OBJECTIVE:To assess the effect of a proactive, assets based, peer support infant feeding intervention in addition to usual care on breastfeeding rates, formula feeding practices, and other outcomes, compared with usual breastfeeding support alone. DESIGN:UK based, multicentre, parallel group, unblinded, randomised controlled trial. SETTING:17 localities in the UK that offered breastfeeding peer support as part of usual care between January 2022 and 30 April 2024. PARTICIPANTS:2475 nulliparous women between 20 and 35 weeks of gestation were randomised 1.43:1, to account for potential clustering by peer supporter: 1458 to the ABA-feed (Assets based feeding help Before and After birth-feed) peer support intervention and 1017 to usual care. INTERVENTIONS:The ABA-feed intervention comprised person centred proactive peer support for infant feeding underpinned by an assets based approach (focusing on the capabilities of, and resources available to, participants) and behaviour change theory delivered in person and remotely by text and telephone call. Usual care included universal care from midwives and health visitors and could also include services that provided reactive support such as peer supporters in breastfeeding groups, counselling, helplines, and social media support groups. MAIN OUTCOME MEASURES:The primary outcome was any breastfeeding at eight weeks after birth. Secondary outcomes at eight, 16, and 24 weeks after birth included breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support, and healthcare utilisation. Analyses were based on the intention-to-treat principle. RESULTS:Rates of any breastfeeding at eight weeks did not differ between the intervention group (1013/1452; 69.8%) and usual care group (698/1015; 68.8%); adjusted risk difference 0.01, 95% confidence interval -0.03 to 0.04. Preplanned subgroup analyses showed no interactions between the intervention and age, prespecified feeding intentions, mother's education, index of multiple deprivation fifth, or relationship status. Breastfeeding initiation rates were high (intervention 94.2%; usual care 92.5%). At eight weeks the intervention group reported higher social support, but this was not sustained at 16 weeks. No differences were observed in other secondary outcomes. CONCLUSION:The ABA-feed peer support intervention did not improve breastfeeding rates compared with usual breastfeeding support in a UK context. TRIAL REGISTRATION:ISRCTN Registry ISRCTN17395671.

PROBLEM:Infant readmissions within the first 28 days of life have risen significantly over the past decade. BACKGROUND:Postnatal care is often described as under-resourced, with many women reporting a lack of sufficient support after birth. OBJECTIVE:To explore parents' experiences in the lead-up to infant readmission within the first four weeks of life. METHODS:Twenty-eight parents of 18 infants unexpectedly admitted to a large urban paediatric referral hospital in England within four weeks of birth were interviewed face to face. Data were analysed using thematic analysis. FINDINGS:Parents valued being united in their role as protectors. Mothers struggling with breastfeeding often felt intense responsibility, being their baby's sole source of nutrition. When concerns arose, some parents were unsure who to contact. Seeking advice from family sometimes delayed professional help. Others felt dismissed by health professionals offering false reassurance. Many were comforted upon arriving at the hospital and receiving a diagnosis, which validated their concerns and reinforced their protective instincts. DISCUSSION:This study highlights parents' need to be together post-birth, their decision-making when their baby became unwell, and their interactions with health professionals during readmission. CONCLUSION:Services should support shared caregiving early on by improving partner access to postnatal wards and enhancing community support for families returning home. The care pathway for unwell infants is often unclear and should be made more accessible to avoid unnecessary emergency visits. Health professionals must prioritise women's emotional wellbeing, especially during breastfeeding challenges, and respond seriously to parental concerns with clear escalation routes.

INTRODUCTION:Pregnant women who use specialist perinatal mental health services are more likely to be smokers at the time of birth than those without mental illness. This study explored health professionals' experiences of providing smoking cessation support to pregnant women with complex and severe mental illness. METHODS:Online video semi-structured interviews were conducted in England October 2023 - October 2024 with 20 National Health Service (NHS) healthcare professionals whose role included discussing smoking cessation with pregnant women with mental illness. Using job descriptions, participants were categorised 'signposters' (n= 11) or 'stop smoking practitioners (SSP)' (n=9). Interview topic guides and data analysis were guided by the Theoretical Domains Framework. RESULTS:Reported barriers to effective provision of smoking cessation support included prioritising mental health over smoking cessation and being cautious about communicating harms of smoking in case it caused women's mental health to deteriorate. Health professionals also lacked confidence that pregnant women with mental illness could quit. Lacking knowledge about the relationship between mental health and smoking was a barrier specifically for many 'signposters'. Facilitators included having capacity for health professionals to be responsive to women's needs, offering flexibility and effective integration of smoking cessation services within maternity and mental health care settings. CONCLUSIONS:Barriers to effective smoking cessation support included prioritising mental illness over smoking cessation advice and a pessimistic view that pregnant women with mental illness would struggle to quit smoking. Facilitators included full integration of services and adapting to women's needs by offering flexible timing and delivery of smoking cessation support.ImplicationsThis study shows multiple areas which may be impacting on the effectiveness of smoking cessation support available to pregnant women with mental illness. Future research could address some of the barriers identified in the study including prioritising mental health over smoking cessation, addressing health professionals' beliefs that pregnant women with mental illness are unlikely to quit smoking, training on communicating harms of smoking and improving knowledge on effect of smoking on mental health. Future research could also focus on sharing good practice including appointment flexibility and full integration of smoking cessation services within maternity and perinatal mental health services.

