Self-monitoring blood pressure in Pregnancy: Evaluation of health professional experiences of the BUMP trials.

BACKGROUND: The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether they improved detection or control of hypertension for women at risk of hypertension or with hypertension during pregnancy. This process evaluation aimed to understand healthcare professionals' perspectives and experiences of the BUMP trials of self-monitoring of blood pressure during pregnancy. METHODS: Twenty-two in-depth qualitative interviews and an online survey with 328 healthcare professionals providing care for pregnant people in the BUMP trials were carried out across five maternity units in England. RESULTS: Analysis used Normalisation Process Theory to identify factors required for successful implementation and integration into routine practice. Healthcare professionals felt self-monitoring of blood pressure did not over-medicalise pregnancy for women with, or at risk of, hypertension. Most said self-monitored readings positively affected their clinical encounters and professional roles, provided additive information on which to base decisions and enriched their relationships with pregnant people. Self-monitoring of blood pressure shifts responsibilities. Some healthcare professionals felt women having responsibility to decide on timing of monitoring and whether to act on self-monitored readings was unduly burdensome, and resulted in healthcare professionals taking additional responsibility for supporting them. CONCLUSIONS: Despite healthcare professionals' early concerns that self-monitoring of blood pressure might over-medicalise pregnancy, our analysis shows the opposite was the case when used in the care of pregnant people with, or at higher risk of, hypertension. While professionals retained ultimate clinical responsibility, they viewed self-monitoring of blood pressure as a means of sharing responsibility and empowering women to understand their bodies, to make judgements and decisions, and to contribute to their care.

Maternal satisfaction with group care: a systematic review.

OBJECTIVE: This review examined the quantitative relationship between group care and overall maternal satisfaction compared with standard individual care. DATA SOURCES: We searched CINAHL, Clinical Trials, The Cochrane Library, PubMed, Scopus, and Web of Science databases from the beginning of 2003 through June 2023. STUDY ELIGIBILITY CRITERIA: We included studies that reported the association between overall maternal satisfaction and centering-based perinatal care where the control group was standard individual care. We included randomized and observational designs. METHODS: Screening and independent data extraction were carried out by 4 researchers. We extracted data on study characteristics, population, design, intervention characteristics, satisfaction measurement, and outcome. Quality assessment was performed using the Cochrane tools for Clinical Trials (RoB2) and observational studies (ROBINS-I). We summarized the study, intervention, and satisfaction measurement characteristics. We presented the effect estimates of each study descriptively using a forest plot without performing an overall meta-analysis. Meta-analysis could not be performed because of variations in study designs and methods used to measure satisfaction. We presented studies reporting mean values and odds ratios in 2 separate plots. The presentation of studies in forest plots was organized by type of study design. RESULTS: A total of 7685 women participated in the studies included in the review. We found that most studies (ie, 17/20) report higher satisfaction with group care than standard individual care. Some of the noted results are lower satisfaction with group care in both studies in Sweden and 1 of the 2 studies from Canada. Higher satisfaction was present in 14 of 15 studies reporting CenteringPregnancy, Group Antenatal Care (1 study), and Adapted CenteringPregnancy (1 study). Although indicative of higher maternal satisfaction, the results are often based on statistically insignificant effect estimates with wide confidence intervals derived from small sample sizes. CONCLUSION: The evidence confirms higher maternal satisfaction with group care than with standard care. This likely reflects group care methodology, which combines clinical assessment, facilitated health promotion discussion, and community-building opportunities. This evidence will be helpful for the implementation of group care globally.

Community-based perinatal mental health peer support: a realist review.

