OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

BACKGROUND: The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle's effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. METHODS: OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by 'buddy' units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle's sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians' adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. DISCUSSION: OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle's clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable 'implementation blueprint' will be produced to inform development of future guidelines to prevent perineal trauma. TRIAL REGISTRATION: ISRCTN26523605.

The OASI care bundle quality improvement project: lessons learned and future direction.

Rising rates of obstetric anal sphincter injury (OASI) led to a collaborative effort by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) to develop and evaluate the OASI Care Bundle (OASI-CB). The OASI-CB comprises four practices (antenatal discussion about OASI, manual perineal protection, mediolateral episiotomy at 60° from the midline, and systematic examination of the perineum, vagina and ano-rectum after vaginal birth) and was initially implemented as part of a quality improvement (QI) project-"OASI1"-in 16 maternity units across Great Britain. Evaluation of the OASI1 project found that the care bundle reduced OASI rates and identified several barriers and enablers to implementation. This paper summarises the key findings, including strengths, limitations and lessons learned from the OASI1 QI project, and provides rationale for further evaluation of the OASI-CB.

Women's experiences of the OASI Care Bundle; a package of care to reduce severe perineal trauma.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injury (OASI) is a severe form of perineal trauma that can occur during vaginal birth. Long-term morbidities include anal incontinence and psychosocial disorders. To reduce these injuries within England, Scotland and Wales, the OASI Care Bundle was introduced to 16 maternity units (January 2017-March 2018). The OASI Care Bundle comprises four elements: (1) antenatal information, (2) manual perineal protection, (3) medio-lateral episiotomy (when indicated) and 4) recognition and diagnosis of tears. As part of the project evaluation, a qualitative study was conducted to explore women's experiences of the OASI Care Bundle. METHODS: Semi-structured interviews were conducted with women (n = 19) who received the OASI Care Bundle as part of their maternity care. This was to explore their experience of each element. A thematic analysis of the interview data was performed. RESULTS: Three themes were identified: (1) memories of touch, whereby women reported that a 'hands-on' approach to perineal protection was a positive experience; (2) midwife as a supportive guide, where women reported that good communication facilitated a calm birth and post-birth diagnosis; (3) education: women need more information about perineal trauma. CONCLUSION: This study contributes to the literature through its exploration of women's experiences of perineal protection techniques and diagnosis of perineal trauma. Interviewed women indicated that they did not experience any of the care bundle elements as an intrusion of their physical integrity. Additionally, an urgent need was identified for more information about perineal trauma in terms of risk, prevention and recovery.

Exploring clinicians' perspectives on the 'Obstetric Anal Sphincter Injury Care Bundle' national quality improvement programme: a qualitative study.

INTRODUCTION: Obstetric anal sphincter injuries (OASI) can have severe debilitating consequences to women and health systems. The OASI Care Bundle quality improvement programme was introduced in 16 maternity units across England, Scotland and Wales (January 2017 to March 2018) to address increasing OASI rates. OBJECTIVES: To explore clinicians' (midwives' and obstetricians') perspectives of the OASI Care Bundle with respect to (1) acceptability, (2) feasibility, and (3) sustainability. DESIGN: A qualitative exploratory study using focus groups methodology. SETTING: A total of 16 focus groups were conducted in 16 maternity units in England, Scotland and Wales where the OASI Care Bundle was implemented. Focus groups took place approximately 3 months following initial implementation of the care bundle in each unit. PARTICIPANTS: A total of 101 clinicians participated, with an average of six per focus group. Participants volunteered to take part and compromised of 37 obstetricians and 64 midwives (including eight students). The majority were female and the mean age was 36.5 years. RESULTS: Four main themes emerged: 'Implementation strategies', 'Opportunities to use the OASI Care Bundle', 'Does current practice need to change?' and 'Perceptions of what women want'. Midwives were more likely than obstetricians to report themes alluding to 'what women want' and variations in intrapartum perineal protection techniques. Both professional groups reported similar views of other themes, in particular regarding the supporting clinical evidence. Gaps were identified in clinicians' knowledge and experience of intrapartum perineal management. CONCLUSIONS: Adoption of the OASI Care Bundle was associated with a number of cognitive and interpersonal factors, such as personal values, interprofessional working and how the intervention was launched; which both facilitated and impeded adoption. The 'what women want' theme has implications for maternal autonomy and needs further exploration. Our findings can be used by similar initiatives to reduce perineal trauma both nationally and internationally. TRIAL REGISTRATION NUMBER: ISCTRN 12143325; https://doi.org/10.1186/ISRCTN12143325.