Smoking during pregnancy is the leading preventable cause of maternal and infant morbidity and mortality in high income countries, disproportionately affecting women with mental illness. While behavioural smoking cessation interventions are effective for pregnant women and non-pregnant people with mental illness separately, evidence for specific smoking cessation interventions for pregnant women with mental illness is lacking. This review aimed to identify and map BCTs from effective general mental health smoking cessation trials to determine which may be helpful for pregnant women experiencing mental illness. A systematic review identified effective smoking cessation RCTs among people with mental illness. MEDLINE, EMBASE, PsycINFO, CINAHL, HMIC and CENTRAL databases were searched through April 2026. BCTs were coded using BCT Taxonomy; those in at least two effective interventions classified as ‘promising’ and compared against BCTs identified within National Centre for Smoking Cessation Training Standard Treatment Programme for pregnant women. Of 12,403 records, 195 full texts were screened and 16 RCTs met the inclusion criteria. Most interventions combined psychosocial and pharmacological components; motivational interviewing was the most common. Of 39 distinct BCTs identified, 26 were ‘promising’. Frequent BCTs included goal setting (1.1), problem solving (1.2), action planning (1.4), social support (unspecified) (3.1), instruction on how to perform the behaviour (4.1) and pharmacological support (11.1). High overlap exists; most promising BCTs for mental health populations are already embedded within the standard UK pregnancy care pathway. This study shows that behavioural components of effective smoking cessation interventions for people experiencing mental illness align with what is available women accessing NHS smoking in pregnancy cessation services. However, persistently high smoking rates in pregnant women with mental illness suggest that the presence of these techniques alone is insufficient. These findings imply that service improvements should prioritise adapting the delivery of existing BCTs, such as goal setting and problem-solving, to address specific psychological barriers and social contexts of this group to improve engagement and clinical outcomes.

INTRODUCTION:Childbirth-related perineal trauma (CRPT) is the most common complication of vaginal birth, yet its associations with mental health and other health outcomes remain poorly described. This study examined the annual incidence of recorded CRPT by tear degree and investigated its association with mental health and other health outcomes. MATERIAL AND METHODS:We conducted a retrospective cohort study using Clinical Practice Research Datalink Aurum primary care data linked with Hospital Episode Statistics, including women aged ≥16 years who had given birth vaginally between 1st January 2005 and 31st December 2019. Exposure was defined as recorded CRPT of any degree including episiotomy. Annual incidence of CRPT was calculated as a percentage of all births. Cox proportional hazards regression models compared short-, medium-, and long-term (<1 year, 1-5 years, and >5 years post-childbirth) outcomes between women with and without CRPT. We conducted subgroup analyses by degree of tear and in women with spontaneous vertex births, and a sensitivity analysis restricted to first birth. RESULTS:Incidence of recorded CRPT increased from 43.4% to 48.8% between 2005 and 2019. Compared to women without CRPT, those with CRPT had a higher risk of anxiety (aHR 1.19, 95%CI 1.17, 1.22) or depression (aHR 1.23, 95%CI 1.21, 1.25) within 1 year postpartum, with elevated risks persisting beyond 5 years and across all degrees of tear. Women with 1st/2nd degree tears or episiotomy had a higher hazard of post-traumatic stress disorder 1-5 years postpartum. CRPT was associated with increased hazard of urinary incontinence, dyspareunia, reduced libido, vaginal discharge, general and perineal pain, and prolapse in all follow-up periods. Fecal incontinence was increased in women with episiotomy or 3rd/4th degree tears, persisting long-term for severe tears. CRPT was associated with 32% higher risk of antibiotic prescription compared to no CRPT (OR 1.32, 95%CI 1.30, 1.33) within 6 weeks postpartum. CONCLUSIONS:Recorded CRPT was associated with increased risks of diagnosed anxiety and depression in short-, medium- and long-term post-childbirth, irrespective of tear severity, as well as higher risks of other adverse outcomes, including urinary incontinence, pain, and sexual dysfunction. Addressing CRPT should be prioritized to improve women's health and well-being.