BACKGROUND: Peer support has been suggested as an alternative or complement to professional support for mothers with perinatal mental health difficulties. The aim of this realist review was to synthesise the evidence on perinatal mental health peer support programmes outside mental health services, to understand what is it about community-based perinatal mental health peer support that works, for whom, in what circumstances, in what respects, and why. METHODS: Applying realist methodology, an initial theoretical model was tested against evidence from empirical studies. 29 empirical studies were included, covering 22 antenatal and postnatal mental health interventions that offered one-to-one or group peer support, in person or by telephone. Data extraction identified the configurations of contexts (C), mechanisms (M) and outcomes (O) relevant to mothers' use of peer support and to the positive and negative effects of using peer support. RESULTS: 13 C-M-O configurations explained take-up of peer support. These were based on mothers' perceptions that peer support would offer empathetic understanding and non-judgemental acceptance outside their social circle; their relationships with primary health professionals; their cultural background and perspectives on mental health; their desire for professional support; overcoming practical barriers; the format of the support; and the use of volunteers. A further 13 C-M-O configurations explained positive impact on mothers. These were based on receiving empathetic listening, acceptance, affirmation and normalisation; peers sharing ideas about self-care, coping, and services; peers using therapeutic techniques; the opportunity to give support to others; meaningful social relationships with volunteers and other mothers; and other benefits of attending a group. There were 8 C-M-O configurations explaining negative impact. These were based on lack of validation; self-criticism from downward and upward social comparison; a culture of negativity; peers being judgemental or directive; not feeling heard; peer support as a stressful social relationship; and distress at endings. CONCLUSIONS: Peer support works in complex ways that are affected by personal and social contexts. Providers, commissioners and evaluators can use this review to understand and maximise the valuable benefits of peer support, to minimise potential risks, and to devise ways of reaching mothers who do not currently engage with it.

Experience of induction of labour: a cross-sectional postnatal survey of women at UK maternity units.

OBJECTIVES: This study explored women's views and experiences of key elements of the induction of labour (IOL) process, including at home or in hospital cervical ripening (CR). DESIGN: A questionnaire-based postnatal survey undertaken as part of the CHOICE Study process evaluation. The questionnaire was administered online and included fixed response and free-text options. SETTING: National Health Service maternity units in the UK. PARTICIPANTS: 309 women who had an IOL. OUTCOME MEASURES: The primary outcome measure was experience of IOL. Few women returned home during CR, meaning that statistical comparison between those who experienced home-based and hospital-based CR was not possible. Findings are reported as descriptive statistics with content analysis of women's comments providing context. RESULTS: Information to support choice and understand what to expect about IOL is often inadequate or unavailable. Having IOL can create anxiety and remove options for birth that women had hoped would enhance their experience. Although it can provide a more comfortable environment, home CR is not always an acceptable solution. Women described maternity care negatively impacted by staffing shortages; delays to care sometimes led to unsafe situations. Women who had a positive experience of IOL described supportive interaction with staff as a significant contribution to that. CONCLUSIONS: Women do not experience IOL as a benign and consequence free intervention. There is urgent need for research to better target IOL and optimise safety and experience for women and their babies. Relatively few women were offered CR at home and further research is needed on this experience.

Clinicians' perspectives and experiences of providing cervical ripening at home or in-hospital in the United Kingdom.

Induction of labour, or starting labour artificially, is offered when the risks of continuing pregnancy are believed to outweigh the risks of the baby being born. In the United Kingdom, cervical ripening is recommended as the first stage of induction. Increasingly, maternity services are offering this outpatient or 'at home', despite limited evidence on its acceptability and how different approaches to cervical ripening work in practice. There is also a paucity of literature on clinicians' experiences of providing induction care in general, despite their central role in developing local guidelines and delivering this care. This paper explores induction, specifically cervical ripening and the option to return home during that process, from the perspective of midwives, obstetricians and other maternity staff. As part of a process evaluation involving five case studies undertaken in British maternity services, interviews and focus groups were conducted with clinicians who provide induction of labour care. The thematic findings were generated through in-depth analysis and are grouped to reflect key points within the process of cervical ripening care: 'Implementing home cervical ripening', 'Putting local policy into practice', 'Giving information about induction' and 'Providing cervical ripening'. A range of practices and views regarding induction were recorded, showing how the integration of home cervical ripening is not always straightforward. Findings demonstrate that providing induction of labour care is complex and represents a significant workload. Home cervical ripening was seen as a solution to managing this workload; however, findings highlighted ways in which this expectation might not be borne out in practice. More comprehensive research is needed on workload impacts and possible lateral effects within other areas of maternity services.

Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles.

