Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study.

OBJECTIVE: To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes. DESIGN: A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation. SETTING: Three inner-city UK National Health Service hospitals in London. PARTICIPANTS: Pregnant women with gestational diabetes treated with medication. INTERVENTIONS: 2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally. PRIMARY OUTCOME MEASURES: Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention. SECONDARY OUTCOME MEASURES: Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs. RESULTS: Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders. CONCLUSIONS: It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention. TRIAL REGISTRATION NUMBER: ISRCTN20930880.

Development, acceptability and feasibility of a community-based intervention to increase timely initiation of antenatal care in an area of high ethnic diversity and low socio-economic status in the UK.

BACKGROUND: Antenatal care plays an important role in preventing adverse maternal and new-born outcomes. Women from ethnic minority backgrounds and of low socio-economic status are at greater risk of initiating antenatal care later than the recommended 10 weeks. There is a paucity of research exploring the development and evaluation of community-based interventions to increase the timely initiation of antenatal care. OBJECTIVE: To develop and evaluate the acceptability and feasibility of a co-produced community-based intervention to increase uptake of antenatal care in an area with high ethnic diversity and low socio-economic status. DESIGN: The intervention was developed using co-production workshops and conversations with 20 local service users and 14 stakeholders, underpinned by the theory of Diffusion of Innovation. The intervention was evaluated, on the domains of acceptability, adoption, appropriateness, and feasibility. Questionnaires (n=36), interviews (n=10), and focus groups (n=13) were conducted among those who received the intervention. Observations (n=13) of intervention sessions were conducted to assess intervention fidelity. Quantitative and qualitative data were analysed using SPSS and NVivo software respectively. RESULTS: Over 91% of respondents positively ranked the intervention. Qualitative findings with respect to 'acceptability' included four subthemes: how the intervention was communicated, the characteristics of the person delivering the intervention and their knowledge, and the reassurance offered by the intervention. The 'adoption' theme included three sub-themes: being informed helps women to engage with antenatal care, the intervention provides information for future use, and onwards conveyance of the intervention information. The 'appropriateness' theme included three sub-themes: existing gap in information, nature of information given as part of the intervention, and talking about pregnancy in public. The 'feasibility' theme included two sub-themes: value of delivering the intervention in areas of high footfall and relational aspect of receiving the intervention. Observations showed intervention fidelity of 100%. CONCLUSION: The community-based intervention, coproduced with women and maternity care stakeholders, was positively evaluated, and offered an innovative and promising approach to engage and educate women about the timely initiation of antenatal care in an ethnically diverse and socio-economically deprived community.

Ethnic minority women's experiences of accessing antenatal care in high income European countries: a systematic review.

BACKGROUND: Women from ethnic minority backgrounds are at greater risk of adverse maternal outcomes. Antenatal care plays a crucial role in reducing risks of poor outcomes. The aim of this study was to identify, appraise, and synthesise the recent qualitative evidence on ethnic minority women's experiences of accessing antenatal care in high-income European countries, and to develop a novel conceptual framework for access based on women's perspectives. METHODS: We conducted a comprehensive search of seven electronic databases in addition to manual searches to identify all qualitative studies published between January 2010 and May 2021. Identified articles were screened in two stages against the inclusion criteria with titles and abstracts screened first followed by full-text screening. Included studies were quality appraised using the Critical Appraisal Skills Programme checklist and extracted data were synthesised using a 'best fit' framework, based on an existing theoretical model of health care access. RESULTS: A total of 30 studies were included in this review. Women's experiences covered two overarching themes: 'provision of antenatal care' and 'women's uptake of antenatal care'. The 'provision of antenatal care' theme included five sub-themes: promotion of antenatal care importance, making contact and getting to antenatal care, costs of antenatal care, interactions with antenatal care providers and models of antenatal care provision. The 'women's uptake of antenatal care' theme included seven sub-themes: delaying initiation of antenatal care, seeking antenatal care, help from others in accessing antenatal care, engaging with antenatal care, previous experiences of interacting with maternity services, ability to communicate, and immigration status. A novel conceptual model was developed from these themes. CONCLUSION: The findings demonstrated the multifaceted and cyclical nature of initial and ongoing access to antenatal care for ethnic minority women. Structural and organisational factors played a significant role in women's ability to access antenatal care. Participants in majority of the included studies were women newly arrived in the host country, highlighting the need for research to be conducted across different generations of ethnic minority women taking into account the duration of stay in the host country where they accessed antenatal care. PROTOCOL AND REGISTRATION: The review protocol was registered on PROSPERO (reference number CRD42021238115).

