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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.

Musculoskeletal infections originate from pathogens introduced into the tissues via direct inoculation, through hematogenous spread, or via contiguous extension from adjacent areas of infection. In pediatric patients, these infections are a common cause of morbidity, with the possibility of long-term functional impairment. Prompt diagnosis and treatment are important to prevent irreversible damage to the bones and joint space, to decrease length of hospital stay, and to minimize treatment morbidity. While pediatric orthopaedic surgeons may definitively manage these cases, multidisciplinary collaboration provides the best outcomes for patients. Cases of severe musculoskeletal infection should be managed urgently or emergently. However, management decisions often vary between physicians and institutions, including when to perform imaging, whether to use sedation or contrast with MRIs, and whether to take these cases during daytime operating room block hours or overnight. Increasing data about bacteria, the immune response, and antibiotic susceptibility have influenced and standardized many hospital practice guidelines. However, interinstitutional variation in care pathways still exists and may be attributed to differences in endemic bacteria. Standardization of treatment algorithms and protocols improves patient outcomes, but they must be modified for regional bacterial prevalence and antibiograms. This manuscript addresses the management of common pediatric musculoskeletal infections through a case-based, roundtable approach with national experts.

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 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.

ObjectivesThe 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. ApproachThe 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). ResultsWe 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. ConclusionThe 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:Women who have experienced a postpartum haemorrhage (PPH) ‘requiring treatment or transfusion’ are typically advised to plan birth in obstetric-led settings in subsequent pregnancies. Many UK alongside midwifery units (AMU) admit women for labour care following a previous PPH. We aimed to describe outcomes in women admitted for labour care to AMUs following a previous PPH, compare outcomes with other multiparous women admitted to the same AMUs, and explore risk factors for recurrence. Methods:A national cohort and nested case-control study using the UK Midwifery Study System (UKMidSS), between August 2018 and April 2019. Multivariable Poisson regression and logistic regression were performed to compare outcomes and investigate risk factors for recurrence. Findings:Women who experienced a previous PPH were significantly more likely than comparison women to: have a PPH requiring transfer to obstetric care (4·2% vs. 2·4%, aRR=1·65, 95% CI 1·14–2·38), be transferred to obstetric care for any reason (17·8% vs 11·9%; aRR=1·41; 95% CI 1·09–1·83), and have any PPH≥500ml (22·7% vs 11·1%, aRR=1·86, 95% CI 1·49–2·32). Among women with a previous PPH, previous blood loss >1500ml; uterotonics for previous PPH; Caesarean associated with previous PPH; gestation at admission and higher birthweight were independent risk factors for PPH. Conclusion:Women considering birth in an AMU after a previous PPH should be advised that they are at increased risk of experiencing a subsequent PPH requiring transfer to obstetric care, compared with other multiparous women who have not had a PPH. The absolute risk of a subsequent PPH in this group is low and comparable to the overall risk of having a PPH among women having a spontaneous vaginal birth in England.

Studies on the TSH receptor (TSHR) have numerous practical applications in vitro and in vivo. For example human monoclonal autoantibodies (MAbs) to the TSHR are useful reagents for in vitro diagnostics. Measurement of TSHR autoantibodies (TRAbs) is helpful in diagnosis and management of autoimmune thyroid disease. Currently available highly sensitive and specific assays to measure TRAbs use the human TSHR MAb M22 instead of the TSH. Furthermore, preparations of the human TSHR MAb M22 are useful as the World Health Organisation International Standard for thyroid stimulating antibody and for calibration of the assays for measuring TRAbs. Preparations of thermostabilised TSHR extracellular domain have recently become available and this is likely to have an impact on improvements in specificity testing for TRAb assays. In addition the stable TSHR preparations have practical application for specific immunoadsorption of patient serum TRAbs. Human TSHR MAbs also have promising prospects as new therapeutics. Autoantibodies with TSHR antagonistic activities are “natural” inhibitors of TSHR stimulation and are expected to be helpful in controlling TSHR activity in patients with Graves’ disease, Graves’ ophthalmopathy and thyroid cancer.