OBJECTIVE:To determine the prevalence of perineal wound infection after childbirth-related perineal trauma up to 6 weeks postpartum. DESIGN:Prospective, multi-centre cohort study. SETTING:Fifty-one UK NHS maternity services. POPULATION:There were 2021 women who consented to take part and 1213 women who completed their 6-week questionnaire. METHODS:All women aged 16 or over who sustained childbirth-related perineal trauma of any type after spontaneous or assisted vaginal birth were eligible. Medical record review and distribution of questionnaires took place at 6 weeks postpartum. MAIN OUTCOME MEASURES:The primary outcome was perineal wound infection within 6 weeks postpartum, determined using medical record data and questionnaire response. RESULTS:Six-week medical record check data was available for 1998 women (99%). 1213 (60%) of women completed their 6-week questionnaire. 70.6% of consented women experienced a spontaneous vaginal birth and 29.4% of women an assisted vaginal birth. Across all types of perineal trauma and all modes of birth, the overall rate of perineal wound infection was 5.5% (95% CI 4.6%-6.6%). When considering the rate of wound infection by type of tear, women with episiotomy had the highest rate of wound infection at 9.5% (95% CI 7.5%-11.9%). CONCLUSION:We provide the best estimate to date of perineal wound infection after childbirth-related perineal trauma. Improvements to care to reduce perineal wound infection rates are urgently needed, particularly for groups where currently there are no targeted interventions postnatally, such as women who undergo episiotomy after spontaneous vaginal birth.

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: A mixed- methods study was undertaken with 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: In total, 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 were a parent. Many GPs (n = 326/670, 49%) needed more time than they were allocated for the consultation (n = 524/670 [78%] allocated <= 15 minutes; n = 351/670 [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.

The assets-based feeding help before and after birth (ABA-feed) intervention aims to improve breastfeeding rates by offering proactive peer support to first-time mothers, regardless of feeding intention. Based on behaviour change theory and an assets-based approach, the intervention involved training existing peer supporters to become infant feeding helpers (IFHs). A train-the-trainer model was used, with coordinators delivering four 2-h training sessions to IFHs. Training covered a study overview, IFH role, role-play scenarios and signposting to local assets. Due to COVID-19, training was delivered online. Post-training questionnaires were completed by 22/30 (73.3%) coordinators and 119/193 (61.7%) IFHs, and qualitative interviews were conducted with 24 coordinators and 72 IFHs. Researchers observed training at five sites, assessing fidelity, engagement and delivery quality. Questionnaire data were analysed descriptively, and qualitative data were analysed using framework analysis. Findings indicated that coordinators valued the train-the-trainer model, particularly information on formula feeding and antenatal discussions. IFHs found training engaging and felt prepared, though some were apprehensive about formula feeding support. While online training was convenient, challenges included monitoring discussions and role-play in breakout rooms. Most participants favoured a hybrid approach, with in-person sessions for interactive activities. Observations showed high training fidelity, participant engagement and confidence in delivering intervention components. The ABA-feed training was acceptable to coordinators and IFHs and was delivered with fidelity. Future training should adopt a hybrid approach, incorporating diverse resources and prioritising in-person interactive components such as role-play. Trial Registration: ISRCTN17395671.

BACKGROUND:Since 2020, GP maternal postnatal consultations 6-8 weeks after birth have been mandatory under England's General Medical Services contract. Previously, provision and quality of these consultations was inconsistent, often inadequate. The impact of the mandate is unknown. AIM:To develop an understanding of facilitators and barriers to GPs providing high quality 6-8-week maternal postnatal checks through exploration of views and experiences of women and GPs. METHOD:Mixed methods study focus groups of GPs and women, and an online survey of GPs in England. Qualitative data collection was via focus groups exploring GPs' and women's experiences of postnatal consultations, and an online survey of GPs. Thematic framework analysis was used, with the Capability, Opportunity, Motivation - Behaviour (COM-B) model as an overarching thematic structure. Inductively developed subthemes were mapped to relevant constructs of the COM-B model. RESULTS:Focus groups included 18 women and 14 GPs, the GP survey received 671 responses. Twelve subthemes mapped to six domains of the COM-B model, comprising influences that could be facilitators or barriers to good care. Some influences related to both GPs and women. Some were specific to GPs, such as 'GPs' knowledge', or to women, such as 'Women's social context'. GPs' lived experience impacted their knowledge and motivation. CONCLUSION:GPs and women experienced barriers to good postnatal consultations. Organisational interventions could address; for example, adequate appointment duration, and improved information transfer. Application of the Behaviour Change Wheel to prioritise and develop interventions based on findings could improve women's experience and outcomes.