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.

Project20: maternity care mechanisms that improve access and engagement for women with social risk factors in the UK - a mixed-methods, realist evaluation.

OBJECTIVES: To evaluate how women access and engage with different models of maternity care, whether specialist models improve access and engagement for women with social risk factors, and if so, how? DESIGN: Realist evaluation. SETTING: Two UK maternity service providers. PARTICIPANTS: Women accessing maternity services in 2019 (n=1020). METHODS: Prospective observational cohort with multinomial regression analysis to compare measures of access and engagement between models and place of antenatal care. Realist informed, longitudinal interviews with women accessing specialist models of care were analysed to identify mechanisms. MAIN OUTCOME MEASURES: Measures of access and engagement, healthcare-seeking experiences. RESULTS: The number of social risk factors women were experiencing increased with deprivation score, with the most deprived more likely to receive a specialist model that provided continuity of care. Women attending hospital-based antenatal care were more likely to access maternity care late (risk ratio (RR) 2.51, 95% CI 1.33 to 4.70), less likely to have the recommended number of antenatal appointments (RR 0.61, 95% CI 0.38 to 0.99) and more likely to have over 15 appointments (RR 4.90, 95% CI 2.50 to 9.61) compared with community-based care. Women accessing standard care (RR 0.02, 95% CI 0.00 to 0.11) and black women (RR 0.02, 95% CI 0.00 to 0.11) were less likely to have appointments with a known healthcare professional compared with the specialist model. Qualitative data revealed mechanisms for improved access and engagement including self-referral, relational continuity with a small team of midwives, flexibility and situating services within deprived community settings. CONCLUSION: Inequalities in access and engagement with maternity care appears to have been mitigated by the community-based specialist model that provided continuity of care. The findings enabled the refinement of a realist programme theory to inform those developing maternity services in line with current policy.

Project20: Maternity care mechanisms that improve (or exacerbate) health inequalities. A realist evaluation.

BACKGROUND: Women with low socioeconomic status and social risk factors are at a disproportionate risk of poor birth outcomes and experiences of maternity care. Specialist models of maternity care that offer continuity are known to improve outcomes but underlying mechanisms are not well understood. AIM: To evaluate two UK specialist models of care that provide continuity to women with social risk factors and identify specific mechanisms that reduce, or exacerbate, health inequalities. METHODS: Realist informed interviews were undertaken throughout pregnancy and the postnatal period with 20 women with social risk factors who experienced a specialist model of care. FINDINGS: Experiences of stigma, discrimination and paternalistic care were reported when women were not in the presence of a known midwife during care episodes. Practical and emotional support, and evidence-based information offered by a known midwife improved disclosure of social risk factors, eased perceptions of surveillance and enabled active participation. Continuity of care offered reduced women's anxiety, enabled the development of a supportive network and improved women's ability to seek timely help. Women described how specialist model midwives knew their medical and social history and how this improved safety. Care set in the community by a team of six known midwives appeared to enhance these benefits. CONCLUSION: The identification of specific maternity care mechanisms supports current policy initiatives to scale up continuity models and will be useful in future evaluation of services for marginalised groups. However, the specialist models of care cannot overcome all inequalities without improvements in the maternity system as a whole.

Disparities in the timing of antenatal care initiation and associated factors in an ethnically dense maternal cohort with high levels of area deprivation.