A multi-centre quality improvement project to reduce the incidence of obstetric anal sphincter injury (OASI): study protocol.

BACKGROUND: Third and fourth degree perineal tears, or obstetric anal sphincter injuries (OASI), sustained during childbirth can result in anal incontinence and psychosocial problems which require ongoing treatment. Within the English National Health System (NHS) reported rates of OASI have gradually increased. In response, a care bundle was developed incorporating four elements: 1) antenatal information to women, 2) manual perineal protection during all vaginal births, 3) episiotomy to be performed with a 60° mediolateral angle at crowning (when clinically indicated) and 4) perineal examination (including per rectum) after childbirth. Implementation of the OASI Care Bundle is aided by a skills development module and an awareness campaign. The project is a collaboration between two national professional bodies, an NHS hospital trust and an academic institution. METHODS: Implementation of the OASI Care Bundle will be evaluated using a stepped-wedge design. From January 2017 sixteen maternity units across England, Wales and Scotland will participate in the study over a 15-month period, with sequential roll-out of the intervention in four blocks (regions) of four units. The primary clinical outcome is OASI rate. Regression analysis will adjust for differences in organisational characteristics and obstetric risk factors in women who gave birth before and after implementation of the care bundle. Focus group discussions and in-depth interviews with clinicians will evaluate the feasibility of integrating the care bundle into routine practice. Interviews with women will explore the acceptability of the intervention. DISCUSSION: This protocol outlines the evaluation of our quality improvement project which aims to prevent OASI using a bundle of evidence-based interventions that are each widely used in practice. The OASI project aims to 1) standardise practice to prevent OASI in a way that is acceptable to clinicians and women and 2) identify the barriers and enablers associated with upscaling interventions within maternity units. If found to be effective, feasible and acceptable, the OASI Care Bundle will be shared with a range of audiences using the communication channels available to the professional bodies. TRIAL REGISTRATION: The OASI Project was retrospectively registered on the ISCTRN12143325 database date assigned 03/10/2017.

Vaccination in pregnancy: Attitudes of nurses, midwives and health visitors in England.

OBJECTIVE: To examine amongst healthcare professionals in England; knowledge of vaccinations in pregnancy, their perceived roles in these programmes and whether they recommend scheduled vaccines to pregnant women. DESIGN: Cross sectional survey (online questionnaire) Setting: Healthcare workers in contact with pregnant women in England. PARTICIPANTS: The survey analysis included 3441 healthcare workers who had been surveyed during May to August 2015. The participants were midwives, practice nurses and health visitors, working in England who were members of the Royal College of Midwives, Royal College of Nursing and the Institute of Health Visiting. RESULTS: We found that knowledge of vaccination in pregnancy was high in all professional groups. Seventy three percent of all respondents would recommend the influenza vaccine and 74% would recommend the pertussis vaccine to pregnant women. They were more likely to recommend vaccination in pregnancy if they would personally have the influenza and pertussis vaccines themselves and/or if they had the influenza vaccine as a healthcare worker. Practice nurses were significantly more likely to recommend the pertussis and influenza vaccines to pregnant women than midwives and health visitors. Health professionals who had received immunisation training were more confident in giving advice to pregnant women. CONCLUSION: Immunisation training is essential if healthcare workers are to be informed and confident in effectively delivering the maternal immunisation programme and thus improving uptake of vaccines in pregnancy. These findings are important in tailoring educational programmes and addressing the training needs of different healthcare professional groups.

Service configuration, unit characteristics and variation in intervention rates in a national sample of obstetric units in England: an exploratory analysis.

