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Introduction Electronic health records are invaluable for pregnancy-related studies. The Clinical Practice Research Datalink (CPRD) Pregnancy Register (PR) identifies pregnancies in primary care records, including uncertain cases. Objectives This paper outlines a method to reduce uncertainty in identifying pregnancies within CPRD GOLD PR data, exemplified through a study investigating the provision of pre-pregnancy care. Methods We used CPRD Mother Baby Link (MBL) and Maternity Hospital Episode Statistics (HES) to clean and augment the CPRD PR data. The study included all women aged 18-48yrs, registered at an English GP practice within CPRD on 01/01/2017, with a year of prior registration and eligibility for hospital data linkage. We developed a cleaning and combining algorithm and further applied strict data quality criteria to form three populations: 'as provided', 'derived' (using our algorithm) and 'strictly derived' (with stricter data quality criteria). We compared characteristics and outcomes across these populations, examining potential biases in effect estimates using the 'as provided' population. Results Our algorithm added 22,270 (~7%) pregnancies from hospital data to the CPRD PR (1997-2021), eliminated conflicting pregnancies and pregnancies with unknown outcomes, and minimised potentially non-contemporaneous records of past pregnancies or partial records of pregnancies. For all pregnancies across women's reproductive history, in the `strictly derived' population, characterised by better data quality, a higher prevalence of pre-existing medical conditions and increased pre-pregnancy care were observed. In this dataset, recording of both exposure and outcome was better, and the magnitude of the association between exposure and outcome was reduced compared to the `as provided' population. Conclusion PR data requires cleaning before use. This study presents a pragmatic and practical method to identify pregnancies using existing CPRD data and linked records, without needing additional data. Researchers should carefully consider their studies' specific requirements and may adapt our proposed methodology accordingly to align with their research questions.

Abstract Background Obstetric Bleeding Study UK (OBS UK) (award ID: 152057) is a National Institute for Health and Care Research (NIHR)-funded stepped wedge cluster randomised controlled trial of a complex intervention for postpartum haemorrhage. This was developed in Wales and evaluated in a feasibility study, with improvements in maternal outcomes observed. Generalisability of the findings is limited by lack of control data and limited ethnic diversity in the Welsh obstetric patient population compared to the United Kingdom (UK): 94% of the Welsh population identifies as White, versus 82% in the UK. Non-White ethnicity and socioeconomic deprivation are linked to increased risk of adverse maternal outcomes. Traditionally, decisions regarding site selection are based on desire to complete trials on target in ‘tried and tested’ research active institutions. To ensure widespread applicability of the results and investigate the impact of ethnicity and social deprivation on trial outcomes, maternity units were recruited that represent the ethnic diversity and social deprivation profiles of the UK. Method Using routinely collected, publicly available data, an interactive dashboard was developed that demonstrates the demographics of the population served by each maternity unit in the UK, to inform site recruitment. Data on births per year, ethnic and socioeconomic group of the population for each maternity unit, across the UK, were integrated into the dashboard. Results The dashboard demonstrates that OBS UK trial sites reflect the ethnic and socioeconomic diversity of the UK (study vs UK population ethnicity: White 79.2% vs 81.7%, Asian 10.5% vs 9.3%, Black 4.7% vs 4.0%, Mixed 2.5% vs 2.9%, Other 3.0% vs 2.1%) with variation in site demography, size and location. Missing data varied across sites and nations and is presented. Conclusion The NIHR equality, diversity and inclusion strategy states studies must widen participation, facilitating individuals from all backgrounds to engage. The development of this novel interactive dashboard demonstrates an innovative way of achieving this. National Health Service (NHS) maternity researchers should consider using this tool to enhance diversity in research, address health disparities and improve generalisability of findings. This approach could be applied to healthcare settings beyond maternity care and across different global populations. Trial registration ISRCTN 17679951. Registered on August 30, 2023.

Abstract Background Midwifery continuity of carer (MCoC) is a model of care in which the same midwife or small team of midwives supports women throughout pregnancy, birth and the postnatal period. The model has been prioritised by policy makers in a number of high-income countries, but widespread implementation and sustainability has proved challenging. Methods In this narrative review and synthesis of the global literature on the implementation and sustainability of midwifery continuity of carer, we identify barriers to, and facilitators of, this model of delivering maternity care. By mapping existing research evidence onto the Consolidated Framework for Implementation Research (CFIR), we identify factors for organisations to consider when planning and implementing midwifery continuity of carer as well as gaps in the current research evidence. Results Analysing international evidence using the CFIR shows that evidence around midwifery continuity of carer implementation is patchy and fragmented, and that the impetus for change is not critically examined. Existing literature pays insufficient attention to core aspects of the innovation such as the centrality of on call working arrangements and alignment with the professional values of midwifery. There is also limited attention to the political and structural contexts into which midwifery continuity of carer is introduced. Conclusions By synthesizing international research evidence with the CFIR, we identify factors for organisations to consider when planning and implementing midwifery continuity of carer. We also call for more systematic and contextual evidence to aid understanding of the implementation or non-implementation of midwifery continuity of carer. Existing evidence should be critically evaluated and used more cautiously in support of claims about the model of care and its implementation, especially when implementation is occurring in different settings and contexts to the research being cited.