BACKGROUND: Late access to antenatal care is a contributor to excess mortality and morbidity among ethnic minority mothers compared to White British in the UK. While individual ethnicity and socioeconomic disadvantage are linked to late antenatal care initiation, studies have seldom explored patterns of late initiation and associated factors in ethnically dense socially disadvantaged settings. This study investigated disparities in the timing of antenatal care initiation, and associated factors in an ethnically dense socially disadvantaged maternal cohort. METHODS: A retrospective cross-sectional study using routinely collected anonymous data on all births between April 2007-March 2016 in Luton and Dunstable hospital, UK (N = 46,307). Late initiation was defined as first antenatal appointment attended at > 12 weeks of gestation and further classified into moderately late (13-19 weeks) and extremely late initiation (≥ 20 weeks). We applied logistic and multinomial models to examine associations of late initiation with maternal and sociodemographic factors. RESULTS: Overall, one fifth of mothers (20.8%) started antenatal care at > 12 weeks of gestation. Prevalence of late initiation varied across ethnic groups, from 16.3% (White British) to 34.2% (Black African). Late initiation was strongly associated with non-White British ethnicity. Compared to White British mothers, the odds of late initiation and relative risk of extremely late initiation were highest for Black African mothers [adjusted OR = 3.37 (3.05, 3.73) for late initiation and RRR = 4.03 (3.51, 4.64) for extremely late initiation]. The odds did not increase with increasing area deprivation, but the relative risk of moderately late initiation increased in the most deprived ([RRR = 1.53 (1.37, 1.72)] and second most deprived areas [RRR = 1.23 (1.10, 1.38)]. Late initiation was associated with younger mothers and to a lesser extent, older mothers aged > 35 years. Mothers who smoked during pregnancy were at higher odds of late initiation compared to mothers who did not smoke. CONCLUSIONS: There is a need to intensify universal and targeted programmes/services to support mothers in ethnically dense socially disadvantaged areas to start antenatal care on time. Local variations in ethnic diversity and levels of social disadvantage are essential aspects to consider while planning services and programmes to ensure equity in maternity care provision.

Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the ACROBAT pilot trial for severe postpartum haemorrhage.

OBJECTIVE: The ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial. SETTING: Qualitative interview study within a cluster-randomised pilot trial, involving four London maternity services. PARTICIPANTS: Individual interviews were conducted postnatally with 10 women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four 'recruiters'-two research midwives and two clinical trials practitioners who conducted trial recruitment. RESULTS: Consent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data. CONCLUSION: Our findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring-that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand. TRIAL REGISTRATION NUMBER: ISRCTN12146519.

Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study.

OBJECTIVES: To determine the feasibility and acceptability of conducting a randomised trial on the effects of myo-inositol in preventing gestational diabetes in high-risk pregnant women. DESIGN: A multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation. SETTING: Five inner city UK National Health Service hospitals PARTICIPANTS: Multiethnic pregnant women at 12+0 and 15+6 weeks' gestation with risk factors for gestational diabetes. INTERVENTIONS: 2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery. PRIMARY OUTCOME MEASURES: Rates of recruitment, randomisation, adherence and follow-up. SECONDARY OUTCOME MEASURES: Glycaemic indices (including homoeostatic model assessment-insulin resistance HOMA-IR), gestational diabetes (diagnosed using oral glucose tolerance test at 28 weeks and by delivery), maternal, perinatal outcomes, acceptability of intervention and costs. RESULTS: Of the 1326 women screened, 58% (773/1326) were potentially eligible, and 27% (205/773) were recruited. We randomised 97% (198/205) of all recruited women (99 each in intervention and placebo arms) and ascertained outcomes in 90% of women (178/198) by delivery. The mean adherence was 52% (SD 44) at 28 weeks' and 34% (SD 41) at 36 weeks' gestation. HOMA-IR and serum insulin levels were lower in the myo-inositol vs placebo arm (mean difference -0.6, 95% CI -1.2 to 0.0 and -2.69, 95% CI -5.26 to -0.18, respectively). The study procedures were acceptable to women and healthcare professionals. Women who perceived themselves at high risk of gestational diabetes were more likely to participate and adhere to the intervention. The powder form of myo-inositol and placebo, along with nausea in pregnancy were key barriers to adherence. CONCLUSIONS: A future trial on myo-inositol versus placebo to prevent gestational diabetes is feasible. The intervention will need to be delivered in a non-powder form to improve adherence. There is a signal for efficacy in reducing insulin resistance in pregnancy with myo-inositol. TRIAL REGISTRATION NUMBER: ISRCTN48872100.