BACKGROUND: Antenatal care has the potential to impact positively on maternal and child outcomes, but traditional models of care in the UK have been shown to have limitations and particularly for those from deprived populations. Group antenatal care is an alternative model to traditional individual care. It combines conventional aspects of antenatal assessment with group discussion and support. Delivery of group antenatal care has been shown to be successful in various countries; there is now a need for a formal trial in the UK. METHOD: An individual randomised controlled trial (RCT) of a model of group care (Pregnancy Circles) delivered in NHS settings serving populations with high levels of deprivation and diversity was conducted in an inner London NHS trust. This was an external pilot study for a potential fully powered RCT with integral economic evaluation. The pilot aimed to explore the feasibility of methods for the full trial. Inclusion criteria included pregnant with a due date in a certain range, 16 + years and living within specified geographic areas. Data were analysed for completeness and usability in a full trial; no hypothesis testing for between-group differences in outcome measures was undertaken. Pre-specified progression criteria corresponding to five feasibility measures were set. Additional aims were to assess the utility of our proposed outcome measures and different data collection routes. A process evaluation utilising interviews and observations was conducted. RESULTS: Seventy-four participants were randomised, two more than the a priori target. Three Pregnancy Circles of eight sessions each were run. Interviews were undertaken with ten pregnant participants, seven midwives and four other stakeholders; two observations of intervention sessions were conducted. Progression criteria were met at sufficient levels for all five measures: available recruitment numbers, recruitment rate, intervention uptake and retention and questionnaire completion rates. Outcome measure assessments showed feasibility and sufficient completion rates; the development of an economic evaluation composite measure of a 'positive healthy birth' was initiated. CONCLUSION: Our pilot findings indicate that a full RCT would be feasible to conduct with a few adjustments related to recruitment processes, language support, accessibility of intervention premises and outcome assessment. TRIAL REGISTRATION: ISRCTN ISRCTN66925258. Retrospectively registered, 03 April 2017.

Implementing midwifery units in a European country: Situational analysis of an Italian case study.

INTRODUCTION: Strong evidence recommends midwifery-led care for women with uncomplicated pregnancies. International research is now focusing on how to implement midwifery models of care in countries where they are not well established. In Europe, many countries like Italy are promoting midwifery-led care in national guidelines but often struggle to apply this change in practice. METHODS: This study collected data on professional, organisational and service users' levels to conduct a situational analysis of an Italian service which is approaching the implementation of a midwifery unit. Participatory Action Research was used together with the support of the Consolidated Framework for Implementation Research to conduct data collection and analysis. RESULTS: Forty-eight participants amongst professionals (midwives, obstetricians and neonatologists) and at organisational level (midwifery leaders and medical directors) were recruited; secondary data on service users' views was analysed via regional online surveys. Barriers and facilitators to the implementation were identified to assess the readiness of the local context. CONCLUSIONS: This study is the first to include professionals, managers and service users in a European context such as Italy. Facilitators to the implementation of the alongside midwifery unit were found in national guidelines, allocated funding, collaborative engagement and medical support. Hierarchical structures, a prevalent medical model and lack of trust and awareness of the evidence of safety of midwifery-led models were main barriers.

Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

A feasibility study evaluating the uptake, effectiveness and acceptability of routine screening of pregnant migrants for latent tuberculosis infection in antenatal care: a research protocol.

INTRODUCTION: Globally, tuberculosis (TB) is a leading cause of death in women of reproductive age and there is high risk of reactivation of latent tuberculosis infection (LTBI) in pregnancy. The uptake of routine screening of migrants for LTBI in the UK in primary care is low. Antenatal care is a novel setting which could improve uptake and can lend insight into the feasibility and acceptability of offering opt-out screening for LTBI. METHODS AND ANALYSIS: This is an observational feasibility study with a nested qualitative component. The setting will be the antenatal clinics in three hospitals in East London, UK . Inclusion criteria are pregnant migrant women aged 16-35 years attending antenatal clinics who are from countries with a TB incidence of greater than 150/100 000 including sub-Saharan Africa, and who have been in the UK for less than 5 years. Participants will be offered LTBI screening with an opt-out interferon gamma release assay blood test, and be invited to complete a questionnaire. Both participants and healthcare providers will be invited to participate in semistructured interviews or focus groups to evaluate understanding, feasibility and acceptability of routine opt-out LTBI screening. The primary analysis will focus on estimating the uptake of the screening programme along with the corresponding 95% CI. Secondary analysis will focus on estimating the test positivity. Qualitative analysis will evaluate the acceptability of offering routine opt-out LTBI screening to participants and healthcare providers. ETHICS AND DISSEMINATION: The study has received the following approvals: Health Research Authority (IRAS 247388) and National Health Service Ethics Committee (19/LO/0557). The results will be made available locally to antenatal clinics and primary care physicians, nationally to NHS England and Public Health England and internationally through conferences and journals. TRIAL REGISTRATION NUMBER: NCT04098341.