Background Around one in three pregnant women undergoes induction of labour in the United Kingdom, usually preceded by in-hospital cervical ripening to soften and open the cervix. Objectives This study set out to determine whether cervical ripening at home is within an acceptable safety margin of cervical ripening in hospital, is effective, acceptable and cost-effective from both National Health Service and service user perspectives. Design The CHOICE study comprised a prospective multicentre observational cohort study using routinely collected data (CHOICE cohort), a process evaluation comprising a survey and nested case studies (qCHOICE) and a cost-effectiveness analysis. The CHOICE cohort set out to compare outcomes of cervical ripening using dinoprostone (a prostaglandin) at home with in-hospital cervical ripening from 39 weeks of gestation. Electronic maternity record data were collected from 26 maternity units. Following pilot analysis, the primary comparison was changed to ensure feasibility and to reflect current practice, comparing home cervical ripening using a balloon catheter with in-hospital cervical ripening using any prostaglandin from 37 weeks of gestation. Analysis involved multiple logistic regression for the primary outcome and descriptive statistics for all other outcomes. The qCHOICE study reported descriptive statistics of quantitative survey data and thematic analysis of focus group and interview data. The economic analysis involved a decision-analytic model from a National Health Service and Personal Social Services perspective, populated with CHOICE cohort and published data. Secondary analysis explored the patient perspective utilising cost estimates from qCHOICE data. Setting Twenty-six United Kingdom maternity units. Participants Women with singleton pregnancies at or beyond 37 weeks of gestation having induction with details of cervical ripening method and location recorded. Main outcome measures CHOICE cohort Neonatal unit admission within 48 hours of birth for 48 hours or more. qCHOICE Maternal and staff experience of cervical ripening. Economic analysis Incremental cost per neonatal unit admission within 48 hours of birth avoided. Data sources Electronic maternity records from 26 maternity units; survey and interviews with service users/maternity staff; focus groups with maternity staff; published literature on economic aspects. Results CHOICE cohort: A total of 515 women underwent balloon cervical ripening at home and 4332 underwent in-hospital cervical ripening using prostaglandin in hospitals that did not offer home cervical ripening. Neonatal unit admission within 48 hours of birth for 48 hours or more following home cervical ripening with balloon was not increased compared with in-hospital cervical ripening with prostaglandin. However, there was substantial uncertainty with the adjusted analysis consistent with a 74% decrease in the risk through to an 81% increase. qCHOICE Important aspects of service users’ experience of home cervical ripening were quality of information provided, support and perception of genuine choice. Economic analysis Home cervical ripening with balloon led to cost savings of £993 (−£1198, −£783) per woman and can be considered the dominant strategy. Limitations Circumstances relating to the COVID-19 pandemic limited the number of participating maternity units and the duration for which units participated. Low numbers of women having at-home cervical ripening limited the power to detect differences in safety, effectiveness, cost and acceptability between study groups. Conclusions Home cervical ripening using balloon catheter may be as safe for babies as using prostaglandins in hospital in low and moderate-risk groups, but there is substantial uncertainty. Home cervical ripening with balloon is likely to be cost saving. Impacts on workload, service user and staff experiences were complex. Future work Future research should focus on optimising experience and logistics of home cervical ripening within busy maternity services. Study registration Current Controlled Trials ISRCTN32652461. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127569) and is published in full in Health Technology Assessment; Vol. 28, No. 81. See the NIHR Funding and Awards website for further award information. Plain language summary Labour is often started artificially. This is called induction of labour. Induction of labour is usually planned when it is safer to end the pregnancy. The first stage of induction of labour – ‘cervical ripening’ – means using medication or a balloon to open the neck of the womb. Years ago, cervical ripening only happened in hospitals, but now many women are offered ‘home cervical ripening’. This means that induction of labour starts in hospital then women go home while the treatment starts working. This could mean that women spend less time in hospital. They may prefer to be at home. However, home cervical ripening may be less safe because problems may not be noticed as quickly. We looked at whether home cervical ripening is safe, acceptable to women and their partners, and good value for money. We used information about women and babies that is usually stored in electronic maternity notes. We studied women who had induction of labour in 26 United Kingdom maternity hospitals. Women were told about the study and could choose not to be included. Our main question was ‘does home cervical ripening increase the chance that a baby needs care in a neonatal unit, compared with cervical ripening in hospital?’ We surveyed women about their experience of induction of labour and any financial costs to them. We interviewed women, partners, doctors and midwives to hear what they thought about home cervical ripening. Fewer women than expected had home cervical ripening. We could not be certain that home cervical ripening with a balloon is as safe for babies as cervical ripening in hospital using medication. Home cervical ripening cost almost £1000 less per woman than in-hospital cervical ripening. Home cervical ripening was acceptable to women when they felt well looked after, when maternity staff communicated well with them, and when they felt they had a choice about going home. Scientific summary Background Around one in three pregnant women in the UK undergo induction of labour (IOL). The first step often involves cervical ripening (opening and shortening the cervix). Cervical ripening may be undertaken using either balloon catheters or administration of prostaglandin. Cervical ripening at home may reduce hospital stay during IOL and may be more acceptable to women than in-hospital cervical ripening. It is unclear whether it may increase risks to the unborn baby due to less monitoring of their well-being during the IOL process and whether it is acceptable to women and partners. It is also unclear whether home cervical ripening is cost-effective. Objective To assess whether it is safe, effective, cost-effective and acceptable to service users and providers to carry out home cervical ripening during IOL, the research questions asked were: Is home cervical ripening within an acceptable margin of in-hospital cervical ripening for safety, cost and acceptability outcomes? Is a strategy of home cervical ripening using a balloon as safe as in-hospital cervical ripening using prostaglandin for the primary outcome of neonatal unit (NINU) admission within 48 hours of birth for 48 hours or more? Is home cervical ripening as acceptable to service-users and health professionals as in-hospital cervical ripening? Are NHS and service user costs of home cervical ripening using a balloon comparable to costs of in-hospital cervical ripening using prostaglandin? Methods This project incorporated a prospective multicentre observational cohort study using real-world data from hospital electronic health records, a survey of service users and nested case studies involving interviews and focus groups, evaluating process and service user and provider experiences, and a health economic analysis. The original design was a comparison of home versus in-hospital cervical ripening using a non-inferiority design to determine whether home cervical ripening is within an acceptable margin (+ 4%) of in-hospital cervical ripening for the safety outcome of NNU admission, whether it is more acceptable to women and whether it is cost-effective. As insufficient home cervical ripening cases were identified at the pilot analysis stage, the statistical analysis was modified to a simple logistic regression on the primary outcome (NNU admission within 48 hours for 48 hours or more), unadjusted and adjusted by potential confounders. This was done because the limited sample size of the primary exposure variable (home vs. hospital) did not have enough power to answer the non-inferiority question as proposed. This had a knock-on effect on the other aspects of the project as well. Observational cohort A total of 26 maternity units in the UK contributed data to the observational cohort study, of whom 8 offered balloon home cervical ripening and 18 offered only in-hospital cervical ripening using prostaglandin. The sample included geographically and socially diverse populations. All units used the BadgerNet Maternity Notes (System C, Stratford-upon-Avon, UK) information system to record routine maternity care information. Deidentified data on all eligible women having IOL was extracted from the BadgerNet system using existing data fields. Data were securely transferred to the University of Edinburgh. Data were analysed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA). We used mixed-effects logistic regression for the comparison of NNU admission within 48 hours to control for treatment indication bias, with hospital/trust as a random effect. Further outcomes were reported descriptively as medians and interquartile ranges, proportions and percentages. Process evaluation A process evaluation was undertaken to identify contextual influences on implementation of cervical ripening protocols and outcomes and assess the acceptability of home cervical ripening and the experiences of women and their birth partners, professionals and other key stakeholders. The process evaluation comprised an online postnatal survey, five case study sites and qualitative interviews and focus groups with service users and staff. Overall, 309 women returned completed surveys. In the case study sites, interviews were undertaken with women (n = 43), partners (n = 17) and health professionals (n = 48) and four focus groups were conducted with health professionals (n = 28). Because the COVID-19 pandemic occurred during the study period, which had wide-reaching effects on maternity care, an additional survey of healthcare professionals at all UK NHS trusts and boards was conducted to determine whether aspects of practice and policy around IOL had altered in response to the pandemic. In total, surveys were returned from 92 of the UK NHS trusts and boards offering maternity services across the UK. Survey data were reported using descriptive statistics and qualitative data were analysed using a thematic framework. The original design involved audio recording of a sample of consultations where IOL is discussed to assess women’s involvement in the decision-making processes (analysed using the OPTION scale); however, COVID-19-related restrictions precluded this element. Health economic analysis An economic analysis was undertaken from the perspective of the NHS and Personal Social Services using a decision tree model, populated with data from the CHOICE study. Resource use data were combined with unit costs to calculate the within study cost for each strategy and outcomes were reported in terms of incremental cost per NNU admission avoided. A secondary analysis considered the patient perspective, including costs incurred by women and their families relating to IOL, gathered from the qCHOICE survey responses. Data sources Electronic patient records from 26 study sites (extracted via the BadgerNet maternity records data system): observational cohort study; economic analysis. Qualitative interviews and focus groups: process evaluation. Postnatal survey: process evaluation; economic analysis. Published literature: economic analysis. Results Observational cohort study The unanticipated context of the CHOICE study was an NHS under pressure to manage high IOL rates (range 31–49%) and long delays throughout the IOL process during the COVID-19 pandemic. Home cervical ripening using balloon was performed in women for a wide array of indications (low to moderate risk groups) and from 37 weeks of gestation. The main analysis population consisted of 17,350 women with singleton pregnancies having IOL at 37 weeks or later, of whom 515 underwent home cervical ripening using balloon, 4332 underwent in-hospital cervical ripening with prostaglandin in hospitals that only offered in-hospital cervical ripening, and 7397 women underwent in-hospital cervical ripening with prostaglandin in a hospital that also offered home cervical ripening. Compared with in-hospital cervical ripening with prostaglandin, the rate of NNU admission within 48 hours of birth for 48 hours or more following home cervical ripening with balloon was not increased. The event rate for this primary outcome was expected to be 6% for the in-hospital group. The rate was much lower than expected in both arms (3.1% after home cervical ripening vs. 4.8% after in-hospital cervical ripening) and there was no statistically significant difference between groups before or after adjusting for potential confounding variables. However, the odds ratio of 0.75 has a wide 95% confidence interval (CI) of 0.35 to 1.64 (0.81; 95% CI 0.36 to 1.81 in the adjusted analysis) signalling substantial uncertainty in this finding. Process evaluation Eligibility criteria for those offered the option of home cervical ripening varied between sites. Care was often planned around capacity rather than in line with guidance/policy. Of 230 survey respondents who underwent to in-hospital cervical ripening, the mean stay prior to transfer to labour ward was 31.5 hours (range 0–260 hours). Women reported physically and emotionally unsafe situations caused by these delays. Impact of COVID-19 Of responding sites, 23% reported a change in the method used for cervical ripening and 28% reported a change in criteria for offering home cervical ripening. Only 7% and 6%, respectively, reported changes in the professionals undertaking cervical ripening or the approach for post-dates IOL. The majority of respondents stated that there was no change (61%) or that more women (28%) were discharged home after cervical ripening. There was little consistency in policy changes during the pandemic – one study site expanded home cervical ripening eligibility while another completely suspended it. Acceptability to service users While attitudes towards home cervical ripening were positive, the experiences of those who actually went home were mixed. The positive experiences were most often associated with being in the comfort of one’s own environment. Safety appeared to be the biggest concern for those who said they would not want to return home for cervical ripening. Crucially, women and birth partners wanted the choice to go home or stay in hospital and lack of choice was evident both in survey responses and in case study site interviews. Women who had home cervical ripening were more likely to choose that option again (64%) and recommend it to others (61%) than those who stayed in hospital (55%, 54%). Women who had a balloon catheter inserted reported more discomfort than those who had a prostaglandin pessary or osmotic dilator, although ability to cope with discomfort was similar across all cervical ripening methods. Attentive care and access to pain relief were important to women and birth partners. Acceptability to clinicians and health professionals Attitudes were generally positive, and many healthcare professionals perceived mechanical methods to be the safest for home cervical ripening. Home cervical ripening was often seen as a potential solution to workload and capacity issues, but several professionals highlighted that it was not necessarily straightforward and that there could be unintended consequences for workload, including the management of re-admissions. Information Half of survey respondents did not feel they had enough information about what to expect during IOL, and over half (57%) felt that they had either had no choice or no alternative when deciding to have IOL. Psychological correlates Forty-one survey respondents described their experience of IOL as difficult or traumatic. Some maternity professionals also reported moral distress in relation to the process. Factors mediating experience The principal factors mediating experience of IOL were support from healthcare professionals, the presence of birth partners, information provision and having choice, privacy and having their own space, and delays. In the survey, the most important factor in a positive experience was support from kind, caring staff and feeling safe. Barriers and enablers of adoption Staff shortages was one of the key barriers to adoption of home cervical ripening. Delays during IOL were linked to unit capacity, staffing and workload. Enablers included cross-boundary collaboration, cross-trust/board knowledge sharing, consistent training and professional confidence. Health economic analysis The economic model found that home cervical ripening with balloon led to cost savings of £993 (−£1198, −£783) per woman, with no difference in NNU admissions avoided (mean 0.005; 95% CI −0.05 to 0.013). At willingness-to-pay thresholds above £3000, there is an 82% probability that home cervical ripening with balloon is the optimal option and in economic terms would be considered the dominant strategy compared with in-hospital cervical ripening with prostaglandin. Probabilistic sensitivity analysis indicates little uncertainty regarding the cost savings, however there was uncertainty regarding the impact on NNU admission. Any potential increase in NNU admissions between arms would be negligible. The cost savings in the home cervical ripening group are driven primarily by reduced time in an antenatal ward for the home cervical ripening group, with an average of 476 minutes (7.9 hours) compared with 2243 minutes (37.4 hours) in the in-hospital group. The resource use and cost data also indicate some of the ‘hidden’ or displaced costs of the home cervical ripening option, with an increased number and duration of phone calls from women and their partners to the hospital compared with those in the in-hospital group. Economic analysis of ‘spill over’ costs found that the average transport cost was higher among the mothers who had hospital cervical ripening (£23.10) than mothers who had home cervical ripening (£18.74). The total patient perspective cost was higher in the hospital arm (£954) compared with the home arm (£665), which was predominantly driven by the opportunity cost of partners’/other caregivers’ time supporting the mother either at home or in hospital ‘away from other activities’. Conclusions The CHOICE study provided multiple perspectives on the difference between home cervical ripening with balloon and in-hospital cervical ripening with prostaglandin during IOL, within a context of high IOL rates and multiple delays in the process. Home cervical ripening with balloon appears both safe and cost-effective when compared with in-hospital cervical ripening with prostaglandin for a range of indications, although safety conclusions are uncertain. Acceptance of home cervical ripening depends upon high-quality informed decision-making and consistent support for women throughout the IOL process, a reality that was often lacking in the study participants’ experience. Future research should focus on: Further exploration and implementation of system features that lead to positive experiences of home cervical ripening. Measuring rare but important safety outcomes of home cervical ripening. Practice implications of the CHOICE findings are that units should consider the practicalities of offering genuine choice around setting for IOL and ensure adequate staffing and support for women throughout their IOL experience regardless of setting for cervical ripening. Unless women feel supported to choose between home and in-hospital settings, and they have sufficient information to allow realistic expectations of the IOL process, women will not have positive birth experiences. Study registration Current Controlled Trials ISRCTN32652461. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127569) and is published in full in Health Technology Assessment; Vol. 28, No. 81. See the NIHR Funding and Awards website for further award information.