Project20: interpreter services for pregnant women with social risk factors in England: what works, for whom, in what circumstances, and how?

BACKGROUND: Black and minority ethnic women and those with social risk factors such as deprivation, refugee and asylum seeker status, homelessness, mental health issues and domestic violence are at a disproportionate risk of poor birth outcomes. Language barriers further exacerbate this risk, with women struggling to access, engage with maternity services and communicate concerns to healthcare professionals. To address the language barrier, many UK maternity services offer telephone interpreter services. This study explores whether or not women with social risk factors find these interpreter services acceptable, accessible and safe, and to suggest solutions to address challenges. METHODS: Realist methodology was used to refine previously constructed programme theories about how women with language barriers access and experience interpreter services during their maternity care. Twenty-one longitudinal interviews were undertaken during pregnancy and the postnatal period with eight non-English speaking women and their family members. Interviews were analysed using thematic framework analysis to confirm, refute or refine the programme theories and identify specific contexts, mechanisms and outcomes relating to interpreter services. RESULTS: Women with language barriers described difficulties accessing maternity services, a lack of choice of interpreter, suspicion around the level of confidentiality interpreter services provide, and questioned how well professional interpreters were able to interpret what they were trying to relay to the healthcare professional during appointments. This resulted in many women preferring to use a known and trusted family member or friend to interpret for them where possible. Their insights provide detailed insight into how poor-quality interpreter services impact on their ability to disclose risk factors and communicate concerns effectively with their healthcare providers. A refined programme theory puts forward mechanisms to improve their experiences and safety such as regulated, high-quality interpreter services throughout their maternity care, in which women have choice, trust and confidence. CONCLUSIONS: The findings of this study contribute to concerns highlighted in previous literature around interpreter services in the wider healthcare arena, particularly around the lack of regulation and access to high-quality interpretation. This is thought to have a significant effect on pregnant women who are living socially complex lives as they are not able to communicate their concerns and access support. This not only impacts on their safety and pregnancy outcomes, but also their wider holistic needs. The refined program theory developed in this study offers insights into the mechanisms of equitable access to appropriate interpreter services for pregnant women with language barriers.

Supporting disengaged children and young people living with diabetes to self-care: a qualitative study in a socially disadvantaged and ethnically diverse urban area.

OBJECTIVE: To explore how to enhance services to support the self-care of children and young people (CYP) clinically considered 'disengaged' by diabetes services. DESIGN: Qualitative study. SETTING: Two diabetes clinics in an ethnically diverse and socially disadvantaged urban area in the UK. Eligible participants were CYP living with type 1 or type 2 diabetes aged between 10 and 25 years who did not attend their last annual hospital appointment. PARTICIPANTS: 22 CYP (14 female and 8 male) aged between 10 and 19 years old took part. The sample was diverse in terms of ethnicity, age at diagnosis, family composition and presence of diabetes among other family members. DATA COLLECTION: Semistructured interviews. DATA ANALYSIS: Data were analysed thematically. RESULTS: Analysis of participant accounts confirmed the crucial importance of non-medicalised care in CYP diabetes care. A life plan was considered as important to participants as a health plan. Participants valued the holistic support provided by friends, family members and school teachers. However, they found structural barriers in their health and educational pathways as well as disparities in the quality of support at critical moments along the life course. They actively tried to maximise their well-being by balancing life priorities against diabetes priorities. Combined, these features could undermine participants engagement with health services where personal strategies were often held back or edited out of clinical appointments in fear of condemnation. CONCLUSION: We demonstrate why diabetes health teams need to appreciate the conflicting pressures experienced by CYP and to coproduce more nuanced health plans for addressing their concerns regarding identity and risk taking behaviours in the context of their life-worlds. Exploring these issues and identifying ways to better support CYP to address them more proactively should reduce disengagement and set realistic health outcomes that make best use of medical resources.

