Dataset Information

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.

ABSTRACT:

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.

Participants

Eight 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.

Intervention

The Odon Device, an innovative device for assisted vaginal birth.

Results

Thirty-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.

Conclusions

Interviews 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 number

ISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.

SUBMITTER: Hotton EJ

PROVIDER: S-EPMC8679107 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:BackgroundThe 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.MethodsThe 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%.DiscussionThe 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 registrationISRCTN registration: 38829082 (prospectively registered July 26, 2019).

Project description:BackgroundAs maternity services evolve and the population of women served also changes, there is a continuing need to effectively document the views of women with recent experience of care. A woman's maternity experience can have a positive or negative effect upon her emotional well-being and health, in the immediate and the long-term, which can also impact the infant and the wider family system. Measuring women's perceptions of maternity services is an important way of monitoring the quality of care provision, as well as providing key indicators to organisations of the services that they are providing. It follows that, without information identifying possible areas in need of improvement, it is not clear what changes should be made to improve the experiences of women during their journey through maternity services from pregnancy to the early weeks at home with a new baby . The objective is to describe the development process and psychometric properties of a measure of women's experience of maternity care covering the three distinctly different phases of maternity - pregnancy, labour and birth, and the early postnatal period.MethodsData from a national survey of women who had recently given birth (n = 504) were used. Exploratory and confirmatory factor analytic methods were employed. The measure was assessed for underlying latent factor structure, as well as for reliability, internal consistency, and validity (predictive, convergent and discriminant).ResultsThe models developed confirmed the use of three separate, but related scales about experience of maternity care during pregnancy, labour and birth and the postnatal period. Data reduction was effective, resulting in a measure with 36 items (12 per scale).ConclusionThe need for a psychometrically robust and qualitatively comprehensive measure of women's experience of maternity care has been addressed in the development and validation of this prototype measure. The whole measure can be used at one time point, or the three separate subscales used as individual measures of experience during particular phases of the maternity journey with identified factor structures in their own right.

Project description:BACKGROUND:Maternity Waiting Homes (MWHs) have been advocated to improve the utilization of skilled birth attendants. Nevertheless, delivery attended by skilled personnel is low in Ethiopia and may indicate that the utilization of MWH is also low. The aim of this study is to explore the factors influencing women's access to the MWHs in rural Southwest Ethiopia. METHODS:Qualitative data were collected through focus group discussions with MWHs users and in-depth interviews with MWHs non-users, health extension workers and the clinicians. Four focus group discussions and 18 in-depth interviews were conducted between May 1 and June 1, 2017. Furthermore, observations were made to assess the availability of basic facilities at selected MWHs. Data were thematically analyzed using NVivo version 7. The concept of access defined by Thiede et al was applied to guide the analysis. RESULTS:Women had interest on MWHs and are aware of the existence of MWHs in their immediate vicinity. Health information disseminations and referral linkages by frontline health workers enabled women to timely access the MWHs. However, Women didn't understand the aims and benefits of MWHs. At the facility level, there were attempts to improve the acceptability of MWHs by allowing women to choose their delivery positions. But, participants claimed lack of privacy and presence of disrespectful care. Physical barriers (long distance, unavailability of transport options & unfavorable roads) were considered as potential problems for women residing in remote areas. MWH users mentioned absences of sufficient basic facilities, poor quality and varieties of food. Because of insufficient facilities, the cost of living was high for most users. The communities try to overcome the indirect costs through contributions in-kind and in-cash. CONCLUSIONS:The factors influencing women's access to the MWHs were structural and individual and resonate with Thiede et al. dimensions of access. A better understanding of which factors are most influential in preventing women's access to the MWHs in rural Southwest Ethiopia is needed to appropriately target interventions.

Project description:BackgroundNo 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.ObjectiveThis study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study.Study designThis is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90.ResultsBetween October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention-the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator).ConclusionRecruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

Project description:BackgroundVaginal birth after caesarean (VBAC) is a safe mode of birth for most women but internationally VBAC rates remain low. In Australia women planning a VBAC may experience different models of care including continuity of care (CoC). There are a limited number of studies exploring the impact and influence of CoC on women's experiences of planning a VBAC. Continuity of care (CoC) with a midwife has been found to increase spontaneous vaginal birth and decrease some interventions. Women planning a VBAC prefer and benefit from CoC with a known care provider. This study aimed to explore the influence, and impact, of continuity of care on women's experiences when planning a VBAC in Australia.MethodsThe Australian VBAC survey was designed and distributed via social media. Outcomes and experiences of women who had planned a VBAC in the past 5?years were compared by model of care. Standard fragmented maternity care was compared to continuity of care with a midwife or doctor.ResultsIn total, 490 women completed the survey and respondents came from every State and Territory in Australia. Women who had CoC with a midwife were more likely to feel in control of their decision making and feel their health care provider positively supported their decision to have a VBAC. Women who had CoC with a midwife were more likely to have been active in labour, experience water immersion and have an upright birthing position. Women who received fragmented care experienced lower autonomy and lower respect compared to CoC.ConclusionThis study recruited a non-probability based, self-selected, sample of women using social media. Women found having a VBAC less traumatic than their previous caesarean and women planning a VBAC benefited from CoC models, particularly midwifery continuity of care. Women seeking VBAC are often excluded from these models as they are considered to have risk factors. There needs to be a focus on increasing shared belief and confidence in VBAC across professions and an expansion of midwifery led continuity of care models for women seeking a VBAC.

Project description:Minoritised ethnic perinatal women can experience judgemental and stigmatising care due to systemic racism. Discriminatory care contributes to increased risks of poor maternal and infant outcomes, including higher rates of mental ill-health. This study aimed to explore minoritised ethnic women's experiences of maternity services, including maternity care and mental health support, within a North-West England locality. Here we use an equity lens to report the findings that describe if and how women's personal, cultural, and spiritual needs were met, their experiences of discriminatory and prejudicial care, and to identify recommendations for service provision. A mixed-methods study was undertaken comprising an online survey, interviews, and community consultations. Questions explored access to and experiences of antenatal care and education; information, communication, and choice; experiences of (dis)respect and judgement; mental health needs and support; cultural/religious needs and support; and overall experiences of maternity care. Eligibility criteria were: women, 18+ years, from self-reported minoritised ethnic backgrounds, who had given birth in the previous 2 years and received maternity care in the locality. Surveys were available in seven languages and distributed via social media, mother-baby groups, and community locations. English-speaking survey participants were invited to take part in a follow-up interview. Community staff were approached to collect data on behalf of the study team. Quantitative data were analysed descriptively (n, %) and merged with qualitative data into descriptive themes. Overall, 104 women provided data; most self-identified as Asian (65.0%) or Black (10.7%) and were aged between 30-34 (32.0%) or 25-29 years (23.3%). Four descriptive themes are reported: 'accessing care' details variations and barriers in accessing maternity care; 'communication needs, and resources' describes views on adaptions and resources for specific communication needs; 'meeting religious and cultural needs' outlines how various religious and cultural needs were met by maternity providers; 'discriminatory or stigmatising care' reports on experiences of pejorative and inequitable care. An equity lens helped identify areas of discriminatory and inequitable care. Key recommendations include cultural safety training for staff; service-user engagement and co-production of research and resources, and appropriate facilities and recording systems to facilitate individualised, needs-based maternity care.