Background:Perinatal mental illness affects around 20% of women in pregnancy and the first postpartum year with little evidence regarding persistence and incidence in the second year. This study aimed to describe prevalence and incidence of moderate and severe mental illness in the second postpartum year to estimate the proportion of women who could benefit from extension of England's specialist perinatal mental health services to two years. Methods:A retrospective cohort study using United Kingdom primary care Clinical Practice Research Datalink GOLD. All women registered with a General Practitioner with third trimester, delivery code or postpartum medical record 1995-2020 were included. Secondary objectives were to investigate mental illness type and associated factors. Findings:2,132,754 pregnancies from 1,361,497 women were included. Prevalence of mental illness likely to need specialist PMH services in second postpartum year increased significantly from 3.1% (n = 2643/85,756) in 1995 to 7.4% (n = 2473/34,098) in 2018. Incident cases increased from 1.9% (n = 1630/85,756) in 1995 to 3.8% (n = 1285/34,098) in 2018 representing 56.6% (n = 69,926/123,510) of all cases in the second year. Adjusted analysis showed odds of mental illness in second year were higher: for women in most ages vs 30-34 yrs; for each additional pregnancy (OR: 1.16, 95% CI: 1.13, 1.19 two vs one); for preterm births (OR: 1.21, 95% CI: 1.15, 1.27), near term (OR: 1.21, 95% CI: 1.17, 1.25) or post-term (OR: 1.07, 95% CI: 1.04, 1.09) vs term; with history of mental illness (OR: 2.46, 95% CI: 2.41, 2.52), smoking (OR: 1.37, 95% CI: 1.35, 1.39), substance use disorder (OR: 1.54, 95% CI: 1.48, 1.60), and for each year vs 1995. Separate analysis using a subset of data showed odds of mental illness were higher for women in all quintiles vs least deprived and for women of white ethnicity vs all other ethnicities. Although severity could not be accurately measured, most recorded illnesses would require specialist perinatal mental health input. Interpretation:Extension of specialist perinatal mental health services to two years postpartum is justified. Funding:National Institute for Health and Care Research Applied Research Collaboration West Midlands (NIHR200165).

Traditionally, postnatal depression (PND) has been considered as depression in the first year after giving birth, although it has been argued that the 12-month cut-off may be somewhat arbitrary. Specialist perinatal mental health services in England have recently been extended to include women in their second year postpartum; however, there is no good estimate for the prevalence of PND beyond the first year. This review aimed to obtain the best estimate of the prevalence of PND in the second postpartum year. Eligible studies were those that assessed PND and provided a point prevalence using a validated screening tool or clinical diagnosis at least once beyond the first 12 months in women over the age of 18 years in any country. Studies were excluded if they only included women who were already depressed or had elevated depression scores at baseline. PubMed, Embase, Web of Science, CINAHL and PsychINFO were searched in January 2021 (and updated in February 2024) for studies that included the prevalence of PND beyond the first 12 postnatal months. Study quality was assessed using Cochrane's ROBINS-I and Risk of Bias 2 tools. Prevalence data were combined in meta-analysis using prediction intervals (PIs). A total of 6340 papers were found, and of these, 32 studies including 57210 participants across 18 countries met the inclusion criteria and were meta-analysed. The prevalence of PND in the second year (13-24 months) was 15% (95% confidence interval [CI] 12%, 17%; 95% PI 4%, 30%) and similar to that in the first year, 16% (95% CI 14%, 19%; 95% PI 6%, 31%). Despite considerable heterogeneity, common in meta-analysis of prevalence studies, findings show that a similar proportion of women experience PND in the second year after birth.

