birth, eight interviews with women in the postnatal period, 39 interviews/reflections with operators and 19 interviews with midwives. Women in the case study research were recruited from participants in the main ASSIST Study.InterventionThe Odon Device, an innovative device for assisted vaginal birth.ResultsThirty-nine case studies were undertaken. Triangulation of data sources (participant observation, interviews with women, operators and midwives) enabled the exploration of women’s experiences of the Odon Device and recruitment in the intrapartum trial. Experiences were overwhelmingly positive. Women were motivated to take part by a wish for a kinder birth, and because they perceived both the recruitment and research processes (including observation) to be highly acceptable, regardless of whether the Odon-assisted birth was successful or not.ConclusionsInterviews and observations from multiple stakeholders enabled insight into women’s experiences of an innovative device for assisted vaginal birth. Applying these qualitative methods more broadly may illuminate perspectives of key stakeholders in future intrapartum intervention research and beyond.Trial registration numberISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.

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. However, before dissemination, the device requires evaluation in robust clinical trials. A feasibility study to investigate the clinical impact, safety, and acceptability of the BD Odon Device for assisted vaginal birth is therefore planned. This will provide further information on acceptability, recruitment, and the outcome data required to design a future randomised controlled trial of the BD Odon Device versus Kiwi ventouse. Methods Forty women who require an assisted vaginal birth for a recognised clinical indication will have the birth assisted with the BD Odon Device. The primary outcome is successful vaginal birth completed with the BD Odon Device. Secondary clinical outcomes include maternal and neonatal outcomes, and maternal and practitioner satisfaction. Safety data will be reviewed following every birth. Discussion A future randomised controlled trial of the BD Odon Device versus the current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the randomised controlled trial design. Trial registration ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018.

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. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. Methods The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A’Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. Discussion The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. Trial registration ISRCTN registration: 38829082 (prospectively registered July 26, 2019)

Approach We established an onsite obstetric emergencies training programme for maternity staff in the Mpilo Central Hospital. We trained 12 local staff to become trainers and provided them with the equipment and resources needed for the course. The trainers held one-day courses for 299 staff at the hospital. Approche Nous avons concu un programme local de formation aux urgences obstetricales, destine au personnel de la maternite de l'Hopital Central Mpilo. Nous avons forme 12 membres du personnel local pour assumer le role de formateurs et nous leur avons fourni tout le materiel et les ressources necessaires pourorganiser des formations. Ces formateurs ont dispense des cours de formation d'une journee a 299 membres du personnel de l'hopital.

BackgroundHigh-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it.MethodsThis UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers.FindingsParticipants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety.ConclusionsThis study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research.