Objective We aimed to document and describe variation in a range of factors impacting on preparedness for and the management of emergencies in midwifery units in the UK. Design, setting and participants National cross-sectional survey administered online through the UK Midwifery Study System (UKMidSS) to midwife ‘reporters’ in all 206 alongside and freestanding midwifery units in the UK, January-April 2020. Topics investigated included communication with the ambulance service in freestanding units, staff support for emergencies, training and equipment held. Findings In total, 137 (67%) midwifery units responded, representing 75% of eligible UK maternity services. There was no evidence of differences between responding and non-responding units in terms of type of unit, annual number of births, or country/region of the UK. Overall, 10 freestanding units (20%) reported using an ordered categorical system (e.g. ‘category 1’ or ‘code red’) to communicate an emergency to the ambulance service, 17 (35%) reported using other words describing urgency (e.g. ‘obstetric emergency’), and 15 (31%) reported having no agreed word or phrase. Almost all alongside units reported that a senior midwife, paediatrician/neonatologist and obstetrician might attend in an emergency, whereas most freestanding units reported the attendance of paramedics and/or a senior midwife. The type and frequency of staff training varied, with 77% of units reporting annual skills and drills training, and lower proportions reporting annual multi-disciplinary simulation (55%), in-situ simulation (50%) and neonatal life support training (59%). The equipment kept in midwifery units varied between different types of unit. For example, 28 alongside units (32%) reported keeping ventouse in the unit and 21 (24%) kept forceps, compared with 4 (8%) and 2 (4%) freestanding units respectively. Almost half of freestanding units (47%) and around a quarter of alongside units (24%) reported having a cardiotocograph (CTG) in the unit. Conclusions The study found wide variation in factors that impact on preparedness for and management of emergencies in UK midwifery units. Although some variation is inevitable given the varying size and location of units, this study has identified some areas where greater consistency might improve outcomes.

Background\ud Women receive many public health messages relating to pregnancy which are intended to improve outcomes for babies and mothers. However, negotiating the risk landscape and maternity care system can feel confusing and disempowering. Relationships between women and their healthcare providers are paramount, but they can be adversely affected by issues of trust and autonomy.\ud \ud Methods\ud We used a nested study design including an online survey and qualitative interviews to gain an understanding of women's experiences of risk messages during pregnancy. We purposively sampled survey participants to ensure the interview population included women whose voices are seldom heard and are disproportionately impacted by poor risk communication.\ud \ud Results\ud A total of 7,009 women responded to the survey, and 34 women participated in interviews. Participants received public health and risk messages from a range of sources. Data showed that women wanted a balance between a “better safe than sorry” approach and evidence-based information and advice. Women reported a discrepancy between the topics they received a lot of information on and areas in which they felt they needed more advice. Many participants said they were given conflicting advice, and the way information was delivered sometimes challenged their autonomy. We identified that younger women (

BackgroundInduction of Labour (IOL) is an increasingly common obstetric intervention, offered to 30-50% of pregnant women in the UK. IOL affects experience of childbirth: it is more painful than spontaneous labour and more likely to lead to additional interventions including operative birth. Experience of childbirth is important to women, and negative experience of childbirth has been linked to serious psychological harm. The high and rising rate of IOL has implications for provision of safe, effective, person-centred maternity services, yet there is little information about women’s experiences of induction.AimTo explore women’s views and experiences of key elements of the IOL process, including at home or in hospital cervical ripening (CR)MethodsA questionnaire-based postnatal survey of 309 women who had IOL at UK maternity units in 2021/22, undertaken as part of the CHOICE Study process evaluation The questionnaire was administered online and included fixed response and free text options. Findings are reported as descriptive statistics with content analysis of women’s comments providing context.FindingsInformation 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.ConclusionsWomen 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.

BackgroundPreconception exposures have been associated with adverse pregnancy, birth and postpartum outcomes. However, the reports, statements and guidelines of national and international health organisations vary in what they recommend individuals should monitor, avoid, reduce or practise in the preconception period.ObjectivesTo synthesise and evaluate the evidence across systematic reviews for associations between exposures before conception and adverse pregnancy, birth and postpartum outcomes.Data sourcesMEDLINE, Embase, Epistemonikos (to May 2020) and reference lists of included reviews, without language or date restrictions.Study selection, data extraction and synthesisSystematic literature reviews of observational and/or interventional studies reporting associations between preconception exposures in women and/or men of reproductive age and pregnancy, birth or postpartum health outcomes were included. The methodological quality of reviews and the certainty of the evidence underlying each exposure-outcome association were assessed using AMSTAR 2 and the GRADE approach.ResultsWe identified 53 eligible reviews reporting 205 unique exposure-outcome associations. Methodological quality was generally low with only two reviews rated as ‘high’ quality and two as ‘moderate’. We found high-certainty, randomised trial evidence that maternal folate supplementation reduces the risk of neural tube defects and anomaly-related terminations. Moderate-certainty, observational evidence was found that maternal physical activity is associated with reduced risk of pre-eclampsia and gestational diabetes, and that paternal age of ≥40 years and maternal body mass index (BMI) and interpregnancy weight gain are associated with increased risk of various adverse pregnancy and birth outcomes. Low- and very low-certainty evidence was found for other associations.ConclusionsClinicians and policymakers can be confident that maternal folate supplementation should be encouraged during the preconception period. There is moderate certainty in the evidence base that maternal physical activity, BMI and interpregnancy weight gain and advanced paternal age are important preconception considerations. High-quality research is required to better understand other exposure-outcome associations.

