What are the experiences of pregnancy for women living with Inflammatory Bowel Disease?

BACKGROUND: Inflammatory Bowel Disease (IBD) is a long-term condition affecting the digestive tract and is an umbrella term for two main conditions: ulcerative colitis (UC) and Crohn's Disease (CD), which can cause diarrhoea, anaemia, weight loss, rectal bleeding and abdominal pain. Approximately 500,000 people live with IBD in the UK, with half being diagnosed before the age of 35 years (Ferguson, Mahsud-Dornan, and Patterson 2008). IBD increases the risk of pregnancy complications, with symptoms being unpredictable during pregnancy. METHODS: A mixed methods study was undertaken exploring what shaped the experiences of pregnancy for women living with IBD, including an on-line survey and one-to-one interviews. Data from the interviews were analysed using Interpretative Phenomenological Analysis. FINDINGS: Expectations, control and care emerged as key themes which shape the experiences of pregnancy. These included expectations about pregnancy and of those providing care during pregnancy, the positive and negative impact of experienced lack of control and the effects of primary care providers during pregnancy. CONCLUSION: This novel study enabled women living with IBD to share what shaped their experiences of pregnancy and recommendations about midwifery care to be made. Midwives need to be mindful of the additional risks for women and their babies, and ensure care involves multidisciplinary specialists.

RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth.

BACKGROUND: Perinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive negative thinking (RNT)-such as worrying about ways things will go wrong in the future or ruminating about past negative events-is a risk factor for the development of anxiety. RNT is maintained by the tendency to generate negative interpretations of ambiguous situations. METHODS: A parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. Participants (N = 268) will be randomised to (i) 12 sessions of online interpretation training (RELAX) plus usual care, or (ii) usual care alone. We will assess anxiety, depression, RNT, and work and social adjustment at baseline, plus 4, 8 and 36 weeks later. DISCUSSION: Should the intervention result in lower levels of anxiety than usual care, it could be an accessible, cost-effective way to help women who are vulnerable to experiencing anxiety in the perinatal period. TRIAL REGISTRATION: ISRCTN 12754931. Registered 25th May 2023, prior to recruitment.

Content and timing of the 6-8 week maternal postnatal check: a mixed methods study.

BACKGROUND: Since 2020, the General Medical Services contract requires GP practices in England to offer women a GP appointment 6-8 weeks after birth: the '6-8 week postnatal check' or 'consultation'. Historically, provision of checks was variable, and women still frequently report poor experiences. AIM: To explore GPs' and women's perspectives of the 6-8 week postnatal check, including key components and timing. DESIGN & SETTING: Mixed methods study: focus groups of GPs and women, and an online survey of GPs in England. METHOD: Focus groups explored GPs' and women's experiences of postnatal consultations. An online survey explored GPs' clinical approach, organisation, and improvement potential. Quantitative analysis examined associations between demographics and clinical approach. Thematic framework analysis was used for qualitative data. RESULTS: 18 women and 14 GPs participated in focus groups. 671 GPs completed the survey. Mental wellbeing and contraception were reported as important topics, although some women were not asked about mental health. GP survey responses indicated most recommendations from national guidance were 'always' or 'very often' covered by most, but not all GPs. Clinical coverage was higher for GPs who used clinical templates, had awareness of guidance, were female or a parent. Many GPs (n=326, 49%) needed more time than was allocated for the consultation: (n=524, 78% allocated<15 minutes; n=351, 52% completed in<15 minutes). CONCLUSION: This study suggests GPs are allocated insufficient time for postnatal consultations, with substantial variation in practice. Specifying consultation duration and consideration of template usage in policy may improve care and outcomes for women.

Preconception health among migrant women in England: A cross-sectional analysis of maternity services data 2018-2019.