Abstract Background Perineal trauma, involving either naturally occurring tears or episiotomy, is common during childbirth but little is known about its psychological impact. This study aimed to determine the associations between childbirth related perineal trauma and psychological outcomes reported by women three months after giving birth and to explore factors that could mediate relationships between perineal trauma and maternal psychological outcomes. Methods This study was a secondary analysis of data from a cross-sectional population-based survey of maternal and infant health. A total of 4,578 women responded to the survey, of which 3,307 had a vaginal birth and were eligible for inclusion into the analysis. Symptoms of depression, anxiety, and post-traumatic stress (PTS) symptoms were assessed using validated self- report measures. Physical symptoms were derived from a checklist and combined to produce a composite physical symptoms score. Regression models were fitted to explore the associations. Results Nearly three quarters of women experienced some degree of perineal trauma. Women who experienced perineal trauma reported having more postnatal physical symptoms (adjusted proportional odds ratio 1.47, 95%CI 1.38 to 1.57, p-value

BackgroundSystematic review evidence suggests preconception health interventions may be effective in improving a range of outcomes. However, few studies have explored women’s views on potential content and delivery methods for these interventions.MethodsParticipants were purposively sampled from respondents (n = 313) of a survey. Semi-structured, in-depth interviews were conducted to explore their views on seven candidate delivery methods for preconception health interventions: general practitioners (GPs), nurse practitioners, pharmacists, social media, personal texts and emails, pregnancy tests, and health education in schools. Data were analyzed using a data-driven framework analysis.ResultsTwenty women were interviewed. Women wanted interventions to be easily accessible but allow them to conceal their pregnancy plans. They preferred to choose to receive preconception interventions but were receptive to health professionals raising preconception health during ‘relevant’ appointments such as contraceptive counseling and cervical smear tests. They wanted intervention content to provide trustworthy and positively framed information that highlights the benefits of good preconception health and avoids stigmatizing women for their weight and preconception actions. The inclusion of support for preconception mental health and the use of visual media, personalization, simple information, and interesting and unfamiliar facts were viewed favorably.ConclusionInterventions to improve preconception health should reflect the sensitivities of pregnancy intentions, be easy to access in a way that enables discretion, and be designed to seek consent to receive the intervention. These interventions should ideally be tailored to their target populations and provide trustworthy information from reputable sources. The potential for unintended harmful effects should be explored.

Introduction Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.Methods and analysis A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become ‘infant feeding helpers’ in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.Ethics and dissemination The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.Trial registration number ISRCTN17395671.