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. ConclusionsIdentified 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

Objective Women 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. Methods Timeline-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. Results Twenty-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. Conclusions Findings 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.

ObjectivesMeasure 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.DesignFollow-up of BB:0–2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage.Participants1618 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 measuresPrimary 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.ResultsMatch 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.ConclusionsFNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1.Trial registration numberISRCTN23019866.

ObjectivesTo explore women’s experiences of over-the-counter and prescription medication advice and use during pregnancy.DesignA 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.SettingThe UK.ParticipantsWomen 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.ResultsMedication 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.ConclusionIncreased 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.

Objectives\udTo assess the prevalence of self-reported mental health problems in a cohort of women in early pregnancy.\ud\udTo describe the relationship between poor mental health and sociodemographic characteristics, self-efficacy and support networks.\ud\udTo assess if participants were representative of the local antenatal population.\ud\udResearch design and setting\udThe UK government has pledged money to provide more support for women with perinatal mental health issues. Understanding the prevalence and predicting women who may need support will inform clinical practice. This paper reports part of the larger ‘Mothers Mood Study’, which explored women's and midwives’ experience of mild to moderate perinatal mental health issues and service provision. Routinely collected population level data were analysed and a smaller cross-sectional survey design used to assess predictors of poor mental health in early pregnancy in one health board in Wales.\ud\udParticipants\udRoutinely collected data were extracted for all women who registered for maternity care between May 2017 and May 2018 (n = 6312) from the electronic maternity information system (pregnant population). Over a three month period 302 of these women completed a questionnaire at the antenatal clinic after an ultrasound scan (participants). Eligible women were aged ≥18 years, with sufficient spoken and written English to complete the questionnaire and a viable pregnancy of ≤18 weeks’ gestation. The questionnaire collected data on sociodemographic status, self-efficacy and support networks, self-reported mental health problems. Current anxiety and depression were assessed using the General Anxiety Disorders Assessment and Edinburgh Postnatal Depression Scale.\ud\udFindings\udAmong the pregnant population 23% (n = 1490) disclosed a mental health problem during routine questioning with anxiety and depression being the most common conditions. Participants completing the detailed questionnaire were similar in age and parity to the pregnant population with similar levels of depression (15.6%; n = 15.6 v 17.3%, n = 1092). Edinburgh Postnatal Depression Scale and General Anxiety Disorder 7 scores identified 8% with symptoms of anxiety (n = 25) or depression (n = 26) and a further 24.2% (n = 73) with symptoms of mild anxiety and 25.2% (n = 76) with mild depression. Low self-efficacy (OR 1.27, 95% CI 1.12–1.45), a previous mental health problem (OR 3.95, 95% CI 1.37–11.33) and low support from family (OR 1.13, 95% CI 1.00–1.27) were found to be associated with early pregnancy anxiety and/or depression.\ud\udKey conclusions and implications for practice\udAround one in five women who register for maternity care may have a mental health problem. Mild to moderate anxiety and depression are common in early pregnancy. Services need to improve for women who do not currently meet the threshold for referral to perinatal mental health services. Assessment and active monitoring of mental health is recommended, in particular for pregnant women with risk factors including a history of previous mental health difficulties, poor family support or low self-efficacy.

1. Nathan Donaldson, DO* 2. Julia Sanders, MD* 3. Jason Child, PharmD† 4. Sarah Parker, MD‡ 1. *Division of Orthopedic Surgery and 2. ‡Division of Infectious Diseases, Department of Pediatrics, University of Colorado Denver School of Medicine, Aurora, CO 3. †Department of Pharmacy, Children’s Hospital Colorado, Aurora, CO * Abbreviations: ADE: : adverse drug event CRMO: : chronic recurrent multifocal osteomyelitis CRP: : C-reactive protein CT: : computed tomography ESR: : erythrocyte sedimentation rate MRI: : magnetic resonance imaging MRSA: : methicillin-resistant Staphylococcus aureus MSSA: : methicillin-susceptible Staphylococcus aureus OAI: : osteoarticular infection WBC: : white blood cell Management of pediatric acute hematogenous osteoarticular infections has changed in various ways during the past decade, including the description of new pathogens and updated diagnostic and treatment strategies (such as infected source sampling and an early switch to oral therapy). After completing this article, readers should be able to: 1. Understand what predisposes children of different age groups to acute hematogenous osteoarticular infections (OAIs), particularly the role of anatomy and differing pathogenic susceptibilities. 2. Recognize the symptoms present in children with OAIs and their most common differential diagnoses. 3. Understand the most effective imaging techniques and laboratory tests/cultures to diagnose an OAI and how to interpret them. 4. Understand the benefits and limitations of therapeutic surgery and source sampling (biopsy/aspirate) and when to commence antimicrobial drug therapy. 5. Recognize the most common causative pathogens and the most effective antimicrobial drugs for their treatment. 6. Determine how long a patient should be taking intravenous and oral therapy and under what conditions they should switch from intravenous to oral antimicrobial agents. 7. Understand the recommended follow-up after diagnosis, including when to expect normalization of laboratory values in patients with uncomplicated OAIs. 8. Recognize complicated OAIs and their possible long-term sequelae. Pediatric osteoarticular infections (OAIs) include infections of the bones (osteomyelitis) and joints (septic arthritis). Pathogenic organisms may be introduced into these normally sterile sites via direct inoculation (eg, trauma or surgery) or via erosion from a contiguously infected source (eg, chronic ulcer), but organisms are mostly hematogenously delivered. Bacteria are the most common pathogens to cause OAIs, but mycobacteria, fungi, and viruses can also infect these tissues. If diagnosed in the first 10 to 14 days, these infections are …