Background: Perinatal outcomes are poor among migrant women in vulnerable situations, but little is known about their health preconception. We investigated preconception health inequalities between migrant women in vulnerable situations and non-migrant women. Methods: This national cross-sectional study used data from the NHS Maternity Services Data Set (MSDS) version 1.5, incorporating NHS maternity services in England. All 652,880 women with an antenatal booking appointment between 1/4/2018 and 31/3/2019 were included. Migration category data were available for 66.2 % (n = 432,022). Odds ratios were calculated comparing preconception indicators among probable migrants in vulnerable situations (English not their first language with complex social factors (CSF)), probable migrants not in vulnerable situations (English not their first language without CSF), probable non-migrants in vulnerable situations (English their first language with CSF) and probable non-migrants not in vulnerable situations (English their first language without CSF). CSF include recent migrants, asylum seekers, refugees, difficulty reading/speaking English; alcohol and/or drugs misuse; aged under 20; and/or experiencing domestic abuse. Findings: We identified 3.8 % (25,070 women) of the study population as probable migrants in vulnerable situations, 10.2 % (66,783 women) as probable migrants not in vulnerable situations, 5.6 % (36,433 women) as probable non-migrants in vulnerable situations, 46.5 % (303,737 women) as probable non-migrants not in vulnerable situations, and 33.8 % as having missing migration category data. Probable migrants in vulnerable situations (n = 25,070) had over twice the odds of not taking folic acid preconception compared to probable non-migrants not in vulnerable situations (odds ratio 2.15, 95 % confidence interval 2.06-2.25). They had increased odds of previous obstetric complications and being underweight, but lower odds of physical and mental health conditions (apart from diabetes and hepatitis b), smoking and overweight or obesity. Interpretation: Inequalities exist across many preconception indicators, highlighting opportunities to improve preconception health in this population to reduce health inequalities and improve perinatal and neonatal outcomes. Funding: Medical Research Council.

Evidence for the clinical effectiveness of decongestive lymphoedema treatment for breast cancer-related arm lymphoedema, a systematic review.

PURPOSE: Early treatment is advised for breast cancer-related arm lymphoedema (BCRL), a common sequelae of breast cancer treatment. Expert guidance recommends two-phase decongestive lymphoedema treatment (DLT), although evidence is lacking for current treatment protocols and UK women are routinely offered self-treatment with hosiery. This systematic review considered evidence regarding treatment of early BCRL, that is, within 12 months of developing BCRL. METHODS: A systematic review of evidence for clinical effectiveness of DLT for women with less than 12-month BCRL duration (early BCRL) was undertaken using the Joanna Briggs Institute (JBI) method. Studies included women with < 12-month or mean < 9-month BCRL duration; some studies reported only one eligible group. The original search was conducted in 2016 and updated in 2018 and 2022. Methodological quality of identified studies was assessed using JBI critical appraisal instruments. Outcomes of interest were extracted with eligible results displayed in narrative and tabular format. Strength of evidence was rated using the GRADE system. RESULTS: Seven trials and three descriptive studies provided weak evidence (grade B) for effectiveness of DLT for early BCRL. Heterogeneous protocols limited comparison of findings. There was no evidence for the most effective treatment or treatment combination or optimal frequency or duration of treatment. CONCLUSION: There is no evidence to justify change in current lymphoedema treatment, whether self-treatment with hosiery (UK) or two-phase DLT (other countries). Further research for the early BCRL population is required. IMPLICATIONS FOR CANCER SURVIVORS: Women with early BCRL require early and effective treatment although this updated review shows there is still no evidence for what that treatment should be.

Effectiveness of a home-based peer support programme for Chinese mothers with low breastfeeding self-efficacy to increase the exclusivity and duration of breastfeeding: study protocol of a randomised control trial.