Introduction It is well documented that many women do not desire a short interpregnancy interval. Medical societies, government agencies and leaders in the field recommend that contraception should be part of maternity care. Short spaced and unplanned pregnancies increase the chances of mortality and morbidity in the mother and child. The WHO recommends a 24-month interpregnancy interval; however, short pregnancy intervals remain common. The goal of this scoping review will be to explore barriers and facilitators to the uptake of early postnatal contraception. A review of globally published literature relating to the implementation of a postnatal contraception service provision globally will be carried out which will highlight evidence gaps, strengths and weaknesses of studies associated with uptake and known barriers and facilitators to the uptake of early postnatal contraception.Methods and analysis This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The search strategy aims to locate both published and unpublished studies. An initial limited search of PubMed and CINAHL was undertaken to identify articles on the provision of postnatal contraception. The search strategy will be adapted for each included database CINAHL, SCOPUS, MEDLINE, PROSPERO and COCHRANE from 1 January 1993 to 1 January 2023 and reviewed by two reviewers. The data will be analysed and presented in tables, diagrams and text.Ethics and dissemination Ethical approval is not required. This review is a retrospective review of widely and publicly available evidence. The review findings will be disseminated via publication in peer-reviewed journals, as part of a PhD thesis and conference presentation.Scoping review question What are the barriers and facilitators to early postnatal contraception provision and uptake?

Abstract Background Having a body mass index (BMI) which is classified as overweight (BMI ≥ 25) or obese (BMI ≥ 30) increases the risk of complications during pregnancy and labour. Weight-management interventions which target excess gestational weight gain during pregnancy have had limited success. Women who use long-acting reversible contraception (LARC) are in contact with services as part of their preparation for conception, creating a potential opportunity to offer a preconception weight-loss intervention. The aims of this mixed methods study were to assess the acceptability and practicability of a weight-loss intervention which asked people to delay LARC removal in order to lose weight before conceiving. Methods Routine UK NHS data were analysed to identify pathways from LARC removal to pregnancy. Qualitative surveys and advisory group discussions with service providers and LARC users with experience of being overweight were conducted and analysed thematically. Results Three hundred fifteen thousand seven hundred fifty-five UK women aged 16–48 years between 2009–2018 had at least one LARC-related event (e.g. insertion, removal) and 1.7% of those events were recorded as related to planning a pregnancy. BMI was included in 62% of women’s records, with 54% of those BMI being classified as overweight or obese. Online surveys were completed by 100 healthcare practitioners and 243 LARC users. Stakeholders identified facilitators and barriers associated with the proposed intervention including sensitivities of discussing weight, service-user past experiences, practitioner skills, the setting and ethical implications of the proposed intervention. Conclusions Although women and service providers recognised potential benefits, a preconception weight-loss intervention asking people to delay LARC removal posed many barriers, due mainly to the acceptability of such an intervention to women and healthcare practitioners. Weight-loss interventions that target the general population, together with a focus on improving public knowledge of preconception health, may be more acceptable than interventions which solely focus on LARC users. Many of the barriers identified, including communication, understanding and beliefs about weight and risk, appointment systems and the limitations of routine datasets also have relevance for any preconception weight-loss intervention. Work to improve routine datasets and reducing communication barriers to discussing weight are priorities. Trial registration ISRCTN14733020 registered 10.05.2019.

Background Using routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods. Methods Clinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden. Wellbeing Software® provider of the Euroking® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site. Results Twenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records. Discussion Piloting the data extraction and linkage highlighted the need for additional governance arrangements, training at NHS sites and new processes for the study team to ensure data quality and confidentiality are upheld during the study. Amending existing NHS electronic information systems and accessing clinical data at scale, is possible, but continues to be a time consuming and a technically challenging exercise.

Abstract Background Several preconception exposures have been associated with adverse pregnancy, birth and postpartum outcomes. However, few studies have investigated women’s knowledge of and attitudes towards preconception health, and the acceptability of potential intervention methods. Methods Seven primary care centres in the West of England posted questionnaires to 4330 female patients aged 18 to 48 years. Without providing examples, we asked women to list maternal preconception exposures that might affect infant and maternal outcomes, and assessed their knowledge of nine literature-derived risk factors. Attitudes towards preconception health (interest, intentions, self-efficacy and perceived awareness and importance) and the acceptability of intervention delivery methods were also assessed. Multivariable multilevel regression examined participant characteristics associated with these outcomes. Results Of those who received questionnaires, 835 (19.3%) responded. Women were most aware of the preconception risk factors of diet (86.0%) and physical activity (79.2%). Few were aware of weight (40.1%), folic acid (32.9%), abuse (6.3%), advanced age (5.9%) and interpregnancy intervals (0.2%), and none mentioned interpregnancy weight change or excess iron intake. After adjusting for demographic and reproductive covariates, women aged 18–24-years (compared to 40–48-year-olds) and nulligravid women were less aware of the benefit of preconception folic acid supplementation (adjusted odds ratios (aOR) for age: 4.30 [2.10–8.80], gravidity: aOR 2.48 [1.70–3.62]). Younger women were more interested in learning more about preconception health (aOR 0.37 [0.21–0.63]) but nulligravid women were less interested in this (aOR 1.79 [1.30–2.46]). Women with the lowest household incomes (versus the highest) were less aware of preconception weight as a risk factor (aOR: 3.11 [1.65–5.84]) and rated the importance of preconception health lower (aOR 3.38 [1.90–6.00]). The most acceptable information delivery methods were websites/apps (99.5%), printed healthcare materials (98.6%), family/partners (96.3%), schools (94.4%), television (91.9%), pregnancy tests (91.0%) and doctors, midwives and nurses (86.8–97.0%). Dentists (23.9%) and hairdressers/beauticians (18.1%) were the least acceptable. Conclusions Our findings demonstrate a need to promote awareness of preconception risk factors and motivation for preconception health changes, particularly amongst younger and nulligravid women and women with lower incomes. Interventions to improve preconception health should focus on communication from healthcare professionals, schools, family members, and digital media.

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.

Objectives To explore women’s experiences of over-the-counter and prescription medication advice and use during pregnancy.Design A study design consisting of an online survey and nested in-depth interviews with a subsample of participants. We analysed data from survey free-text responses and in-depth interviews using thematic analysis. Quantitative survey data is published elsewhere.Setting The UK.Participants Women were eligible if living in the UK, aged 16–45 years, were pregnant or had been pregnant in the last 5 years regardless of pregnancy outcome. A total of 7090 women completed the survey, and 34 women who collectively had experienced 68 pregnancies were subsequently interviewed.Results Medication prescribing and use during pregnancy was common. The prescribing, dispensing and taking of some advised medications were restricted through women’s or prescribers’ fear of fetal harm. Lack of adherence to national prescribing guidance, conflicting professional opinion and poor communication resulted in maternal anxiety, avoidable morbidity and women negotiating complex and distressing pathways to obtain recommended medications. In contrast, some women felt overmedicated and that pharmacological treatments were used without exploring other options first.Conclusion Increased translation of national guidance into practice and greater personalisation of antenatal care are needed to improve the safety, efficacy and personalisation of prescribing in pregnancy.