Objective To identify the most cost‐effective policy for detection and management of fetal macrosomia in late‐stage pregnancy. Design Health economic simulation model. Setting All English NHS antenatal services. Population Nulliparous women in the third trimester treated within the UK NHS. Methods A health economic simulation model was used to compare long‐term maternal–fetal health and cost outcomes for two detection strategies (universal ultrasound scanning at approximately 36 weeks of gestation versus selective ultrasound scanning), combined with three management strategies (planned caesarean section versus induction of labour versus expectant management) of suspected fetal macrosomia. Probabilities, costs and health outcomes were taken from literature. Main outcome measures Expected costs to the NHS and quality‐adjusted life‐years (QALYs) gained from each strategy, calculation of net benefit and hence identification of most cost‐effective strategy. Results Compared with selective ultrasound, universal ultrasound increased QALYs by 0.0038 (95% CI 0.0012–0.0076), but also costs by £123.50 (95% CI 99.6–149.9). Overall, the health gains were too small to justify the cost increase given current UK thresholds cost‐effective policy was selective ultrasound coupled with induction of labour where macrosomia was suspected. Conclusions The most cost‐effective policy for detection and management of fetal macrosomia is selective ultrasound scanning coupled with induction of labour for all suspected cases of macrosomia. Universal ultrasound scanning for macrosomia in late‐stage pregnancy is not cost‐effective. Tweetable abstract Universal late‐pregnancy ultrasound screening for fetal macrosomia is not warranted., Tweetable abstract Universal late‐pregnancy ultrasound screening for fetal macrosomia is not warranted.

IntroductionThe 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 analysisWe 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 disseminationCHOICE 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 numberISRCTN32652461.

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.

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.

Background Women receive many public health messages relating to pregnancy which are intended to improve outcomes for babies and mothers. However, negotiating risk and the maternity system can feel confusing and dis-empowering. Relationships between women and their carers are central to maternity care trajectories but can be adversely affected by issues of trust and autonomy. Aim/Objectives To explore issues in the communication of pregnancy-related risk; to articulate women’s experiences and develop co-produced recommendations to improve pregnancy-related risk communication. Methods We used an online survey and qualitative interviews to gain an understanding of women’s experiences of advice, support, and decision making in pregnancy. The survey was disseminated through a Facebook advertisement inviting women 16–45 years across the UK to participate. Data was collected between June-August 2019. Survey participants were sampled to ensure the interview population included women whose voices are seldom heard and disproportionately impacted by poor risk communication. Data was collected between April-November 2019. Results Over 7,000 women completed the survey and 34 women then participated in interviews. 29% of the interview population were BAME and 29% received means-tested benefits. Many women initially implicitly trusted their healthcare providers (HCPs). However, partial advice from HCPs, particularly around medication, was a source of anxiety for women. Participants reported that the use of screening to ‘catch them out’ about smoking undermined their relationships with midwives. Several women living with obesity reported their data being shared with third parties, further undermining trust. Some reported lying to their midwives about their behaviours because they felt judged. Conclusions Our findings show the importance of risk communication that respects women’s autonomy and trusts them to make decisions about their own pregnancy. When trust breaks down some women may be more likely to hide their behaviour. Our research highlights a need to improve risk communication within maternity care.