INTRODUCTION: Breastfeeding is associated with many health benefits for both women and their newborns. Exclusive breastfeeding has been recommended for at least 6 months to optimise infant growth, development and health. In addition to standard care, community-based peer support is recommended to help mothers improve breastfeeding. A recent survey reveals that the rate of exclusive breastfeeding at 6 months post partum in Hong Kong is low, and half of all breastfeeding mothers never exclusively breastfeed. Taking into account the local practice for women to stay home during the first month post partum and social isolation during and post-COVID-19 pandemic, a home-based peer support programme with the aid of Zoom or Facetime is proposed. This study aims to evaluate the effectiveness of a home-based breastfeeding peer support programme in improving breastfeeding practices and achieving exclusive breastfeeding rate among women with low breastfeeding self-efficacy. METHODS AND ANALYSIS: The study is a two-armed randomised control trial and will include a total of 442 participants. Potential cases will be recruited and screened at four postnatal wards in Hong Kong public hospital. Eligible and consented cases will be randomly allocated into intervention or control groups at a 1:1 ratio. Control group (n=221) will receive standard care, while the intervention group (n=221) will receive home-based peer support as well as standard care. Trained peer counsellors will provide breastfeeding-related support through Zoom or Facetime at 10 days and 1 month post partum. Telephone follow-ups will be conducted at 1 month, 2 months, 3 months and 6 months post partum. Breastfeeding status, mother's breastfeeding self-efficacy and postpartum depression will be assessed and compared between the two arms. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Institutional Review Board of the University of Hong Kong and Hospital Authority Hong Kong West Cluster (UW 20-564). The findings will be updated in trial registries and disseminated in peer-reviewed journals and academic conferences. TRIAL REGISTRATION NUMBER: NCT04621266.

GP's role in supporting women with anal incontinence after childbirth injury: a qualitative study.

BACKGROUND: Obstetric anal sphincter injury is the most common cause of anal incontinence for women, which often has profound impacts on women's lives. GPs offer a first line of contact for many women, but we know that very few women experiencing anal incontinence postnatally report discussing it with their GPs. AIM: To identify key ways in which GPs can support women with anal incontinence caused by childbirth injuries. DESIGN AND SETTING: A qualitative study investigating women's experiences with their GP, and GPs' perspectives about providing such care. METHOD: This qualitative study combined two phases: first, a series of in-depth semi-structured interviews with women experiencing anal incontinence caused by childbirth injuries (n = 41); and second, focus groups with GPs (n = 13) stratified by experience. Thematic analysis was conducted and relevant themes from across the two datasets were examined. RESULTS: Mediating factors in GP care for women with anal incontinence caused by childbirth injuries centred around three key themes: the role of the GP, access and pathways, and communication. CONCLUSION: The findings demonstrate multifactorial challenges in identifying the problem and supporting women experiencing anal incontinence after childbirth injury in primary care settings. Many GPs lacked confidence in their role in supporting women, and women were often reluctant to seek help. Those women who did seek help often experienced frustrations consulting with their GPs. In a context where women are often reluctant to ask for help, their concerns are not always taken seriously, and where GPs do not routinely ask about anal incontinence, potential anal incontinence after childbirth injury appears to be often missed in a primary care setting.

Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol.

INTRODUCTION: The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot. METHODS AND ANALYSIS: This study will comprise a multicentre, double-blinded, randomised, placebo-controlled trial in at least 50 UK obstetric units. The target population is 1552 women with a twin pregnancy and a planned birth between 35 and 38+6 weeks' gestation recruited from antenatal clinics. Women will be randomised to Dexamethasone Phosphate (24 mg) or saline administered via two intramuscular injections 24 hours apart, 24-120 hours prior to scheduled birth. OUTCOMES: The primary outcome is need for respiratory support within 72 hours of birth. Secondary and safety outcomes will be included. Cognitive and language development at age 2 years will be assessed in a subset of participants using the Parent report of Children's Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo. ETHICS AND DISSEMINATION: STOPPIT-3 has been funded and approved by the National Institute of Healthcare Research. It has been approved by the West Midlands Research Ethics Committee (22/WM/0018). The results will be disseminated via publication in peer-reviewed journals and conference presentation and will also be communicated to the public via links with charity partners and social media. TRIAL SPONSOR: The University of Edinburgh and Lothian Health Board ACCORD, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ. TRIAL REGISTRATION NUMBER: ISRCTN59959611.

Lived experience of recurrent miscarriage: women and their partners' experience of subsequent pregnancy and support within an NHS specialist clinic - a qualitative study.