UK breastfeeding rates are low, with health inequalities in initiation and continuation. Breastfeeding peer support interventions are recommended in UK and global policy. The Assets-based feeding help Before and After birth (ABA-feed) trial tested the effectiveness of proactive, woman-centred support for infant feeding delivered by trained peer supporters (infant feeding helpers; IFHs) in addition to usual care at 17 UK sites. Using data from an embedded process evaluation, this paper reports the views and experiences of women receiving, and the IFHs and coordinators delivering, ABA-feed. Women (n = 2475) were recruited to the trial antenatally; 1458 were allocated to the intervention. Thirty women from five study sites took part in qualitative interviews between 9 and 23 weeks postnatal. IFHs (n = 72) and coordinators (n = 25) from across all sites participated in individual or group interviews towards the end of the intervention period. Interview transcripts were analysed alongside 1147 free-text responses from an 8-week postnatal follow-up survey using Framework Analysis. The ABA-feed intervention was highly acceptable to women, including younger women, those with less education, from diverse ethnic groups, single mothers, and those who intended to formula feed, as well as to IFHs and coordinators. Both remote and in-person support was acceptable. While women valued proactive daily contact during the first 14 days postpartum, some IFHs found this challenging, and some struggled with supporting women who chose formula feeding or were less engaged. This study highlights the value of flexible, proactive, woman-centred infant feeding support. TRIAL REGISTRATION: ISRCTN17395671.

ObjectiveTo investigate pelvic floor dysfunction (PFD; urinary incontinence (UI), faecal incontinence (FI) and prolapse) >= 20 years after childbirth and their association with delivery mode history and demographic characteristics.DesignCohort study with long-term follow-up.SettingMaternity units in Aberdeen and Birmingham (UK) and Dunedin (NZ).PopulationWomen giving birth in 1993/1994.MethodsPostal questionnaires at 20 (New Zealand) or 26 (United Kingdom) years after index birth (n = 6195). Regression analyses investigated associations between risk factors and UI, FI and prolapse symptoms.Main Outcome MeasuresPrevalence of self-reported UI, FI, 'something coming down' from or in the vagina (SCD), and the Pelvic Organ Prolapse-Symptom Score, and relationships with delivery method.ResultsThirty-seven per cent (n = 2270) responded at 20/26 years, of whom 61% reported UI (59% of whom reported more severe UI), 22% FI and 17% prolapse symptoms. Having only caesarean section (CS) was associated with a significantly lower risk of UI (OR 0.63, 95% CI 0.46-0.85), FI (OR 0.63, 95% CI 0.42-0.96) and SCD (OR 0.44, 95% CI 0.27-0.74) compared to only spontaneous vaginal deliveries (SVDs). Having any forceps delivery was associated with reporting FI compared to only SVDs (OR 1.29, 95% CI 1.00-1.66), but there was no association for UI (OR 0.95, 95% CI 0.76-1.19) or SCD (OR 1.05, 95% CI 0.80-1.38). Higher current BMI was associated with all PFD outcomes.ConclusionsPrevalence of PFD continues to increase up to 26 years following index birth, and differences were observed according to delivery mode history. Exclusive CS was associated with less risk of UI, FI and any prolapse symptoms.

Introduction Childbirth-related perineal trauma (CRPT) is the most common complication of childbirth affecting 80% of women overall after vaginal birth. There remains a lack of comprehensive evidence relating to the prevalence of subsequent health problems. Current evidence is related to short-term outcomes, for example, pain, but there is less known about longer-term outcomes such as infection, wound dehiscence, pelvic floor function and psychological outcomes. This is a protocol for a cohort study assessing outcomes of women after CRPT.Methods and analysis A multicentre, prospective UK cohort study aiming to include 1000 women. All women who have sustained CRPT will be eligible for inclusion and will be followed-up for 12 months after childbirth. The primary outcome will be perineal infection at 6 weeks post-birth. Secondary outcomes will include antibiotic use for perineal infection, wound breakdown, use of analgesia, the requirement for admission or surgical intervention, urinary and faecal incontinence, anxiety and depressive symptoms, sexual function and impact on daily activities. Outcomes will be measured at 6 weeks, 6 months and 12 months post partum, with some outcomes being measured at all time points and others at selected most appropriate time points only. Outcome data will be obtained from a review of clinical notes and from patient questionnaires. Simple descriptive statistics will be used to summarise characteristics and outcomes, with categorical variables expressed as percentages and continuous variables as mean averages, alongside the corresponding standard deviatons.Ethics and dissemination Ethical approval has been granted by the Research Ethics Council with reference 23/WA/0169. Data collected from the Childbirth Acquired Perineal Trauma (CHAPTER) cohort study will highlight the prevalence and type of complications after CRPT and which women are more at risk. After the conclusion of this study, findings will be used to work with governmental organisations and Royal Colleges to target resources and ultimately improve care.