Background: Women with obesity are at a greater risk of experiencing complications during the antenatal, intrapartum and postpartum periods. Despite many \ud studies of weight management interventions in pregnancy, systematic reviews have demonstrated limited effectiveness, demonstrating a need to increase the focus \ud on preconception health and build a greater awareness of the association between preconception health and maternal and child outcomes. Much of the research in \ud pre-conception weight loss has been with very specific populations or has been small-scale. The aim of the Plan-it study is to establish if it is acceptable and feasible \ud to conduct a study that asks women with overweight/ obesity (BMI of 25 or over) to delay removal of LARC to participate in a targeted pre-pregnancy weight loss \ud intervention. \ud Methods: The study will take a concurrent mixed methods approach incorporating use of routine NHS data and qualitative data collection and analysis across two \ud work-packages: the first will establish the feasibility of defining and understanding the population through routine data and the second will provide an understanding \ud of the feasibility and acceptability to stakeholders (LARC users and practitioners) of incorporating a pre-pregnancy weight loss intervention, in addition to identifying \ud potentially suitable weight loss interventions and the theories underpinning them. The findings from the two work packages will contribute to a final report, which \ud will delineate the key design elements of a future trial or identify the barriers that currently prevent such a trial taking place. \ud Discussion: The preconception period provides an opportunity to intervene with a weight loss intervention in women with overweight/ obesity. The findings of this \ud study will contribute to the evidence base for weight management in the preconception period and provides information, critical to consider, when developing a future \ud intervention and associated feasibility trial

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.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.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.We searched MEDLINE, EMBASE and the Cochrane Library from inception to June 2019.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.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.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.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.We describe proof-of-principle randomised controlled trials that could better inform the case for screening using ultrasound in late pregnancy.This study is registered as PROSPERO CRD42017064093.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inUltrasound scans allow doctors to check on the health of an unborn infant. Usually, all pregnant women receive a scan at about 3 months and about 5 months of pregnancy. After that, women are offered a scan during birth only if they have risk factors or if a problem develops. Problems can arise in the later stages of pregnancy, including issues with the infant’s growth or whether or not the infant is breech. Some of these problems may be prevented if a scan is carried out, but scans can also be inaccurate. When they are, a woman may receive unnecessary treatment, which could even harm her or her infant. In this study we set out to review previous research about how good ultrasound scanning is at detecting infants who may be born with a condition. This study focused on detecting if the infant was too big or too small. Unfortunately, much of the previous research was not carried out to a high standard. Scanning can detect the size of a infant relatively well, but it is much less clear if scanning can predict complications that may harm the infant during birth. We also studied the costs and outcomes of scanning. We calculated the extra cost required to scan every woman and compared this with the extra benefits from preventing complications. One thing that ultrasound scans detect is whether the infant is presenting head first or bottom first (a ‘breech presentation’), as infants presenting breech have high risks of complications. Scanning all women to check whether or not their infant is presenting breech seems to be cost-effective and the cost savings may even be higher than the cost of implementation, although this depends on how much the scan would cost. Whether or not it is worthwhile scanning all infants to see if they are above or below the thresholds for normal size is less clear. A larger research study could provide more reliable numbers from which to draw a conclusion. We show how such a study could be designed, so that a single study could tell us both how well scans can predict adverse outcomes and how helpful this information is.

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 [ISRCTN 13315580] 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 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 Disseminations: 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. Strengths and Limitations of the Study: • Using large retrospective and prospective datasets concomitantly provides six years’ data over a three-year study period. • Ability to look at all neonatal outcomes and treatments across the wide geographical range and number of units. • Using existing, routine data enhanced by prospective data to investigate the safety of waterbirth across a range of outcomes. • Data collected will only represent users of Wellbeing-Software’s EuroKing® maternity software system. • Allocation is not random, so unmeasured confounding is possible.

Objective: To evaluate caesarean section (CS) rates and moderate to severe hypoxaemic ischaemic encephalopathy (HIE) rates with other core intra-partum outcomes following reconfiguration of maternity services in Cardiff, South Wales, UK.\ud \ud Design: Cohort study of births from 2006 to 2015.\ud \ud Settings: A University tertiary referral centre for foetal and maternal medicine with 6000 births/year, University Hospital of Wales, United Kingdom.\ud \ud Method: Data relating to births from 1 January 2006 to 31 December 2015 were extracted from the computerized maternity database on a yearly basis. Case notes of all mothers and babies for the same duration were hand searched for documentation of HIE. HIE data was also collected prospectively by neonatologist (SC) and obstetrician (PA).\ud \ud Main outcome measures: Incidence of caesarean section births, babies with moderate to severe HIE, instrumental vaginal births, obstetric anal sphincter injuries (OASIS) associated with instrumental delivery, and major post-partum haemorrhage (MPPH) of 2500 mL or more.\ud \ud Results: During this 10-year period, a downward trend in emergency CS rate was seen from 15.6% in 2006 to 10.5% in 2015, reducing total CS rate from 25.5% in 2006 to 21.2% in 2015. A downward trend in the incidence of moderate and severe HIE was seen over the same period. There was an increase in operative vaginal births (OVB) from 12.8% to 15%. The rate of spontaneous vaginal births (SVB) remained stable. The incidence of OASIS remained constant and MPPH rate has fallen.\ud Conclusions: Following amalgamation of two medium sized obstetric units and the opening of a Midwifery Led Unit (MLU), core intrapartum outcomes have improved. Contributing factors are the introduction of regular multidisciplinary training with enhanced team working, compulsory education for obstetricians and midwives on cardiotocograph (CTG) interpretation, increased consultant presence on delivery suite, robust risk management systems and broad multidisciplinary agreement on clinical guidelines promoting vaginal birth.