OBJECTIVE: This study aims to describe the lived experiences of couples with a history of recurrent miscarriage in subsequent pregnancies and their perception of clinic support and cytogenetic investigations. DESIGN: A qualitative interview study with a phenomenological approach. Semistructured interviews were conducted using video conferencing software. Two researchers coded the transcripts and developed themes. SETTING: A National Health Service (NHS) hospital in central England between May 2021 and July 2021, during the COVID-19 pandemic. PARTICIPANTS: Patients attending a specialist recurrent miscarriage clinic and their partners. This clinic accepts referrals from all over the UK for couples who have suffered two or more miscarriages. RESULTS: Seventeen participants were interviewed: 14 women and 3 male partners. Six main themes were identified from the data. Three related to the women's lived experience of recurrent miscarriage (emotions in pregnancy, confidence in their bodies, expectations and coping strategies) and three related to the clinical support offered by the NHS service (impact of early pregnancy scanning, effect of the COVID-19 pandemic and cytogenetic investigations). CONCLUSIONS: Pregnancy following recurrent miscarriage is extremely difficult. Recurrent miscarriage specialist services can provide couples with support and access to early pregnancy scanning, which can make the first trimester of pregnancy manageable. Partners should not be excluded from the clinic as it can result in a feeling of disconnect. Cytogenetic testing of pregnancy tissue can offer couples with recurrent miscarriage closure after pregnancy loss and is a desired investigation.

Designing economic evaluations alongside clinical trials in maternal health care: A guide for clinical trial design.

BACKGROUND: Economic evaluations are being conducted with increasing frequency in the maternity care setting, with more randomized controlled trials containing a health economic component. Key emerging criticisms of economic evaluation in maternity care are lack of robust data collection and measurement, inconsistencies in methodology, and lack of adherence to reporting guidelines. METHODS: This article provides a guide to the design of economic evaluations alongside clinical trials in maternal health. We include economic concepts and considerations for the maternity setting and provide examples from the UK and Australia. RESULTS: There are many important considerations for the design of economic evaluations alongside clinical trials. To be effective, researchers must select types of economic evaluation, which align with their study objectives; choose an appropriate evaluation perspective, time horizon, and discount rate; and identify accurate ways to measure and evaluate health outcomes and costs. DISCUSSION: This guide is written for noneconomists and can be used for designing economic evaluations to be conducted as a part of clinical trials. We seek to improve the quality, consistency, and transparency of economic evaluations in maternal health.

A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA).

BACKGROUND: Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities. METHODS: The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. DISCUSSION: This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice. TRIAL REGISTRATION: EudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.

Women's experiences of anal incontinence following vaginal birth: A qualitative study of missed opportunities in routine care contacts.

OBJECTIVES: This study aimed to explore experiences of women with anal incontinence following a childbirth injury, and to identify areas of missed opportunities within care they received. DESIGN: This is a qualitative study involving semi-structured interviews. SETTING: Participants were recruited via five hospitals in the UK, and via social media adverts and communication from charity organisations. PARTICIPANTS: Women who have experienced anal incontinence following a childbirth injury, either within 7 years of sustaining the injury, or if they identified new, or worsening symptoms of AI at the time of menopause. MAIN OUTCOME MEASURES: Main outcomes are experiences of women with anal incontinence following childbirth injury, and missed opportunities within the care they received. RESULTS: The following main themes were identified: opportunities for diagnosis missed, missed opportunities for information sharing and continuity and timeliness of care. CONCLUSIONS: Anal Incontinence following a childbirth injury has a profound impact on women. Lack of information and awareness both amongst women and healthcare professionals contributes to delays in accurate diagnosis and appropriate treatment.

A mixed methods systematic review exploring infant feeding experiences and support in women with severe mental illness.

There are many benefits of breastfeeding to women and their infants but meeting the recommended 6 months of exclusive breastfeeding is likely to be more challenging for women with severe mental illness (SMI). This is the first systematic review that aims to examine evidence of (a) infant feeding outcomes in women with SMI and the factors associated with this, (b) the experiences of infant feeding and infant feeding support for women with SMI, (c) interventions for supporting infant feeding among these women and (d) health care professionals' attitudes toward supporting infant feeding in women with SMI. Mixed methods systematic review was carried out using the principles of Joanna Briggs Institute's (JBI) 'convergent integrated' methodology. CINAHL, PsycINFO, Medline and MIDIRS were used to search literature between 1994 and 2022. The quality of selected articles was assessed using JBI critical appraisal tools and thematic synthesis was undertaken to obtain findings. Eighteen papers were included in the final review. Women with SMI were less likely to initiate and continue breastfeeding than women without SMI. Several challenges with breastfeeding were highlighted, and while these were often linked to women's mental health difficulties, inconsistent advice from health care professionals and poor support with breastfeeding further compounded these challenges. This review highlights that policy and practice need to take into account the individual challenges women with SMI face when planning, initiating and maintaining breastfeeding. Education and training for health care professionals are needed to enable them to provide tailored infant feeding support to women with SMI, which reflects their individual needs.

