What are the mechanisms of effect of group antenatal care? A systematic realist review and synthesis of the literature.

BACKGROUND: There is growing interest in the benefits of group models of antenatal care. Although clinical reviews exist, there have been few reviews that focus on the mechanisms of effect of this model. METHODS: We conducted a realist review using a systematic approach incorporating all data types (including non-research and audiovisual media), with synthesis along Context-Intervention-Mechanism-Outcome (CIMO) configurations. RESULTS: A wide range of sources were identified, yielding 100 relevant sources in total (89 written and 11 audiovisual). Overall, there was no clear pattern of 'what works for whom, in what circumstances' although some studies have identified clinical benefits for those with more vulnerability or who are typically underserved by standard care. Findings revealed six interlinking mechanisms, including: social support, peer learning, active participation in health, health education and satisfaction or engagement with care. A further, relatively under-developed theory related to impact on professional practice. An overarching mechanism of empowerment featured across most studies but there was variation in how this was collectively or individually conceptualised and applied. CONCLUSIONS: Mechanisms of effect are amplified in contexts where inequalities in access and delivery of care exist, but poor reporting of populations and contexts limited fuller exploration. We recommend future studies provide detailed descriptions of the population groups involved and that they give full consideration to theoretical underpinnings and contextual factors. REGISTRATION: The protocol for this realist review was registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42016036768).

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).

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.

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.

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.

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.

Consulting with young people to inform systematic reviews: an example from a review on the effects of schools on health.

BACKGROUND: There has been increasing interest in involving the public in systematic reviews as they provide a shortcut to the evidence and arguably have greater influence over policy decisions and ultimately people's lives. Case examples of this involvement are rare, especially for reviews focused on children and young people. This study describes the process and impact of consulting with a young people's advisory group to inform decision making in a systematic review on the effects of schools and school environment interventions on children and young people's health. METHODS: Consultations were conducted with a pre-existing group of young people brought together to advise on public health research. Their views were sought at two key stages: (i) at the beginning when general views relating to the policy problem under study were elicited; and (ii) half-way through to advise on how to focus the review on key priorities. RESULTS: Young people's involvement in our review ensured that the scope of our review was appropriate and that issues which were important to young people were considered. The group was especially valuable in terms of prioritizing in a relevant and meaningful way. A crucial additional impact of involvement was young people providing 'early signals' of key themes for the synthesis.

The social ecology of girls' bullying practices: exploratory research in two London schools.

This exploratory study adopts a socio-ecological approach to examine the context of school bullying. It asks: (1) what are students' accounts of bullying practices?; (2) how are these enabled and constrained by the school-environment?; (3) how is gender implicated? Qualitative data were collected from girls in two schools in London via focus groups (one in each school; students aged 12-15) and seven semi-structured interviews (in one school; students aged 16-18); and from school policy documents. Our interpretation of girls' accounts, informed by Giddens' structuration theory, suggests that bullying practices were spatially patterned in the schools and often characterised by the regulation of girls' sexuality and sexual-harassment. Repeated acts of aggression were fluid with regard to the bully and victim role, challenging the dominant view of bullying as characterised by consistent disparities in power between individuals. Schools structured bullying behaviour via policies and practices that ignored these forms of abuse and which focused on and may have been complicit in the making of stable 'bully' and 'victim' roles, thus indirectly contributing to the reproduction of unhealthy relationships between students. In terms of gender, traditional gendered and sexual discourses appear to structure the identities of the schools and girls in our study.

Involving women with limited English proficiency in group antenatal care: Findings from the integrated process evaluation of the Pregnancy Circles pilot trial.

Problem In the United Kingdom, poor experiences and outcomes of antenatal care among women with limited English proficiency (LEP) are widely documented. BACKGROUND: Group antenatal care aims to address some limitations of traditional care by combining health assessment, information sharing and peer support, but the inclusion of women with LEP in mixed-language groups has not been explored. AIM: This qualitative study used observations and interviews to explore whether linguistic diversity could be incorporated into group antenatal care (Pregnancy Circles). Women with LEP were invited to take part in mixed-language groups in a large urban NHS trust as part of the Pregnancy Circles pilot trial (ISRCTN66925258 Retrospectively registered 03 April 2017; North of Scotland Research Ethics Service 16/NS/0090). FINDINGS: Three Pregnancy Circles including women with LEP were implemented. Linguistically integrated groups required additional resources (time, interpreters, midwifery skills). Four themes emerged: 'Interpreting as helping', 'Enhanced learning', 'Satisfaction and belonging' and 'Complex lives'. DISCUSSION: Women with LEP accessing interpreting in Pregnancy Circles reported high levels of satisfaction, contrasting with reported experiences in traditional care. Three theories of effect emerged as relevant for women with LEP: social support.

Predictors of the timing of initiation of antenatal care in an ethnically diverse urban cohort in the UK.