Objective The COVID-19 pandemic saw universal, radical, and ultra-rapid changes to UK National Health Services (NHS) maternity care. At the onset of the pandemic, NHS maternity services were stripped of many of the features which support woman and family centred care. In anticipation of unknown numbers of pregnant women and maternity staff potentially sick with COVID-19, services were pared back to the minimum level considered to be required to keep women and their babies safe. The aim of this survey was to understand the impact of COVID-19 public health messaging and pandemic-related service changes on users of maternity care in the UK during the pandemic. Methods We conducted an online survey to explore user's experiences of COVID-19 public health messaging and ‘socially-distanced’ maternity care across the UK. The study population consisted of women who had experienced pregnancy after the 11th March 2020 (when the WHO declared a pandemic), whether or not they were still pregnant. We collected data between June and September 2020. We used framework analysis for the free-text data and generated descriptive statistics. Findings Women were generally happy to adopt a precautionary approach and stringently social distance in the context of a relatively unknown pathogen and in an environment of extreme anxiety and uncertainty, but were acutely aware of the negative impacts. The survey found that the widespread changes to services caused unintended negative consequences including essential clinical care being missed, confusion over advice, and distress and emotional trauma for women. COVID-19 restrictions have resulted in women feeling their antenatal and postnatal care to be inadequate and has also come at great emotional cost to users. Women reported feeling isolated and sad in the postnatal period, but also frustrated and upset by a lack of staff to help them care for their new baby. Key conclusions With growing evidence of the impact of the virus on pregnant women and an increased understanding of the unintended consequences of unclear public health messaging and overly precautious services, a more nuanced, evidence-based approach to caring for women during a pandemic must be prioritised. Implications for practice All maternity services should ensure they have clear lines of communication with women to keep them updated on changing care and visiting arrangements. Services should ensure that opportunities to provide safe face-to-face care and access for birth partners and visitors are maximised.

Abstract. Background: Perinatal stroke results in damage to the maturing brain and often leads to neurological deficits as well as mental and psychosocial impairments. This study identifies mental impairments emerging in preschool aged children following perinatal strokes. Methods: Scores on CBCL / 4-18 and CPM for 63 children following perinatal stroke were evaluated. Results: The study revealed a high incidence of behavioral disorders (39.7 %), especially on the CBCL subscales Social Problems and Attention Problems. Stroke type and involvement of the middle cerebral artery exerted the largest influence. A total of 48.3 % of the children exhibited below-average intelligence, though there was no significant correlation between intelligence and behavioral problems. Conclusion: In addition to cognitive and physical impairments, the psychological consequences of the disease must also be taken into account.

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.

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.

Objective\ud To identify factors influencing the use of birth pools.\ud \ud Design\ud Online discussion groups and semi-structured interviews, analysed thematically.\ud \ud Setting\ud United Kingdom.\ud \ud Participants\ud 85 women and 21 midwives took part in online discussion groups; 14 medical staff participated in interviews.\ud \ud Findings\ud Factors influencing the use of birth pools were grouped into three overarching categories: resources, unit culture and guidelines, and staff endorsement. Resources encompassed pool availability, efficiency of pool use and availability of waterproof cardiotocograph equipment. Unit culture and guidelines related to eligibility criteria for pool use, medicalisation of birth and differences between midwifery-led and obstetric-led care. Staff endorsement encompassed attitudes towards pool use.\ud \ud Key conclusions\ud Accessibility of birth pools was often limited by eligibility criteria. While midwifery-led units were generally supportive of pool use, obstetric-led units were described as an over-medicalised environment in which pool use was restricted and relied on maternal request.\ud \ud Implications for practice\ud Midwives can improve women's access to birth pools by providing information antenatally and proactively offering this as an option in labour. Maternity units should work to implement evidence-based guidelines on pool use, increase pool availability (even where there appears to be low demand), and enhance awareness amongst medical staff of the benefits of water immersion.

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 p = 0.046), poorer mental health (OR = 1.03 (CI = 1.01 to 1.05), p = 0.004), and being in the intervention arm of the trial (OR = 1.34 (CI = 1.07 to 1.70), p = 0.012). Conclusions Continuity between baseline and subsequent adverse experiences was expected despite potentially beneficial intervention impact. We hypothesise that excess events reported for intervention-arm participants is likely attributable to surveillance bias. We interpreted our findings against a new model that explicates processes that may drive event occurrence, presentation and reporting. Focussing only upon Medical events may miss the well-being and social circumstances that are important for interpreting intervention safety and participant management. Trial registration ISRCTN, ID: ISRCTN23019866. Registered on 20 April 2009.