Interventions to enhance pre-pregnancy care for women with type 2 diabetes: A systematic review of the literature.

AIMS: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre-pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. METHODS: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre-pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full-text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta-analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. RESULTS: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%-40%) and none of the interventions were exclusively tailored for them. The uptake of pre-pregnancy care was lower in women with type 2 diabetes (8%-10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre-pregnancy care, with varying impact on pregnancy outcomes. CONCLUSIONS: This review demonstrates that previous interventions have had a limited impact on pre-pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre-pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities.

Qualitative systematic review of general practitioners' (GPs') views and experiences of providing postnatal care.

OBJECTIVES: Develop an understanding of the views and experiences of general practitioners (GPs) about their role in postnatal care, including barriers and facilitators to good care, and timing and content of planned postnatal checks. DESIGN: Qualitative systematic review. DATA SOURCES: Electronic database searches of MEDLINE, EMBASE, CINAHL, PubMed, Web of Science, PsychINFO from January 1990 to September 2021. Grey literature and guideline references from National Institute of Health and Care Excellence, WHO, International Federation of Gynecology and Obstetrics, Royal College of General Practitioners, Royal College of Obstetrics and Gynaecology. INCLUSION CRITERIA: Papers reporting qualitative data on views and experiences of GPs about postnatal care, including discrete clinical conditions in the postnatal period. Papers were screened independently by two reviewers and disputes resolved by a third reviewer. QUALITY APPRAISAL: The Critical Appraisal Skills Programme checklist was used to appraise studies. DATA EXTRACTION AND SYNTHESIS: Thematic synthesis involving line-by-line coding, generation of descriptive then analytical themes was conducted by the review team. The Capability, Opportunity, Motivation-Behaviour (COM-B) model was used to develop analytical themes. RESULTS: 20 reports from 18 studies met inclusion criteria. Studies were published from 2008 to 2021, reporting on 469 GPs. 13 were from UK or Australia. Some also reported views of non-GP participants. The clinical focus of studies varied, for example: perinatal mental health, postnatal contraception. Five themes were generated, four mapped to COM-B: psychological capability, physical opportunity, social opportunity and motivation. One theme was separate from the COM-B model: content and timing of postnatal checks. Strong influences were in physical and social opportunity, with time and organisation of services being heavily represented. These factors sometimes influenced findings in the motivation theme. CONCLUSIONS: GPs perceived their role in postnatal care as a positive opportunity for relationship building and health promotion. Addressing organisational barriers could impact positively on GPs' motivation to provide the best care. PROSPERO REGISTRATION NUMBER: 268982.

A longitudinal qualitative study of women's experiences of postnatal care following hypertensive disorders of pregnancy.

PROBLEM: There has been little focus on women's views of care and recovery following pregnancy complicated by hypertensive disorders of pregnancy [HDP] despite long-term implications for maternal health. BACKGROUND: Increasingly in clinical research, areas of interest include the extent to which women are involved in postnatal care planning, perceived value of routine postnatal contacts, lifestyle behaviour advice, and extent to which ongoing concerns about HDP could be discussed with healthcare professionals. AIM: This study explored women's experiences of birth-recovery up to 12 months following HDP. METHODS: A longitudinal qualitative study using semi-structured interviews at four and 12 months postpartum. Twenty-four women who each had a form of HDP, were recruited using a maximum variation, purposive sampling strategy from four National Health Service maternity units in London, 21 of whom were interviewed at both time points. Data were collected and analysed by timepoint following a recurrent, cross-sectional cohort approach using template analysis methodology. FINDINGS: Four main themes and ten sub-themes were identified. Main themes included: assumptions about blood pressure; perinatal experiences; postnatal care pathways; and managing complex health conditions. DISCUSSION: Postnatal care needs to be tailored to women's individual needs following HDP, with ongoing review by relevant clinicians during and beyond the first six weeks. Many women with HDP have ongoing information needs about hypertensive status, treatment and prognoses, and future birth planning. CONCLUSION: Policy makers, health providers and funders cannot continue to ignore the need to ensure postnatal services meet the needs of women who have experienced medically complex pregnancies.