BACKGROUND: In the UK, women are recommended to engage with maternity services and establish a plan of care prior to the 12th completed week of pregnancy. The aim of this study was to identify predictors for late initiation of antenatal care within an ethnically diverse cohort in East London. METHODS: Cross-sectional analysis of routinely collected electronic patient record data from Newham University Hospital NHS Trust (NUHT). All women who attended their antenatal booking appointment within NUHT between 1st January 2008 and 24th January 2011 were included in this study. The main outcome measure was late antenatal booking, defined as attendance at the antenatal booking appointment after 12 weeks (+6 days) gestation. Data were analysed using multivariable logistic regression with robust standard errors. RESULTS: Late initiation of antenatal care was independently associated with non-British (White) ethnicity, inability to speak English, and non-UK maternal birthplace in the multivariable model. However, among those women who both spoke English and were born in the UK, the only ethnic group at increased risk of late booking were women who identified as African/Caribbean (aOR: 1.40: 95% CI: 1.11, 1.76) relative to British (White). Other predictors identified include maternal age younger than 20 years (aOR: 1.32; 95% CI: 1.13-1.54), high parity (aOR: 2.09; 95% CI: 1.77-2.46) and living in temporary accommodation (aOR: 1.71; 95% CI: 1.35-2.16). CONCLUSIONS: Socio-cultural factors in addition to poor English ability or assimilation may play an important role in determining early initiation of antenatal care. Future research should focus on effective interventions to encourage and enable these minority groups to engage with the maternity services.

The school environment and student health: a systematic review and meta-ethnography of qualitative research.

BACKGROUND: There is increasing interest in promoting young people's health by modifying the school environment. However, existing research offers little guidance on how the school context enables or constrains students' health behaviours, or how students' backgrounds relate to these processes. For these reasons, this paper reports on a meta-ethnography of qualitative studies examining: through what processes does the school environment (social and physical) influence young people's health? METHODS: Systematic review of qualitative studies. Sixteen databases were searched, eliciting 62,329 references which were screened, with included studies quality assessed, data extracted and synthesized using an adaptation of Noblit and Hare's meta-ethnographic approach. RESULTS: Nineteen qualitative studies were synthesised to explore processes through which school-level influences on young people's health might occur. Four over-arching meta-themes emerged across studies focused on a range of different health issues. First, aggressive behaviour and substance use are often a strong source of status and bonding at schools where students feel educationally marginalised or unsafe. Second, health-risk behaviours are concentrated in unsupervised 'hotspots' at the school. Third, positive relationships with teachers appear to be critical in promoting student wellbeing and limiting risk behaviour; however, certain aspects of schools' organisation and education policies constrain this, increasing the likelihood that students look for a sense of identity and social support via health-risk behaviours. Fourth, unhappiness at school can cause students to seek sources of 'escape', either by leaving school at lunchtime or for longer unauthorized spells or through substance use. These meta-themes resonate with Markham and Aveyard's theory of human functioning and school organisation, and we draw on these qualitative data to refine and extend this theory, in particular conceptualising more fully the role of young people's agency and student-led 'systems' in constituting school environments and generating health risks. CONCLUSION: Institutional features which may shape student health behaviours such as lack of safety, poor student-staff relationships and lack of student voice are amenable to interventions and should be the subject of future investigation. Future qualitative research should focus on health behaviours which are under-theorised in this context such as physical activity, sexual and mental health.

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.

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.

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.

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.

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.

Behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19 years: a systematic review.

We systematically reviewed school-based skills building behavioural interventions for the prevention of sexually transmitted infections. References were sought from 15 electronic resources, bibliographies of systematic reviews/included studies and experts. Two authors independently extracted data and quality-assessed studies. Fifteen randomized controlled trials (RCTs), conducted in the United States, Africa or Europe, met the inclusion criteria. They were heterogeneous in terms of intervention length, content, intensity and providers. Data from 12 RCTs passed quality assessment criteria and provided evidence of positive changes in non-behavioural outcomes (e.g. knowledge and self-efficacy). Intervention effects on behavioural outcomes, such as condom use, were generally limited and did not demonstrate a negative impact (e.g. earlier sexual initiation). Beneficial effect on at least one, but never all behavioural outcomes assessed was reported by about half the studies, but this was sometimes limited to a participant subgroup. Sexual health education for young people is important as it increases knowledge upon which to make decisions about sexual behaviour. However, a number of factors may limit intervention impact on behavioural outcomes. Further research could draw on one of the more effective studies reviewed and could explore the effectiveness of 'booster' sessions as young people move from adolescence to young adulthood.

An economic model of school-based behavioral interventions to prevent sexually transmitted infections.

OBJECTIVES: Reducing sexually transmitted infections (STI) and teenage pregnancy through effective health education is a high priority for health policy. Behavioral interventions which teach skills to practice safer sex may reduce the incidence of STIs. We evaluated the cost-effectiveness of school-based behavioral interventions in young people. METHODS: We developed an economic model to estimate the total number of STI cases averted, consequent gain in health related quality of life (HRQoL) and savings in medical costs, based on changes in sexual behavior. The parameters for the model were derived from a systematic literature search on the intervention effectiveness, epidemiology of STIs, sexual behavior and lifestyles, HRQoL and health service costs. RESULTS: The costs of providing teacher-led and peer-led behavioral interventions were €5.16 and €18 per pupil, respectively. For a cohort of 1000 boys and 1000 girls aged 15 years, the model estimated that the behavioral interventions would avert two STI cases and save 0.35 Quality Adjusted Life Years (QALYs). Compared to standard education, the incremental cost-effectiveness of the teacher-led and peer-led interventions was €24,268 and €96,938 per QALY gained, respectively. CONCLUSIONS: School-based behavioral interventions which provide information and teach young people sexual health skills can bring about improvements in knowledge and increased self-efficacy, though these may be limited in terms of impact on sexual behavior. There was uncertainty around the results due to the limited effect of the intervention on behavioral outcomes and paucity of data for other input parameters.

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.