BackgroundPOOL 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. AimWe 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. MethodsThe 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. ResultsThe 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)

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)

Background\ud \ud The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England.\ud \ud \ud Methods\ud \ud Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011–2012. Transcripts from audio-recordings were analysed thematically.\ud \ud \ud Results\ud \ud A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection.\ud \ud \ud Conclusion\ud \ud FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009.

Trauma to the labia occurs in up to 49% of vaginal births1. Trauma to the perineal body resulting from childbirth is well defined using widely used categories, and recommended management of perineal body trauma is based on high level evidence. Currently no similar evidence exists to inform the classification or management of labial trauma. This is reflected in variation in clinical practice with some practitioners favouring suturing of labial trauma, whilst others favour healing by secondary intention. A survey of practice was undertaken in three NHS organisations, over a five-week period in 2019 with data collected on 332 vaginal births. Overall, 47.3% (n=157) of women sustained labial trauma, of whom 29.3% (n=46) sustained trauma described as involving skin and underlying tissues. Of the labial trauma which involved skin and underlying tissues 76.0% (n=35) was sutured and the remainder unsutured. The survey confirmed a lack of consistency in practice and the need for further research to inform care for women.

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.

Background Only around 1% of babies in the UK are breastfed exclusively until six months of age as recommended by the World Health Organisation. One in ten women who have recently given birth in the UK have a long-term illness and they are at increased risk of stopping breastfeeding early. We considered women with autoimmune rheumatic diseases as an exemplar group of long term illnesses, to explore the barriers and enablers to breastfeeding Aim To understand the experiences of infant feeding among women with autoimmune rheumatic diseases and to identify potential barriers and enablers. Design Qualitative visual timeline-facilitated interviews. Participants and setting 128 women with autoimmune rheumatic diseases who were considering pregnancy, pregnant, or had young children took part in an online survey as part of the STAR Family Study. Of these, 13 women who had children were purposefully sampled to be interviewed. Interviews took place in person or on the telephone. Timeline-facilitated interviews were used to focus on lived experiences and topics important to the women, including early parenting. We conducted a focused thematic analysis of women's lived experiences of infant feeding. Results Three main themes were identified in relation to breastfeeding: lack of information about medication safety, lack of support in decision-making and maintaining breastfeeding, and maternal guilt. Conclusions Women with autoimmune rheumatic diseases found it difficult to access the information they needed about medications to make informed decisions about breastfeeding. They often also felt pressurised into breastfeeding and experienced feelings of guilt if they were unable, or did not wish to breastfeed. Tailored interventions are required that adopt a non-judgmental and person-centred approach to support decision-making in regard to infant feeding, providing women with information that can best enable them to make infant feeding choices.

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.

An uncontrolled study with process evaluation was conducted in three U.K. community maternity sites to establish the feasibility and acceptability of delivering a novel breastfeeding peer‐support intervention informed by motivational interviewing (MI; Mam‐Kind). Peer‐supporters were trained to deliver the Mam‐Kind intervention that provided intensive one‐to‐one peer‐support, including (a) antenatal contact, (b) face-to‐face contact within 48 hr of birth, (c) proactive (peer‐supporter led) alternate day contact for 2 weeks after birth, and (d) mother‐led contact for a further 6 weeks. Peer‐supporters completed structured diaries and audio‐recorded face‐to‐face sessions with mothers. Semi-structured interviews were conducted with a purposive sample of mothers, health professionals, and all peer‐supporters. Interview data were analysed thematically to assess intervention acceptability. Audio‐recorded peer‐support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool. Eight peer‐supporters delivered the Mam‐Kind intervention to 70 mothers in three National Health Service maternity services. Qualitative interviews with mothers (n = 28), peer‐supporters (n = 8), and health professionals (n = 12) indicated that the intervention was acceptable, and health professionals felt it could be integrated with existing services. There was high fidelity to intervention content; 93% of intervention objectives were met during sessions. However, peer‐supporters reported difficulties in adapting from an expert‐by‐experience role to a collaborative role. We have established the feasibility and acceptability of providing breastfeeding peer‐support using a MI‐informed approach. Refinement of the intervention is needed to further develop peer‐supporters' skills in providing mother‐centred support. The refined intervention should be tested for effectiveness in a randomised controlled trial.