Easier, but not easy: Testing a grounded theory of breastfeeding experiences among women with larger birthweight infants.

OBJECTIVE: Grounded Theory has previously been used to explore breastfeeding practices amongst average birthweight infants and these working hypotheses can be 'tested' in new contexts. A pre-existing Grounded Theory was applied to the context of women who gave birth to larger birthweight infants (≥4,000 g) to understand whether perceptions and practices of infant feeding were distinct. DESIGN: A nested qualitative study analysed data from N = 10 women with a larger birthweight infant (≥4,000 g). Face-to-face, semi-structured interviews were audio-recorded and transcribed verbatim. Grounded Theory methodology was used to analyse data. RESULTS: A pre-existing Grounded Theory of breastfeeding experiences derived from women with average birthweight infants did not hold true among women with larger birthweight infants. An alternative Grounded Theory was therefore proposed comprised of three discrete themes: Infant Ability to Breastfeed; Attenuating Maternal Concerns; and Reality of Breastfeeding. CONCLUSIONS: Larger infant birthweight is potentially a protective factor against breastfeeding latch and lactation difficulties. It is associated with alleviating maternal concerns, helping to reduce disparities between expectations of breastfeeding and reality, but does not alleviate the demands breastfeeding places on women. Healthcare professionals help to attenuate women's concerns, however the support needs for women with larger birthweight infants may not differ from existing care recommendations.

Induction of labour for predicted macrosomia: study protocol for the 'Big Baby' randomised controlled trial.

INTRODUCTION: Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0-38+4 weeks' gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia. METHODS AND ANALYSIS: The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks' gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks' gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included. ETHICS AND DISSEMINATION: The study received a favourable opinion from the South West-Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN18229892.

A feasibility randomised controlled trial with an embedded qualitative evaluation of perinatal emotional skills groups for women with borderline personality disorder: protocol for the EASE study.

BACKGROUND: Borderline personality disorder (BPD) is a severe mental disorder characterised by emotional instability, impaired interpersonal functioning and an increased risk of suicide. There is no clear evidence about how best to help women with BPD during the perinatal period. Perinatal Emotional Skills Groups (ESGs) consist of 12 group sessions, focussing on core skills in emotion regulation, interpersonal effectiveness, distress tolerance and mindfulness and how these skills can best be utilised during the perinatal period. Prior observational research has shown that perinatal ESGs may help women with BPD. We set out to test the feasibility of conducting a randomised controlled trial to investigate the clinical effectiveness of perinatal ESGs. METHODS: A two-arm, parallel-group, feasibility randomised controlled trial of Perinatal ESGs in addition to Treatment as Usual (TAU) versus TAU for women aged over 18 years, who are likely to have a diagnosis of BPD and are either pregnant or are within 12 months of having a live birth. We will exclude women who have a co-existing organic, psychotic mental disorder or substance use dependence syndrome; those with cognitive or language difficulties that would preclude them from consenting or participating in study procedures; those judged to pose an acute risk to their baby and those requiring admission to a mother and baby unit. After consenting to participation and completing screening assessments, eligible individuals will be randomly allocated, on a 1:1 ratio, to either ESGs + TAU or to TAU. Randomisation will be stratified according to recruitment centre. Feasibility outcomes will be the proportion of participants: (1) consenting; (2) completing baseline measures and randomised; (3) completing the intervention and (4) completing follow-up assessments. All study participants will complete a battery of self-report measures at 2 and 4 months post-randomisation. A nested qualitative study will examine participants' and therapists' experiences of the trial and the intervention. DISCUSSION: Evidence is lacking about how to help women with BPD during the perinatal period. Perinatal ESGs are a promising intervention and if they prove to be an effective adjunct to usual care, a large population of vulnerable women and their children could experience substantial health gains. TRIAL REGISTRATION: ISRCTN80470632.