Background: Women with overweight (a body mass index of ≥ 25 kg/m2) or obesity (a body mass index of ≥ 30 kg/m2) are at greater risk of experiencing complications during pregnancy and labour than women with a healthy weight. Women who remove their long-acting reversible contraception (i.e. coils or implants) are one of the few groups of people who contact services as part of their preparation for conception, creating an opportunity to offer a weight loss intervention. Objectives: The objectives were to understand if routine NHS data captured the pathway from long-acting reversible contraception removal to pregnancy and included body mass index; to identify the suitable components of a preconception weight loss intervention; and to engage with key stakeholders to determine the acceptability and feasibility of asking women with overweight/obesity to delay the removal of their long-acting reversible contraception in order to take part in a preconception weight loss intervention. Design: This was a preparatory mixed-methods study, assessing the acceptability and feasibility of a potential intervention, using routine NHS data and purposefully collected qualitative data. Participants: The NHS routine data included all women with a long-acting reversible contraception code. There were three groups of participants in the surveys and interviews: health-care practitioners who remove long-acting reversible contraception; weight management consultants; and women of reproductive age with experience of overweight/obesity and of using long-acting reversible contraception. Setting: UK-based health-care practitioners recruited at professional meetings; and weight management consultants and contraceptive users recruited via social media. Data sources: Anonymised routine data from UK sexual health clinics and the Clinical Practice Research Datalink, including the Pregnancy Register; and online surveys and qualitative interviews with stakeholders. Results: The records of 2,632,871 women aged 16–48 years showed that 318,040 had at least one long-acting reversible contraception event, with 62% of records including a body mass index. Given the identified limitations of the routine NHS data sets, it would not be feasible to reliably identify women with overweight/obesity who request a long-acting reversible contraception removal with an intention to become pregnant. Online surveys were completed by 100 health-care practitioners, four weight management consultants and 243 contraceptive users. Ten health-care practitioners and 20 long-acting reversible contraception users completed qualitative interviews. A realist-informed approach generated a hypothesised programme theory. The combination of weight discussions and the delay of long-acting reversible contraception removal was unacceptable as an intervention to contraceptive users for ethical and practical reasons. However, a preconception health intervention incorporating weight loss could be acceptable, and one potential programme is outlined. Limitations: There was very limited engagement with weight management consultants, and the sample of participating stakeholders may not be representative. Conclusions: An intervention that asks women to delay long-acting reversible contraception removal to participate in a preconception weight loss intervention would be neither feasible nor acceptable. A preconception health programme, including weight management, would be welcomed but requires risk communication training of health-care practitioners. Future work: Work to improve routine data sets, increase awareness of the importance of preconception health and overcome health-care practitioner barriers to discussing weight as part of preconception care is a priority. Trial registration: This trial is registered as ISRCTN14733020. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 1.

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.

Objectives The Family Nurse Partnership (FNP) is an intensive home visiting service for teenage first-time mothers, developed/trialled in the US and adapted/trialled across Europe. The Scottish Government aims to build on and supplement the existing evidence base for FNP, to assess effectiveness of the programme, for future improvement work in Scotland. Approach The commissioned natural experiment of FNP, takes advantage of existing information infrastructures in Scotland from health, education and social care and FNP programme implementation data. A cohort design was used covering ten Health Boards in Scotland. The cohort included first-time teenage mothers enrolled as FNP Clients between 2010 and 2016 and women who met FNP eligibility criteria but were pregnant when the programme was not recruiting (Controls). Outcomes are mapped to the Scottish FNP logic model and include those being tested statistically (n=34) or, where direction of effect is uncertain, outcomes are rare or data quality poor, descriptively (n=20). Results We established a model of data linkage to routine Scottish data. Approvals were obtained to access data on over 8000 mothers (FNP Clients and Controls) and their children which formed the study cohort and were mapped to routine health, education and social care data. Outcomes covered maternal (health (smoking, alcohol/drugs), subsequent pregnancies/births, education) and child (health, development, education, protection) domains. Observed baseline imbalances between study arms will be described and adjusted for in modelling. Results will be published by the time of the conference and include sensitivity analyses that explore a priori sub-groups, variation by health board, year of booking and programme dosage. Conclusion The impact of this evaluation will establish a robustly matched study cohort, develop the evidence base on FNP in Scotland and internationally, develop a more streamlined linkage and approval process, and identify outcomes for short-term follow-up and importantly for a longer-term follow-up of the mothers and their children.

Background Stillbirths are reported as one of the most neglected tragedies in global health, with around 2m stillbirths occurring annually and the majority occurring in low- and middle income countries (LMICs). Many antenatal stillbirths are due to preventable conditions such as maternal infections and non-communicable diseases. Almost half of all stillbirths occur during the intrapartum period, with many linked to obstetric complications. Known risk factors for stillbirths overall include young or advancing maternal age, fetal infection, maternal hypertensive conditions, perinatal asphyxia, history of previous stillbirth, obstetric complications, intrauterine growth restriction and abruptio placenta/placenta praevia. Common non-clinical risk factors include lack of education, socioeconomic deprivation and substandard antenatal care. Methods A single site prospective observational study conducted over three-months was conducted in a tertiary referral hospital in Kano, Nigeria. Eligible participants were mothers presenting at the site in labour and their babies. Demographic and clinical data were collected by paper-based questionnaires. Data were collected on living environment, health and medical history, pregnancy history and pregnancy/birth factors. Each mother answered pre-delivery questions, with potential follow-on questions dependent on birth outcome. Further data points were collected from clinical observations. Photographs were taken of stillborn babies to support data collected and to aid the UK team on classifying degrees of maceration in an attempt to identify antenatal and intrapartum fetal death. Findings Higher odds of stillbirth were associated with low levels of education, a further distance to travel from home to the hospital, living in a shack, maternal hypertension and having had a previous stillbirth after adjusting for all sociodemographic and health features. Higher odds of intrapartum stillbirth included; shoulder presentation, compound presentation and breech presentation compared to cephalic presentation. Other birth related factors associated with higher odds of stillbirth included reported birthing complications, duration of labour being >=18 hours), antepartum haemorrhage, prolonged/obstructed labour, vaginal breech delivery, emergency Caesarean-section delivery, and signs of trauma to the neonate. Conclusions Identified risk factors associated with stillbirths are relatively amenable to intervention and a lot of work has been conducted globally, so the development of intervention with sufficient funding should be a relatively rapid process. For collaborations please contact: Email: miltonrl1@cardiff.ac.uk

Objectives Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs.Design Follow-up of BB:0–2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage.Participants 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0–2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone.Outcome measures Primary outcome: state-verified child-in-need status recorded at any time during follow-up. Secondary outcomes: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs.Results Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs.Conclusions FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1.Trial registration number ISRCTN23019866.

ObjectiveWomen of reproductive age who have autoimmune rheumatic diseases [ARDs] have expressed a need to be better supported with making decisions about pregnancy. Women with ARDs want their motherhood identities and associated preferences to be taken into account in decisions about their healthcare. The aim of this study was to explore the interplay between illness and motherhood identities of women with ARDs during preconception decision making.MethodsTimeline-facilitated qualitative interviews with women diagnosed with an ARD [18-49 years old]. Participants were purposively sampled based on the following three criteria: thinking about getting pregnant, currently pregnant, or had young children. Interviews were thematically analysed.ResultsTwenty-two women were interviewed face-to-face [N = 6] or over the telephone [N = 16]. Interview length ranged from 20 minutes to 70 minutes, with a mean length of 48 minutes. Three main themes were identified: prioritisation, discrepancy, and trade-off. Difficulties in balancing multiple identities in healthcare encounters were reported. Women used 'self-guides' as a reference for priority setting in a dynamic process that shifted as their level of disease activity altered and as their motherhood identity became more or less of a focus at a given point in time. Women's illness and motherhood identities did not present in isolation but were intertwined.ConclusionsFindings highlight the need for holistic person-centred care that supports women with the complex and emotive decisions relating to preconception decision-making. In practice, health professionals need to consider women's multiple and sometimes conflicting identities, and include both their condition and family associated goals and values within healthcare communication.