Project20: Does continuity of care and community-based antenatal care improve maternal and neonatal birth outcomes for women with social risk factors? A prospective, observational study.

BACKGROUND: Social factors associated with poor childbirth outcomes and experiences of maternity care include minority ethnicity, poverty, young motherhood, homelessness, difficulty speaking or understanding English, migrant or refugee status, domestic violence, mental illness and substance abuse. It is not known what specific aspects of maternity care work to improve the maternal and neonatal outcomes for these under-served, complex populations. METHODS: This study aimed to compare maternal and neonatal clinical birth outcomes for women with social risk factors accessing different models of maternity care. Quantitative data on pregnancy and birth outcome measures for 1000 women accessing standard care, group practice and specialist models of care at two large, inner-city maternity services were prospectively collected and analysed using multinominal regression. The level of continuity of care and place of antenatal care were used as independent variables to explore these potentially influential aspects of care. Outcomes adjusted for women's social and medical risk factors and the service attended. RESULTS: Women who received standard maternity care were significantly less likely to use water for pain relief in labour (RR 0.11, CI 0.02-0.62) and have skin to skin contact with their baby shortly after birth (RR 0.34, CI 0.14-0.80) compared to the specialist model of care. Antenatal care based in the hospital setting was associated with a significant increase in preterm birth (RR 2.38, CI 1.32-4.27) and low birth weight (RR 2.31, CI 1.24-4.32), and a decrease in induction of labour (RR 0.65, CI 0.45-0.95) compared to community-based antenatal care, this was despite women's medical risk factors. A subgroup analysis found that preterm birth was increased further for women with the highest level of social risk accessing hospital-based antenatal care (RR 3.11, CI1.49-6.50), demonstrating the protective nature of community-based antenatal care. CONCLUSIONS: This research highlights how community-based antenatal care, with a focus on continuity of carer reduced health inequalities and improved maternal and neonatal clinical outcomes for women with social risk factors. The findings support the current policy drive to increase continuity of midwife-led care, whilst adding that community-based care may further improve outcomes for women at increased risk of health inequalities. The relationship between community-based models of care and neonatal outcomes require further testing in future research. The identification of specific mechanisms such as help-seeking and reduced anxiety, to explain these findings are explored in a wider evaluation.

Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations.

BACKGROUND: Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. METHODS: The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a 'healthy baby' composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born "healthy" in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional 'healthy and positive birth' of the intervention with standard care. Qualitative data will be analysed thematically. DISCUSSION: This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. TRIAL REGISTRATION: Trial registration; ISRCTN, ISRCTN91977441 . Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

Rib Variation at Multiple Locations and Implications for Histological Age Estimation.

Existing histological age estimation methods using the rib were developed mainly from the midshaft; however, in forensic practice, uncertainty of sampling location often arises due to fragmented or previously sampled ribs. The potential for error increases when sampling location is uncertain and utilizing a section beyond the midshaft (either anterior or posterior) may result in erroneous age estimates. Additionally, there is debate within the field regarding the minimum number of sections needed for accurate age estimation. The aim of this research is to determine the importance of the midshaft distinction for age-at-death assessment and the necessity of analyzing serial sections by evaluating histological variables at sampling locations along the length of the rib. Three seriated histological sections at three sampling locations (anterior, midshaft, and posterior) were obtained from sixth ribs of ten postmortem human subjects. Cortical area (Ct.Ar) and osteon population density (OPD) were collected from each section (n = 90). Significant differences were determined in Ct.Ar between sampling locations, demonstrating the variation present along the length of the rib. A comparison of OPD at sampling locations revealed significant differences, suggesting that sampling site is critical to accurate age estimates. When sampling location is uncertain, a more anterior section should be taken. Analysis of serial sections within locations revealed no significant differences in OPD or Ct.Ar, supporting the practice of collecting data from one section for age estimation. While an age estimate can be achieved through the analysis of one section, best practice suggests reading two sections to capture intraindividual variation.

Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial­Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).

INTRODUCTION: Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial. METHODS AND ANALYSIS: Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs. ETHICS AND DISSEMINATION: The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms. TRIAL REGISTRATION NUMBER: ISRCTN20930880.