Antenatal care policy in high-income countries with a universal health system: A scoping review.

The availability, effectiveness, and access to antenatal care are directly linked with good maternal and neonatal outcomes, making antenatal care an important determinant in health. But to be effective, care must always be appropriate, not excessive, not insufficient. Perinatal outcomes vary within and between countries, raising questions about practices, the use of best evidence in clinical decisions and the existence of clear and updated guidance. Through a scoping review methodology, this study aimed to map the available antenatal care policies for low-risk pregnant women in high-income countries with a universal health system, financed by the government through tax payments. Following searches on the main databases and grey literature, the authors identified and analysed ten antenatal care policies using a previously piloted datachart: Australia, Denmark, Finland, Iceland, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom. Some policies were over 10 years old, some recommendations did not present a rationale or context, others were outdated, or were simply different approaches in the absence of strong evidence. Whilst some recommendations were ubiquitous, others differed either in the recommendation provided, the timing, or the frequency. Similarly, we found wide variation in the methods/strategy used to support the recommendations provided. These results confirm that best evidence is not always assimilated into policies and clinical guidance. Further research crossing these differences with perinatal outcomes and evaluation of cost could be valuable to optimise guidance on antenatal care. Similarly, some aspects of care need further rigorous studies to obtain evidence of higher quality to inform recommendations.

What are the strategies for implementing primary care models in maternity? A systematic review on midwifery units.

BACKGROUND: Midwifery Units (MUs) are associated with optimal perinatal outcomes, improved service users' and professionals' satisfaction as well as being the most cost-effective option. However, they still do not represent the mainstream option of maternity care in many countries. Understanding effective strategies to integrate this model of care into maternity services could support and inform the MU implementation process that many countries and regions still need to approach. METHODS: A systematic search and screening of qualitative and quantitative research about implementation of new MUs was conducted (Prospero protocol reference: CRD42019141443) using PRISMA guidelines. Included articles were appraised using the CASP checklist. A meta-synthesis approach to analysis was used. No exclusion criteria for time or context were applied to ensure inclusion of different implementation attempts even under different historical and social circumstances. A sensitivity analysis was conducted to reflect the major contribution of higher quality studies. RESULTS: From 1037 initial citations, twelve studies were identified for inclusion in this review after a screening process. The synthesis highlighted two broad categories: implementation readiness and strategies used. The first included aspects related to cultural, organisational and professional levels of the local context whilst the latter synthesised the main actions and key points identified in the included studies when implementing MUs. A logic model was created to synthesise and visually present the findings. CONCLUSIONS: The studies selected were from a range of settings and time periods and used varying strategies. Nonetheless, consistencies were found across different implementation processes. These findings can be used in the systematic scaling up of MUs and can help in addressing barriers at system, service and individual levels. All three levels need to be addressed when implementing this model of care.

Optimal time intervals for vaginal breech births: a case-control study.

Background: Breech births are associated with a high rate of hypoxic injury, in part due to cord occlusion during emergence. Maximum time intervals and guidelines oriented toward earlier intervention have been proposed in a Physiological Breech Birth Algorithm. We wished to further test and refine the Algorithm for use in a clinical trial. Methods: We conducted a retrospective case-control study in a London teaching hospital, including 15 cases and 30 controls, during the period of April 2012 to April 2020. Our sample size was powered to test the hypothesis that exceeding recommended time limits is associated with neonatal admission or death. Data collected from intrapartum care records was analysed using SPSS v26 statistical software. Variables were intervals between the stages of labour and various stages of emergence (presenting part, buttocks, pelvis, arms, head). The chi-square test and odds ratios were used to determine association between exposure to the variables of interest and composite outcome. Multiple logistic regression was used to test the predictive value of delays defined as non-adherence the Algorithm. Results: Logistic regression modelling using the Algorithm time frames had an 86.8% accuracy, a sensitivity of 66.7% and a specificity of 92.3% for predicting the primary outcome. Delays between umbilicus and head >3 minutes (OR: 9.508 [95% CI: 1.390-65.046] p=0.022) and from buttocks on the perineum to head >7 minutes (OR: 6.682 [95% CI: 0.940-41.990] p=0.058) showed the most effect. Lengths of time until the first intervention were consistently longer among the cases. Delay in intervention was more common among cases than head or arm entrapment. Conclusion: Emergence taking longer than the limits recommended in the Physiological Breech Birth algorithm may be predictive of adverse outcomes. Some of this delay is potentially avoidable. Improved recognition of the boundaries of normality in vaginal breech births may help improve outcomes.