Abstract Background Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical and social AEs, and develop a model for conceptualising safety monitoring. Methods The Building Blocks randomised controlled trial of specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites. Event reports collected during follow-up were independently reviewed and categorised as either Medical (standard Good Clinical Practice definition), or Social (trial-specific definition). A retrospectively developed system was created to classify AEs. Univariate analyses explored the association between baseline participant and study characteristics and the subsequent reporting of events. Factors significantly associated at this stage were progressed to binary logistic regressions to assess independent predictors. Results A classification system was derived for reported AEs that distinguished between Medical or Social AEs. One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social). Allocation to the trial intervention arm was associated with increased likelihood of Medical rather than Social AE reporting. Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events. Baseline predictors of Social AEs included being younger at recruitment (OR = 0.78 (CI = 0.67 to 0.90), p = 0.001), receiving benefits (OR = 1.60 (CI = 1.09 to 2.35), p = 0.016), and having a higher antisocial behaviour score (OR = 1.22 (CI = 1.09 to 1.36), p

Background: The UK print and online media is an important channel by which scientific research is communicated to the public. Media risk messages relating to pregnancy or fertility contribute to the context of reproductive decision making, but their fidelity to the underlying science has been questioned. Method: We measured the volume, distribution and content of science-based risk headlines relating to pregnancy or fertility in the UK media over four months. We grouped headlines into unique stories and categorised them by exposure and outcome of interest. We selected four unique stories for closer content analysis and assessed their fidelity to the underlying science, with attention to the role of press releases. Results: We identified 171 headlines over four months (average 43 per month), comprising 56 unique stories. The unique stories most commonly concerned maternal risk factors (n=46) and child health outcomes (n=46). Maternal health outcomes were less frequently the focus (n=20). The most common risk factors in the media coverage were maternal food and drink (n=15), maternal medication and medical interventions (n=9), and maternal health factors (n=6). Media reports were largely faithful to press releases. Where substantive deviations from the underlying scientific study were identified, these could mostly be traced back to press releases or quotes from the study’s authors. Press releases often omitted caveats which were reinstated at the media reporting stage, alongside additional expert criticism. Conclusions: Frequent science-based risk messages in the UK media frame mothers as vectors of potential harm to children, who are the focus of health outcomes. Largely, the media does not introduce misinformation, but reports press releases faithfully with additional caveats and expert commentary. Press releases fulfil an interpretative role, often omitting caveats and introducing new elements and advice to women. Their role as a bridge between scientific and lay audiences is discussed.

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.

Background: The short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0–2). Objectives: The objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership. Design: Children and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age. Setting: This study was set in 18 partnerships between local authorities and health-care organisations in England. Participants: The participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged ≤ 19 years, in local authority Family Nurse Partnership catchment areas, at

Background: Currently, pregnant women are screened using ultrasound to perform gestational aging, typically at around 12 weeks’ gestation, and around the middle of pregnancy. Ultrasound scans thereafter are performed for clinical indications only. Objectives: We sought to assess the case for offering universal late pregnancy ultrasound to all nulliparous women in the UK. The main questions addressed were the diagnostic effectiveness of universal late pregnancy ultrasound to predict adverse outcomes and the cost-effectiveness of either implementing universal ultrasound or conducting further research in this area. Design: We performed diagnostic test accuracy reviews of five ultrasonic measurements in late pregnancy. We conducted cost-effectiveness and value-of-information analyses of screening for fetal presentation, screening for small for gestational age fetuses and screening for large for gestational age fetuses. Finally, we conducted a survey and a focus group to determine the willingness of women to participate in a future randomised controlled trial. Data sources: We searched MEDLINE, EMBASE and the Cochrane Library from inception to June 2019. Review methods: The protocol for the review was designed a priori and registered. Eligible studies were identified using keywords, with no restrictions for language or location. The risk of bias in studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Health economic modelling employed a decision tree analysed via Monte Carlo simulation. Health outcomes were from the fetal perspective and presented as quality-adjusted life-years. Costs were from the perspective of the public sector, defined as NHS England, and the costs of special educational needs. All costs and quality-adjusted life-years were discounted by 3.5% per annum and the reference case time horizon was 20 years. Results: Umbilical artery Doppler flow velocimetry, cerebroplacental ratio, severe oligohydramnios and borderline oligohydramnios were all either non-predictive or weakly predictive of the risk of neonatal morbidity (summary positive likelihood ratios between 1 and 2) and were all weakly predictive of the risk of delivering a small for gestational age infant (summary positive likelihood ratios between 2 and 4). Suspicion of fetal macrosomia is strongly predictive of the risk of delivering a large infant, but it is only weakly, albeit statistically significantly, predictive of the risk of shoulder dystocia. Very few studies blinded the result of the ultrasound scan and most studies were rated as being at a high risk of bias as a result of treatment paradox, ascertainment bias or iatrogenic harm. Health economic analysis indicated that universal ultrasound for fetal presentation only may be both clinically and economically justified on the basis of existing evidence. Universal ultrasound including fetal biometry was of borderline cost-effectiveness and was sensitive to assumptions. Value-of-information analysis indicated that the parameter that had the largest impact on decision uncertainty was the net difference in cost between an induced delivery and expectant management. Limitations: The primary literature on the diagnostic effectiveness of ultrasound in late pregnancy is weak. Value-of-information analysis may have underestimated the uncertainty in the literature as it was focused on the internal validity of parameters, which is quantified, whereas the greatest uncertainty may be in the external validity to the research question, which is unquantified. Conclusions: Universal screening for presentation at term may be justified on the basis of current knowledge. The current literature does not support universal ultrasonic screening for fetal growth disorders. Future work: We describe proof-of-principle randomised controlled trials that could better inform the case for screening using ultrasound in late pregnancy. Study registration: This study is registered as PROSPERO CRD42017064093. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 15. See the NIHR Journals Library website for further project information.

Introduction Approximately 60 000 (9/100) infants are born into water annually in the UK and this is likely to increase. Case reports identified infants with water inhalation or sepsis following birth in water and there is a concern that women giving birth in water may sustain more complex perineal trauma. There have not been studies large enough to show whether waterbirth increases these poor outcomes. The POOL Study (ISRCTN13315580) plans to answer the question about the safety of waterbirths among women who are classified appropriate for midwifery-led intrapartum care.Methods and analysis A cohort study with a nested qualitative component. Objectives will be answered using retrospective and prospective data captured in electronic National Health Service (NHS) maternity and neonatal systems. The qualitative component aims to explore factors influencing pool use and waterbirth; data will be gathered via discussion groups, interviews and case studies of maternity units.Ethics and dissemination The protocol has been approved by NHS Wales Research Ethics Committee (18/WA/0291) the transfer of identifiable data has been approved by Health Research Authority Confidentiality Advisory Group (18CAG0153).Study findings and innovative methodology will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the general public, clinical and policy stakeholders in the UK and will be disseminated accordingly.

Abstract Around half of pregnant women in the United Kingdom are overweight or obese. The antenatal period provides an opportunity for encouraging women to adopt positive lifestyle changes, and in recent years, this has included development of strategies to support women in avoiding excessive gestational weight gain. The objective of this interventional cohort study was to incorporate individualised gestational weight monitoring charts supported by motivational interviewing (MI)‐based conversations into midwifery‐led antenatal care and assess potential of the intervention for further development and evaluation. The study setting was a community midwifery team within a large maternity unit. The study explored the facilitators and barriers to engagement with the intervention as experienced by women and midwives; 52 women were recruited, of whom 48 were included in the analysis. A single training session was found adequate to prepare midwives to use antenatal weight charts but was insufficient to result in the incorporation of motivational interview techniques into clinical practice. We did not find sufficient evidence to recommend effectiveness testing of this intervention, and there is currently insufficient evidence to support reintroducing regular weighing of pregnant women into UK antenatal care. Given the public health importance of reducing rates of obesity, future interventions aimed at controlling gestational weight gain should continue to be developed but need to include innovative strategies particularly for women who are already obese or gain weight above that recommended.