OBJECTIVES: To explore whether service configuration and obstetric unit (OU) characteristics explain variation in OU intervention rates in 'low-risk' women. DESIGN: Ecological study using funnel plots to explore unit-level variations in adjusted intervention rates and simple linear regression, stratified by parity, to investigate possible associations between unit characteristics/configuration and adjusted intervention rates in planned OU births. Characteristics considered: OU size, presence of an alongside midwifery unit (AMU), proportion of births in the National Health Service (NHS) trust planned in midwifery units or at home and midwifery 'under' staffing. SETTING: 36 OUs in England. PARTICIPANTS: 'Low-risk' women with a 'term' pregnancy planning vaginal birth in a stratified, random sample of 36 OUs. MAIN OUTCOME MEASURES: Adjusted rates of intrapartum caesarean section, instrumental delivery and two composite measures capturing birth without intervention ('straightforward' and 'normal' birth). RESULTS: Funnel plots showed unexplained variation in adjusted intervention rates. In NHS trusts where proportionately more non-OU births were planned, adjusted intrapartum caesarean section rates in the planned OU births were significantly higher (nulliparous: R(2)=31.8%, coefficient=0.31, p=0.02; multiparous: R(2)=43.2%, coefficient=0.23, p=0.01), and for multiparous women, rates of 'straightforward' (R(2)=26.3%, coefficient=-0.22, p=0.01) and 'normal' birth (R(2)=17.5%, coefficient=0.24, p=0.01) were lower. The size of the OU (number of births), midwifery 'under' staffing levels (the proportion of shifts where there were more women than midwives) and the presence of an AMU were associated with significant variation in some interventions. CONCLUSIONS: Trusts with greater provision of non-OU intrapartum care may have higher intervention rates in planned 'low-risk' OU births, but at a trust level this is likely to be more than offset by lower intervention rates in planned non-OU births. Further research using high quality data on unit characteristics and outcomes in a larger sample of OUs and trusts is required.

Duration and urgency of transfer in births planned at home and in freestanding midwifery units in England: secondary analysis of the birthplace national prospective cohort study.

BACKGROUND: In England, there is a policy of offering healthy women with straightforward pregnancies a choice of birth setting. Options may include home or a freestanding midwifery unit (FMU). Transfer rates from these settings are around 20%, and higher for nulliparous women. The duration of transfer is of interest because of the potential for delay in access to specialist care and is also of concern to women. We aimed to estimate the duration of transfer in births planned at home and in FMUs and explore the effects of distance and urgency on duration. METHODS: This was a secondary analysis of data collected in a national prospective cohort study including 27,842 'low risk' women with singleton, term, 'booked' pregnancies, planning birth in FMUs or at home in England from April 2008 to April 2010. We described transfer duration using the median and interquartile range, for all transfers and those for reasons defined as potentially urgent or non-urgent, and used cumulative distribution curves to compare transfer duration by urgency. We explored the effect of distance for transfers from FMUs and described outcomes in women giving birth within 60 minutes of transfer. RESULTS: The median overall transfer time, from decision to transfer to first OU assessment, was shorter in transfers from home compared with transfers from FMUs (49 vs 60 minutes; p < 0.001). The median duration of transfers before birth for potentially urgent reasons (home 42 minutes, FMU 50 minutes) was 8-10 minutes shorter compared with transfers for non-urgent reasons. In transfers for potentially urgent reasons, the median overall transfer time from FMUs within 20 km of an OU was 47 minutes, increasing to 55 minutes from FMUs 20-40 km away and 61 minutes in more remote FMUs. In women who gave birth within 60 minutes after transfer, adverse neonatal outcomes occurred in 1-2% of transfers. CONCLUSIONS: Transfers from home or FMU commonly take up to 60 minutes from decision to transfer, to first assessment in an OU, even for transfers for potentially urgent reasons. Most transfers are not urgent and emergencies and adverse outcomes are uncommon, but urgent transfer is more likely for nulliparous women.

Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study.

OBJECTIVE: To compare perinatal outcomes, maternal outcomes, and interventions in labour by planned place of birth at the start of care in labour for women with low risk pregnancies. DESIGN: Prospective cohort study. SETTING: England: all NHS trusts providing intrapartum care at home, all freestanding midwifery units, all alongside midwifery units (midwife led units on a hospital site with an obstetric unit), and a stratified random sample of obstetric units. PARTICIPANTS: 64,538 eligible women with a singleton, term (≥37 weeks gestation), and "booked" pregnancy who gave birth between April 2008 and April 2010. Planned caesarean sections and caesarean sections before the onset of labour and unplanned home births were excluded. MAIN OUTCOME MEASURE: A composite primary outcome of perinatal mortality and intrapartum related neonatal morbidities (stillbirth after start of care in labour, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus, or fractured clavicle) was used to compare outcomes by planned place of birth at the start of care in labour (at home, freestanding midwifery units, alongside midwifery units, and obstetric units). RESULTS: There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5). Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units. For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting. For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. Interventions during labour were substantially lower in all non-obstetric unit settings. Transfers from non-obstetric unit settings were more frequent for nulliparous women (36% to 45%) than for multiparous women (9% to 13%). CONCLUSIONS: The results support a policy of offering healthy women with low risk pregnancies a choice of birth setting. Women planning birth in a midwifery unit and multiparous women planning birth at home experience fewer interventions than those planning birth in an obstetric unit with no impact on perinatal outcomes. For nulliparous women, planned home births also have fewer interventions but have poorer perinatal outcomes.