Project 20: Midwives' insight into continuity of care models for women with social risk factors: what works, for whom, in what circumstances, and how.

INTRODUCTION: Continuity of care models are known to improve clinical outcomes for women and their babies, but it is not understood how. A realist synthesis of how women with social risk factors experience UK maternity care reported mechanisms thought to improve clinical outcomes and experiences. As part of a broader programme of work to test those theories and fill gaps in the literature base we conducted focus groups with midwives working within continuity of care models of care for women with social factors that put them at a higher chance of having poor birth outcomes. These risk factors can include poverty and social isolation, asylum or refugee status, domestic abuse, mental illness, learning difficulties, and substance abuse problems. OBJECTIVE: To explore the insights of midwives working in continuity models of care for women with social risk factors in order to understand the resources they provide, and how the model of care can improve women's outcomes. DESIGN: Realist methodology was used to gain a deeper understanding of how women react to specific resources that the models of care offer and how these resources are thought to lead to particular outcomes for women. Twelve midwives participated, six from a continuity of care model implemented in a community setting serving an area of deprivation in London, and six from a continuity of care model for women with social risk factors, based within a large teaching hospital in London. FINDINGS: Three main themes were identified: 'Perceptions of the model of care, 'Tailoring the service to meet women's needs', 'Going above and beyond'. Each theme is broken down into three subthemes to reveal specific resources or mechanisms which midwives felt might have an impact on women's outcomes, and how women with different social risk factors respond to these mechanisms. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: Overall the midwives in both models of care felt the service was beneficial to women and had a positive impact on their outcomes. It was thought the trusting relationships they had built with women enabled midwives to guide women through a fragmented, unfamiliar system and respond to their individual physical, emotional, and social needs, whilst ensuring follow-up of appointments and test results. Midwives felt that for these women the impact of a trusting relationship affected how much information women disclosed, allowing for enhanced, needs led, holistic care. Interesting mechanisms were identified when discussing women who had social care involvement with midwives revealing techniques they used to advocate for women and help them to regain trust in the system and demonstrate their parenting abilities. Differences in how each team provided care and its impact on women's outcomes were considered with the midwives in the community-based model reporting how their location enabled them to help women integrate into their local community and make use of specialist services. The study demonstrates the complexity of these models of care, with midwives using innovative and compassionate ways of working to meet the multifaceted needs of this population.

The long-term health and wellbeing impacts of Healthy New Towns (HNTs): protocol for a baseline and feasibility study of HNT demonstrator sites in England.

BACKGROUND: Increasing levels of non-communicable diseases (NCDs), mental health problems, high rates of unhealthy behaviours and health inequalities remain major public health challenges worldwide. In the context of increasing urbanisation, there is an urgent need to understand how evidence that living environments shape health, wellbeing and behaviour can be used to design and deliver healthy environments in local urban settings. The Healthy New Town (HNT) programme implemented in England from 2015 consists of ten major housing developments that aim to improve population health through healthy design principles, new models for integrating health and social care and the creation of strong and connected communities. The programme provides a natural experiment in which to investigate the effects on health, wellbeing and inequalities of large-scale interventions targeting the wider social determinants of health. METHODS: The research described in this protocol aims to examine the feasibility of a larger study to assess the longer-term health impacts of HNTs, by addressing two research questions: (1) what are the similarities and differences in the HNT programme developments, processes, contexts and expected impacts and outcomes across HNT sites? and (2) how feasible is the use of data from routine sources and existing HNT evaluations and as the baseline for a definitive study to assess impact on health, wellbeing, behavioural and economic outcomes and programme processes? The research will consist of (a) participatory systems mapping with stakeholders to produce a theoretical framework for a longer-term study on the HNT programme, (b) synthesis of existing qualitative data from local HNT evaluations to understand local processes and intervention mechanisms, (c) scoping local and routinely available data to establish a baseline and feasibility for a longer-term study of health and economic outcomes, and (d) building relationships and recruiting HNT sites into the proposed research. DISCUSSION: The proposed research will produce a theoretical framework and assess the feasibility of a definitive study of outcomes of the HNT programme. This research is necessary to understand how longer-term health, wellbeing, behavioural and economic outcomes can be measured, and to inform a definitive study to generate evidence on the effectiveness of the HNT programme.