Abstract Background Autoimmune rheumatic diseases (ARDs) such as inflammatory arthritis and Lupus, and many of the treatments for these diseases, can have a detrimental impact on fertility and pregnancy outcomes. Disease activity and organ damage as a result of ARDs can affect maternal and foetal outcomes. The safety and acceptability of hormonal contraceptives can also be affected. The objective of this study was to identify the information and support needs of women with ARDs during pregnancy planning, pregnancy and early parenting. Methods This mixed methods study included a cross-sectional online survey and qualitative narrative interviews. The survey was completed by 128 women, aged 18–49 in the United Kingdom with an ARD who were thinking of getting pregnant in the next five years, who were pregnant, or had young children (

Abstract Background Many women in the UK stop breastfeeding before they would like to, and earlier than is recommended by the World Health Organization (WHO). Given the potential health benefits for mother and baby, new ways of supporting women to breastfeed for longer are required. The purpose of this study was to develop and characterise a novel Motivational Interviewing (MI) informed breastfeeding peer-support intervention. Methods Qualitative interviews with health professionals and service providers (n = 14), and focus groups with mothers (n = 14), fathers (n = 3), and breastfeeding peer-supporters (n = 15) were carried out to understand experiences of breastfeeding peer-support and identify intervention options. Data were audio-recorded, transcribed, and analysed thematically. Consultation took place with a combined professional and lay Stakeholder Group (n = 23). The Behaviour Change Wheel (BCW) guided intervention development process used the findings of the qualitative research and stakeholder consultation, alongside evidence from existing literature, to identify: the target behaviour to be changed; sources of this behaviour based on the Capability, Opportunity and Motivation (COM-B) model; intervention functions that could alter this behaviour; and; mode of delivery for the intervention. Behaviour change techniques included in the intervention were categorised using the Behaviour Change Technique Taxonomy Version 1 (BCTTv1). Results Building knowledge, skills, confidence, and providing social support were perceived to be key functions of breastfeeding peer-support interventions that aim to decrease early discontinuation of breastfeeding. These features of breastfeeding peer-support mapped onto the BCW education, training, modelling and environmental restructuring intervention functions. Behaviour change techniques (BCTTv1) included social support, problem solving, and goal setting. The intervention included important inter-personal relational features (e.g. trust, honesty, kindness), and the BCTTv1 needed adaptation to incorporate this. Conclusions The MI-informed breastfeeding peer-support intervention developed using this systematic and user-informed approach has a clear theoretical basis and well-described behaviour change techniques. The process described could be useful in developing other complex interventions that incorporate peer-support and/or MI.

Visual timeline methods have been used as part of face-to-face qualitative interviewing with vulnerable populations to uncover the intricacies of lived experiences, but little is known about whether visual timelines can be effectively used in telephone interviews. In this article, we reflect on the process of using visual timelines in 16 telephone interviews with women as part of the “STarting a family when you have an Autoimmune Rheumatic disease” study (STAR Family Study). The visual timeline method was used to empower women to organize and share their narratives about the sensitive and complex topic of starting a family. We conducted a thematic analysis of the audio-recorded interview data, using researchers’ field notes and reflections to provide context for our understanding of the benefits of using timelines and to understand the process of using visual timelines during telephone interviews. Resource packs were sent to women before study participation; 11 of the 16 women completed a version of the timeline activity. Six themes were identified in the methodological data analysis: (1) use and adaptation of the timeline tool, (2) timeline exchange, (3) framing the interview: emphasizing that women are in control, (4) jumping straight in, (5) taking a lead, and (6) disclosing personal and sensitive experiences. The use of visual timelines facilitated interviewee control and elicited rich narratives of participants’ experiences in telephone interviews. Women created their visual timelines autonomously and retained ownership of their timeline data; these features of the data generation process need to be considered when using visual timelines in telephone rather than face-to-face interviews. Use of visual methods within telephone interviews is feasible, can generate rich data, and should be further explored in a wider range of settings.

Introduction: Individual, social and economic circumstances faced by young mothers can challenge a successful start in life for their children. Intervening early might enhance life chances for both mother and child. The Family Nurse Partnership (FNP) is an intensive nurse-led home visiting programme developed in the US which aims to improve prenatal health behaviours, birth outcomes, child development and health outcomes, and maternal life course. Establishing evidence of effectiveness beyond the original US setting is important to understand where further adaptation is required within a country specific context. Objective: This study will form one strand of the Scottish Governments’ plan to evaluate the effectiveness of FNP as compared to usual care for mothers and their children in Scotland and will focus only on outcomes that can be identified using routine administrative data systems. Methods: This study is a natural experiment with a case-cohort design using linked anonymised routine health, educational and social care data. Cases will be women enrolled as FNP Clients in ten NHS Health Boards in Scotland and Controls will be women who met FNP eligibility criteria but were pregnant at a time when the programme was not recruiting. Outcomes are mapped to the Scottish FNP logic model. All comparative analyses will be pre-specified, conducted on an intention to treat basis and will use multilevel regression models to compare outcomes between groups. Discussion: The study protocol is based upon the specification of FNP commissioned by the Scottish Government. This study design is novel for the evaluation of the FNP/NFP programmes which are primarily evaluated with an RCT. Outcomes included within the study have been selected on the basis that they are outcomes FNP aims to influence and where there is routine data available to assess the outcome.

Background POOL is a cohort study designed to establish whether waterbirth, compared to leaving a pool prior to birth, is as safe for mothers and infants. It is a novel case study using routine maternity and neonatal data for research purposes, including the adaptation and addition of locally collected electronic data at sites. Aim We aimed to establish the feasibility of the study design, which combines data from maternity information systems(MIS) and neonatal data using a dissent-based linkage model and the addition of new variables into the MIS. Methods The study will utilise individual level data entered into local MIS at 30 NHS Trusts linked with the National Neonatal Research Database(NNRD). New variables were added to one pilot site before rolling out to the remaining sites. A third party added the new variables, extracted data from the MIS to send to the study team and transferred data for matching to the NNRD, ensuring the study team receive only anonymised data. The feasibility study aimed to establish the quality and completion of the newly added variables, the levels of missingness for key outcomes from an extract of 4 years of retrospective data, and ensured the datasets could link using the study ID generated by our third party. Results The new variables were added into the MIS and data were extracted after a 10week pilot. New variables were present and had been entered as per specified metadata requirements. 23,140 records were extracted from the retrospective data and key variables assessed for missingness e.g.place of birth(

Background: Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. Objectives: To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. Design: A multicentre, randomised, blinded, placebo-controlled trial. Setting: Twenty-seven maternity units in the UK. Participants: Women who had an operative vaginal birth at ≥ 36 weeks’ gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. Interventions: A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. Main outcome measures: Primary outcome – confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes – severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. Results: Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). Limitations: The follow-up rate achieved for most secondary outcomes was 76%. Conclusions: This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. Trial registration: Current Controlled Trials ISRCTN11166984. Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.

Background: The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach. Methods: A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes. Results: A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes. Conclusion: Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment. Trial registration: ISRCTN23019866 (20/04/2009)

Introduction The Family Nurse Partnership(FNP) is an intensive home-visiting service for teenage first-time mothers (and children), developed/trialled in the US and adapted/trialled across Europe.The Scottish Government(SG) aims to build on and supplement the existing national/international evidence base for FNP, to assess effectiveness and opportunities for optimisation of the programme, for future decision making in Scotland. Objectives and Approach The evaluation commissioned is a natural experiment of FNP, taking advantage of the existing information infrastructure in Scotland. This natural experiment represents an important opportunity to determine programme impact upon many key programme outcomes using routinely collected data at a lower cost than a comparably sized effectiveness trial. Key objectives are: to identify clients in receipt of FNP-support and a control sample of matched families who would meet criteria for FNP but did not receive support, to obtain approval and through anonymised data linkage link to health and other data, and to determine the effect of FNP across a range of maternal and child outcomes. Results The succes of the natural experiment design in trying to replicate the gold standard design of the RCT will be presented and will cover the following topics: (how cases and a comparable group of first-time teenage women have been identified across 10 Health Boards (HBs) between 2009 and 2016 using data made available by the electronic Data Research and Innovation Service (eDRIS) from FNP, NHS Scotland and SG; the matching process of the cases and controls using propensity score methods to ensure an unbiased comparison; the linkage to health, social care and educational datasets and the approval processes involved, and the strengths and limitations of using routine data to evaluate relevant study outcomes that map to a logic model. Conclusion/Implications The impact of this evaluation into the effectiveness of FNP in Scotland will establish a robustly matched study cohort, a more strealmined linkage and approval process, and identification of outcomes not only for a short-term follow-up but also for a longer-term follow-up of the teenage mothers and their children.