When babies are born bottom-first, there is a risk that the baby could be starved of oxygen during the birth. To help prevent this, researchers developed a flowchart to guide when to help a baby out, the Physiological Breech Birth Algorithm. The first version was based on a study of actual breech birth videos and recommends that the birth should be complete within 7-5-3 minutes from buttocks-pelvis-umbilicus visible. This is different from current national guidance not to intervene until 5 minutes after the baby's pelvis is born. We are using this new algorithm to guide midwives and doctors in the OptiBreech Care Trial, so we wanted to make sure it is safe and accurate.

A systematic review of providers' experiences of facilitating group antenatal care.

BACKGROUND: Group antenatal care is a rapidly expanding alternative antenatal care delivery model. Research has shown it to be a safe and effective care model for women, but less is known about the perspectives of the providers leading this care. This systematic review examined published literature that considered health care professionals' experiences of facilitating group antenatal care. METHODS: Systematic searches were conducted in seven databases (Cinahl, Medline, Psychinfo, Embase, Ovid Emcare, Global Health and MIDRS) in April 2020. Qualitative or mixed methods studies with a significant qualitative component were eligible for inclusion if they included a focus on the experiences of health care providers who had facilitated group antenatal care. Prisma screening guidelines were followed and study quality was critically appraised by three independent reviewers. The findings were synthesised thematically. RESULTS: Nineteen papers from nine countries were included. Three main themes emerged within provider experiences of group antenatal care. The first theme, 'Giving women the care providers feel they want and need', addresses richer use of time, more personal care, more support, and continuity of care. The second theme, 'Building skills and relationships', highlights autonomy, role development and hierarchy dissolution. The final theme, 'Value proposition of group antenatal care', discusses provider investment and workload. CONCLUSIONS: Health care providers' experience of delivering group antenatal care was positive overall. Opportunities to deliver high-quality care that benefits women and allows providers to develop their professional role were appreciated. Questions about the providers' perspectives on workload, task shifting, and the structural changes needed to support the sustainability of group antenatal care warrant further exploration.

Cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocol.

INTRODUCTION: The aim of the cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS). METHODS AND ANALYSIS: We will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks' gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost-utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained. RESEARCH ETHICS APPROVAL AND DISSEMINATION: CHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN32652461.

Women's experiences of outpatient induction of labour with double balloon catheter or prostaglandin pessary: A qualitative study.

BACKGROUND: One quarter to one third of women experience induction of labour. Outpatient induction of labour may be safe and effective but women's views of this setting and of different methods of induction are sparse. AIM: To explore women's experiences of outpatient induction of labour with either prostaglandin pessary or double balloon catheter. METHODS: Qualitative study using semi-structured, audio-recorded interviews with twenty-one women recruited to a feasibility trial of outpatient induction of labour. Transcripts were coded and analysed using a thematic framework approach. FINDINGS: Two key themes were identified. 'Ownership of induction of labour' concerned how women understood and experienced the induction of labour process and tried to maintain control of a procedure managed by medical professionals. Women felt unprepared for the steps in the process and for the time it would take. The balloon method was preferred as it was considered a gentler start to the process, although some women reported it was painful on insertion. 'Importance of place' reflected women's associations of the home with comfort, ease of support and distraction, and the hospital with safety yet also with discomfort and delays. DISCUSSION: This sample of women were keen to start induction without hormones. The randomised controlled trial design may have biased the sample towards women who wanted to experience the balloon method and outpatient setting where these were not usually offered, thus further cohort studies would be beneficial. CONCLUSIONS: Women were positive about experiencing the early stages of induction of labour at home with the balloon catheter.

A change laboratory for maternity care in Brazil: Pilot implementation of Mother Baby Friendly Birthing Initiative.