Virtual group consultations offer continuity of care globally during Covid-19.

Covid-19 has led to virtual care (mainly telephone consultations) becoming a default worldwide, despite well-documented shortcomings. Published evidence on virtual group consultations is limited, although interest and front-line experience have grown substantially since pandemic onset. Unpublished data are summarised showing feasibility of transitioning care to this model across different countries, care settings and conditions. An international webinar series has supported development and sharing of best practice and representative data on spread and utilisation of virtual groups. This model of care creates time and space for more questions and answers, so once engaged patients become staunch advocates. Group care supports personalised care and lifestyle medicine, which is growing very rapidly. In the current context, even healthcare providers under pressure can implement virtual group consultations. Most virtual group consultations have a facilitator, so this allows roles to be extended and support education of both students and new team members. These can confer greater access, continuity of care, peer support and timely information about Covid-19 and may result in better health outcomes. Given the rapid and widespread implementation of virtual care during this pandemic, data should be shared effectively and methodologically sound observational studies and clinical trials to test safety and effectiveness should be promoted now.

How do women with social risk factors experience United Kingdom maternity care? A realist synthesis.

BACKGROUND: Echoing international trends, the most recent United Kingdom reports of infant and maternal mortality found that pregnancies to women with social risk factors are over 50% more likely to end in stillbirth or neonatal death and carry an increased risk of premature birth and maternal death. The aim of this realist synthesis was to uncover the mechanisms that affect women's experiences of maternity care. METHODS: Using realist methodology, 22 papers exploring how women with a wide range of social risk factors experience maternity care in the United Kingdom were included. The data extraction process identified contexts (C), mechanisms (M), and outcomes (0). RESULTS: Three themes, Resources, Relationships, and Candidacy, overarched eight CMO configurations. Access to services, appropriate education, interpreters, practical support, and continuity of care were particularly relevant for women who are unfamiliar with the United Kingdom system and those living chaotic lives. For women with experience of trauma, or those who lack a sense of control, a trusting relationship with a health care professional was key to regaining trust. Many women who have social care involvement during their pregnancy perceive health care services as a system of surveillance rather than support, impacting on their engagement. This, as well as experiences of paternalistic care and discrimination, could be mitigated through the ability to develop trusting relationships. CONCLUSIONS: The findings provide underlying theory and practical guidance on how to develop safe services that aim to reduce inequalities in women's experiences and birth outcomes.

Better together: A qualitative exploration of women's perceptions and experiences of group antenatal care.

PROBLEM: Childbearing women from socio-economically disadvantaged communities and minority ethnic groups are less likely to access antenatal care and experience more adverse pregnancy outcomes. BACKGROUND: Group antenatal care aims to facilitate information sharing and social support. It is associated with higher rates of attendance and improved health outcomes. AIMS: To assess the acceptability of a bespoke model of group antenatal care (Pregnancy Circles) in an inner city community in England, understand how the model affects women's experiences of pregnancy and antenatal care, and inform further development and testing of the model. METHODS: A two-stage qualitative study comprising focus groups with twenty six local women, followed by the implementation of four Pregnancy Circles attended by twenty four women, which were evaluated using observations, focus groups and semi-structured interviews with participants. Data were analysed thematically. FINDINGS: Pregnancy Circles offered an appealing alternative to standard antenatal care and functioned as an instrument of empowerment, mediated through increased learning and knowledge sharing, active participation in care and peer and professional relationship building. Multiparous women and women from diverse cultures sharing their experiences during Circle sessions was particularly valued. Participants had mixed views about including partners in the sessions. CONCLUSIONS: Group antenatal care, in the form of Pregnancy Circles, is acceptable to women and appears to enhance their experiences of pregnancy. Further work needs to be done both to test the findings in larger, quantitative studies and to find a model of care that is acceptable to women and their partners.