Background: Motivational Interviewing (MI) is a person-centred counselling approach to behaviour change which is increasingly being used in public health settings, either as a stand-alone approach or in combination with other structured programmes of health promotion. One example of this is the Family Nurse Partnership (FNP) a licensed, preventative programme for first time mothers under the age of 20, delivered by specialist family nurses who are additionally trained in MI. The Building Blocks trial was an individually randomised controlled trial comparing effectiveness of Family Nurse Partnership when added to usual care compared to usual care alone within 18 sites in England. The aim of this process evaluation component of the trial is to determine the extent to which Motivational Interviewing skills taught to Family Nurse Partnership nurses were used in their home visits with clients. Methods: Between July 2010 and November 2011, 92 audio-recordings of nurse-client consultations were collected during the 'pregnancy' and 'infancy' phases of the FNP programme. They were analysed using The Motivational Interviewing Treatment Integrity (MITI) coding system. Results: A competent level of overall MI adherent practice according to the MITI criteria for 'global clinician ratings' was apparent in over 70 % of the consultations. However, on specific behaviours and the MITI-derived practitioner competency variables, there was a large variation in the percentage of recordings in which "beginner proficiency" levels in MI (as defined by the MITI criteria) was achieved, ranging from 73.9 % for the 'MI adherent behaviour' variable in the pregnancy phase to 6.7 % for 'percentage of questions coded as open' in the infancy phase. Conclusions: The results suggest that it is possible to deliver a structured programme in an MI-consistent way. However, some of the behaviours regarded as key to MI practice such as the percentage of questions coded as open can be more difficult to achieve in such a context. This is an important consideration for those involved in designing effective structured interventions with an MI-informed approach and wanting to maintain fidelity to both MI and the structured programme. Trial registration: Current Controlled Trials ISRCTN23019866Registered 20/4/2009.

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 (

Introduction Reducing smoking in pregnancy was a primary outcome in our Building Blocks trial of the Family Nurse Partnership. We calibrated maternal reports of smoking using cotinine values derived from urine samples to assess tobacco use. This involves identifying the extent to which an individual accurately reports smoking and requires complete and synchronized data collection over time. However, some urine samples may be missed or collected at a different time from self-report (non-synchronized Methods We used statistical validation processes to address both non-synchronized and incomplete data. First, we examined consistency in reporting behaviors at baseline and follow-up for participants grouped by extent of non-synchronized time of collection. Second, we used data from complete cases to infer values for mothers with missing urine samples at follow-up. We then used Markov chain transition rate matrix constructed to assess the robustness of such inferences. Results Maternal underreporting and overreporting of smoking were consistent across the 870 participants grouped by different levels of noncontemporary data collection (Breslow-Day test: p = .24; chi-square test: p = .69). Using participants’ baseline reporting behaviors to infer their follow-ups provided comparable smoking outcomes (4.5 cigarettes/day with SD of 5.5) to the simulated counterparts (4.5 cigarettes/day with SD of 6.0). Conclusion We have demonstrated consistent reporting behavior over time and minimal impact due to nonaligned follow-up urine sample collection. For studies collecting smoking data, this proposed method provided a pragmatic solution to facilitate the calibration process of self-reported tobacco use and retain adequate power without introducing undue bias. Implications Synchronized and completed data collection is essential but very often hard to achieve in smoking related studies. When violated, proper statistical validation process should be followed to minimize the potential bias and loss of power in trial analyses. For this purpose, we provided the Building Block trial as an example to demonstrate how to deal with the non-synchronization and incompleteness issues in data collection.

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.

Objectives We compared the US-derived Family Nurse Partnership (FNP) home visiting programme when added to usually provided health and social care for first-time teenage mothers, to usual care alone. We aimed to: establish the nature of usual care, measure service usage and assess performance bias in core usual care services. Design Within trial process evaluation. Local professionals completed a survey mapping local health and social care services in seven domains. This focused on services available to young women, especially those relevant to pregnant teenagers. Descriptive data were assessed thematically to establish the range of services. Quantitative data collection with FNP supervisors enumerated service provision by site. Services identified were included in main participant trial follow-up interviews at four time points to quantify usage. Usage was described descriptively by domain. We explored predictors of health visitor visits. Setting 18 partnerships of local authority and healthcare organisations in England. Outcomes Descriptive framework of services. Rates of service usage reported by trial participants. Results 161 separate services were identified, with multiple service models in each domain, broadly categorised as universal or specialist (eg, for teenage mothers). FNP supervisors identified 30–63 universal services per site and 22–67 specialist services. Use of core maternity care services was similar across trial arms and with only small differences in use of health visiting services. Participants accessed a wide range of services. Women who had ever been homeless, who had a higher subjectively defined social status, and poorer mental health received more visits from a health visitor. Conclusions The large number of services available to teenage mothers in England may limit the incremental benefit achievable through enhanced home visiting. There was little evidence of compensatory practice, such as additional care for women in the usual care arm. Measuring usual care when trialling complex interventions is challenging and essential. Trial registration number NCT23019866.