Background:Women with autoimmune rheumatic diseases (ARDs) find it difficult to get information and support with family planning, pregnancy, and early parenting. A systematic approach to prioritising research is required to accelerate development and evaluation of interventions to meet the complex needs of this population. Methods:A Nominal Group Technique (NGT) exercise was carried out with lay and professional stakeholders (n=29). Stakeholders were prepared for debate through presentation of available evidence. Stakeholders completed three tasks to develop, individually rank, and reach consensus on research priorities: Task 1 – mapping challenges and services using visual timelines; Task 2 - identifying research topics; Task 3 - individually ranking research topics in priority order. Results of the ranking exercise were fed back to the group for comment. Results:The main themes emerging from Task 1 were the need for provision of information, multi-disciplinary care, and social and peer support. In Task 2, 15 research topics and 58 sub-topics were identified around addressing the challenges and gaps in care identified during Task 1. In Task 3, a consensus was reached on the ten research topics that should be given the highest priority. These were individually ranked, resulting in the following order of priorities (from 1 – highest to 10 – lowest): 1. Shared decision-making early in the care pathway; 2. Pre-conception counseling; 3. Information about medication use during pregnancy/breastfeeding; 4. Personalised care planning; 5. Support for partners/family members; 6. Information about local support/disease specific issues; 7. Shared decision-making across the care pathway; 8. Peer-support; 9. Social inequalities in care, and; 10. Guidance on holistic/alternative therapies. Conclusions:This systematic approach to identification of research priorities from a multi-disciplinary and lay perspective indicated that activities should focus on development and evaluation of interventions that increase patient involvement in clinical decision-making, multi-disciplinary models of care, and timely provision of information.

Background: In total, 81% of women in the UK start breastfeeding, but fewer than half continue beyond 6 weeks. Peer support in the early postnatal period may encourage women to breastfeed for longer. Objective: To develop a breastfeeding peer-support intervention based on motivational interviewing (MI) for breastfeeding maintenance and to test the feasibility of delivering it to mothers in areas with high levels of social deprivation. Design: Intervention development and a non-randomised multisite feasibility study. Setting: Community maternity services in three areas with high levels of social deprivation and low breastfeeding initiation rates in England and Wales. Participants: Pregnant women considering breastfeeding. Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded. Intervention: The intervention Mam-Kind was informed by a survey of infant feeding co-ordinators, rapid literature review, focus groups with service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group. It consisted of face-to-face contact at 48 hours after birth and proactive one-to-one peer support from the Mam-Kind buddy for 2 weeks, followed by mother-led contact for a further 2–6 weeks. Main outcome measures: Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals. Results: Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study). Participants were aged between 19 and 41 years and 94% of participants were white. Intervention uptake was 75% and did not vary according to age or parity. Most contacts (79%) were initiated by the buddy, demonstrating the intended proactive nature of the intervention and 73% (n = 51) of participants received a contact within 48 hours. Follow-up data were available for 78% of participants at 10 days and 64% at 8 weeks. Data collection methods were judged feasible and acceptable. Data completeness was > 80% for almost all variables. Interviews with participants, buddies and health service professionals showed that the intervention was acceptable. Buddies delivered the intervention content with fidelity (93% of intervention objectives were met), and, in some cases, developed certain MI skills to a competency level. However, they reported difficulties in changing from an information-giving role to a collaborative approach. These findings were used to refine the training and intervention specification to emphasise the focus of the intervention on providing mother-centric support. Health-care professionals were satisfied that the intervention could be integrated with existing services. Conclusions: The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial. The feasibility study highlighted the need to strengthen strategies for birth notification and retention of participants, and provided some insights on how this could be achieved in a full trial. Limitations: The response rate to the survey of infant feeding co-ordinators was low (19.5%). In addition, the women who were recruited may not be representative of the study sites. Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Epidural analgesia leads to increased risk of instrumental vaginal delivery (IVD). There is debate about whether or not posture in second-stage labour influences the incidence of spontaneous vaginal birth (SVB). Objectives: In nulliparous women with epidural analgesia, does a policy of adopting an ‘upright position’ throughout second-stage labour increase the incidence of SVB compared with a policy of adopting a ‘lying-down’ position? Design: Two-arm randomised controlled trial. Setting: Maternity units in England and Wales. Participants: Nulliparous women aged ≥ 16 years, at ≥ 37 weeks’ gestation with singleton cephalic presentation and intended SVB, in second-stage labour with an epidural providing effective pain relief. Interventions: (1) Upright position to maintain the pelvis in as vertical a plane as possible; and (2) lying-down position to maintain the pelvis in as horizontal a plane as possible. Main outcome measures: The primary outcome measure was incidence of SVB. Secondary outcomes included augmentation, interventions to maintain blood pressure, duration of labour, episiotomy, genital tract trauma, post-partum haemorrhage, maternal satisfaction, neonatal metabolic acidosis, 5-minute Apgar score of

In Philadelphia, 66% of new HIV infections are among African Americans and 2% of African Americans are living with HIV. The city of Philadelphia has among the largest numbers of faith institutions of any city in the country. Although faith-based institutions play an important role in the African American community, their response to the AIDS epidemic has historically been lacking. We convened 38 of Philadelphia's most influential African American faith leaders for in-depth interviews and focus groups examining the role of faith-based institutions in HIV prevention. Participants were asked to comment on barriers to engaging faith-based leaders in HIV prevention and were asked to provide normative recommendations for how African American faith institutions can enhance HIV/AIDS prevention and reduce racial disparities in HIV infection. Many faith leaders cited lack of knowledge about Philadelphia's racial disparities in HIV infection as a common reason for not previously engaging in HIV programs; others noted their congregations' existing HIV prevention and outreach programs and shared lessons learned. Barriers to engaging the faith community in HIV prevention included: concerns about tacitly endorsing extramarital sex by promoting condom use, lack of educational information appropriate for a faith-based audience, and fear of losing congregants and revenue as a result of discussing human sexuality and HIV/AIDS from the pulpit. However, many leaders expressed a moral imperative to respond to the AIDS epidemic, and believed clergy should play a greater role in HIV prevention. Many participants noted that controversy surrounding homosexuality has historically divided the faith community and prohibited an appropriate response to the epidemic; many expressed interest in balancing traditional theology with practical public health approaches to HIV prevention. Leaders suggested the faith community should: promote HIV testing, including during or after worship services and in clinical settings; integrate HIV/AIDS topics into health messaging and sermons; couch HIV/AIDS in social justice, human rights and public health language rather than in sexual risk behavior terms; embrace diverse approaches to HIV prevention in their houses of worship; conduct community outreach and host educational sessions for youth; and collaborate on a citywide, interfaith HIV testing and prevention campaign to combat stigma and raise awareness about the African American epidemic. Many African American faith-based leaders are poised to address racial disparities in HIV infection. HIV prevention campaigns should integrate leaders' recommendations for tailoring HIV prevention for a faith-based audience.

Background: Complex health and social care interventions impact on a multitude of outcomes. One such intervention is the Family Nurse Partnership (FNP) programme, which was introduced to support young, first-time mothers. Our study quantified the relative values that the general public place on the outcomes of FNP, as they were identified and measured in the relevant randomized trial, Building Blocks trial (BBs). Methods: A discrete choice experiment (DCE) was employed. Respondents chose between two scenarios describing hypothetical sets of trial outcomes. BBs compared FNP care for teenagers expecting their first child with standard NHS care. 14 attributes covered three areas: pregnancy and birth, child development and maternal life course. Due to large number of attributes, a “blocked attributes” approach was adopted: the attributes were split across four designs which contained two common attributes. Data were analysed separately for each design as well as pooled across four designs. Random effects probit model was employed for the analysis. Results: Over 1000 participants completed four designs. The analyses on the separate designs and those on pooled data yielded broadly similar results. Respondents valued higher the outcomes related to child development and their needs, followed by the outcomes related to maternal life course. Preferences varied by the age of the respondents but not by their guardianship/parentship status. Conclusions: Individual preferences were consistent with a priori expectations and were intuitive. The DCE results can be used to incorporate the general public preferences into the decision making process for which public health and social care policies should be adopted.