Disrespectful and abusive treatment of women during childbirth is a worldwide problem. This research aimed to develop and implement a Mother Baby-Friendly Hospital Initiative (MBFHI) in an academic maternity hospital in Brazil and evaluate how change could be sustained. Change Laboratory principles guided a process of action research, which was conducted between 2017 and 2019. Clinicians and managers joined the researchers in discussion sessions to redesign routines and care pathways. Observation, interviews, focus groups, and historical and documentary analysis provided information about the existing activity system, which we analysed qualitatively using MBFHI criteria to identify themes. Evidence of inappropriate obstetric interventions and impersonal interactions between clinicians and patients stimulated us to devise innovative solutions. The challenges identified by this exercise included: poor infrastructure and ambience; difficulty adhering to evidence-based protocols; social and professional hierarchies; and clinicians being poorly educated about women's rights. Although challenges remained, positive changes included a friendlier environment, improved patient privacy, and fewer unnecessary procedures. Resources released by these changes allowed us, collaboratively, to track the further implementation and sustainability of change. We conclude that the Change Laboratory can help motivated clinicians and managers humanise patients' experiences, make care more evidence-based, and expand learning of mother-friendly maternity care. Tensions and contradictions between education and patient care reported here may resonate in settings other than maternity care.

Relationships and trust: Two key pillars of a well-functioning freestanding midwifery unit.

BACKGROUND: Despite strong evidence supporting the expansion of midwife-led unit provision, as a result of optimal maternal and perinatal outcomes, cost-effectiveness, and positive service user and staff experiences, scaling-up has been slow. Systemic barriers associated with gender, professional, economic, cultural, and social factors continue to constrain the expansion of midwifery as a public health intervention globally. This article aimed to explore relationships and trust as key components of a well-functioning freestanding midwifery unit (FMU). METHOD(S): A critical realist ethnographic study of an FMU located in East London, England, was conducted over a period of 15 months. Recruitment of the 82 participants was purposive. Data collection included participant observation and semi-structured interviews, and data were analyzed thematically along with relevant local guidelines and documents. RESULTS: Twelve themes emerged. Relationships and Trust were identified as a core theme. The other 11 themes were grouped into six families, three of which: Ownership, Autonomy, and Continuous Learning; Team Spirit, Interdependency, and Power Relations; and Salutogenesis will be covered in this paper. The remaining three families: Friendly Environment; Having Time and Mindfulness; and Social Capital, will be covered in a separate paper. CONCLUSIONS: A relationship-based model of care was crucial for both the functioning of the FMU and service users' satisfaction and may offer a compelling response to high levels of stress and burnout among midwives.

Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff-a qualitative study.

OBJECTIVE: One in 20 women are affected by pre-eclampsia, a major cause of maternal and perinatal morbidity, death and premature birth worldwide. Diagnosis is made from monitoring blood pressure (BP) and urine and symptoms at antenatal visits after 20 weeks of pregnancy. There are no randomised data from contemporary trials to guide the efficacy of self-monitoring of BP (SMBP) in pregnancy. We explored the perspectives of maternity staff to understand the context and health system challenges to introducing and implementing SMBP in maternity care, ahead of undertaking a trial. DESIGN: Exploratory study using a qualitative approach. SETTING: Eight hospitals, English National Health Service. PARTICIPANTS: Obstetricians, community and hospital midwives, pharmacists, trainee doctors (n=147). METHODS: Semi-structured interviews with site research team members and clinicians, interviews and focus group discussions. Rapid content and thematic analysis undertaken. RESULTS: The main themes to emerge around SMBP include (1) different BP changes in pregnancy, (2) reliability and accuracy of BP monitoring, (3) anticipated impact of SMBP on women, (4) anticipated impact of SMBP on the antenatal care system, (5) caution, uncertainty and evidence, (6) concerns over action/inaction and patient safety. CONCLUSIONS: The potential impact of SMBP on maternity services is profound although nuanced. While introducing SMBP does not reduce the responsibility clinicians have for women's health, it may enhance the responsibilities and agency of pregnant women, and introduces a new set of relationships into maternity care. This is a new space for reconfiguration of roles, mutual expectations and the relationships between and responsibilities of healthcare providers and women. TRIAL REGISTRATION NUMBER: NCT03334149.