Background Antenatal pelvic floor muscle exercises are effective in reducing postnatal urinary incontinence. Midwives, however, lack training and confidence to promote these exercises and often do not provide information or support to women to do the exercises. Objectives Objectives were to: (1) investigate current antenatal care in relation to pelvic floor muscle exercise support from midwives for women; (2) develop an intervention to increase the likelihood of midwives supporting women to do pelvic floor muscle exercises during pregnancy; and (3) test the intervention in a feasibility and pilot cluster randomised controlled trial with numerous trial and process evaluation outcomes. Design Study designs included critical interpretive synthesis, ethnography and other methods (interviews, focus groups, behaviour change theory mapping, stakeholder and patient/public involvement activities) and piloting questionnaires to develop an intervention to test in a feasibility and pilot cluster randomised controlled trial. Clusters were community midwife teams. Setting Main setting: two National Health Service hospital trusts providing maternity care in Birmingham. Participants Participants included pregnant women and midwives. Pilot trial participants included women who gave birth during a prespecified month in study maternity units. Midwives participated in trial process evaluation. Interventions Midwives in teams randomised to the intervention were trained how to teach pelvic floor muscle exercises to women and support them in undertaking these exercises throughout pregnancy. Midwife teams allocated to control provided standard antenatal care. Main outcome measures Early-phase outcomes were whether current antenatal midwife care supported women to undertake pelvic floor muscle exercises, and a midwife pelvic floor muscle exercise training intervention. Main feasibility and pilot trial outcomes included return rates and associated intraclass correlation coefficient; whether midwives provided pelvic floor muscle exercise support to women during antenatal care; women’s adherence to undertaking pelvic floor muscle exercises antenatally; and prevalence estimates of urinary incontinence at 10–12 weeks post partum. Other process outcomes included intervention midwives’ confidence in pelvic floor muscle exercise knowledge and views on intervention delivery; women’s views on pelvic floor muscle exercise support received; and control midwives’ views on pelvic floor muscle exercises in standard care. Results The critical interpretive literature synthesis showed that current antenatal pelvic floor muscle support was constrained by numerous factors including women’s and healthcare professionals’ capacity to implement pelvic floor muscle exercises. Reform of healthcare policy and service delivery was recommended to provide opportunity to genuinely support women and healthcare professionals. Main findings of early-phase qualitative research showed that women and midwives ‘know’ that pelvic floor muscle exercises are important, but that midwives infrequently communicate to women the large ‘gains’ available from undertaking these exercises. There was lack of confidence among women and midwives on when and how to initiate discussion on pelvic floor muscle exercises and urinary incontinence. A systematic review of diagnostic tests for midwives to use to support women’s practice of pelvic floor muscle exercises identified no available studies. Qualitative research with women and midwives, mapping to behaviour change theory, and stakeholder and patient/public involvement activities followed by a practice training event showed that the intervention should consist of five steps: raising the topic of incontinence and pelvic floor muscle exercises; screening for symptoms; teaching the exercises; reminding and supporting women to do the exercises; and knowing when and how to refer. Midwife training evaluation findings showed median positive change following training of 1 point (0–5 scale) for each of eight questions related to confidence about pelvic floor muscle exercise knowledge and teaching the exercises. In the cluster trial, 17 clusters were randomised and 95 midwives in intervention clusters were trained. Of 998 women included in the trial, 175 returned a questionnaire: 15.8% in intervention and 16.4% in control clusters. Based on women’s responses to the post-partum postal questionnaire, 65% of those in intervention clusters said their midwife explained how to do pelvic floor muscle exercises compared to 38% of those in control clusters. Among women in intervention clusters, 50% undertook the exercises in a manner likely to improve symptoms compared to 38% of women in control clusters, and 44% of women in intervention clusters reported urinary incontinence compared to 54% in control clusters. Interviews with midwives and women generally supported trial findings and emphasised the importance of service change for ensuring time to implement the Antenatal Preventative Pelvic floor Exercises And Localisation intervention into antenatal appointments. Limitations There was a low questionnaire return rate. A definitive trial, which would have provided evidence of effectiveness not possible from a pilot trial, could not be undertaken because of changes to standard midwife antenatal care due to National Health Service England’s new perinatal pelvic health service. Conclusions Training midwives to appropriately support women to undertake pelvic floor muscle exercises in pregnancy is feasible, acceptable and could improve exercise adherence and reduce post-partum urinary incontinence. Future work Implementation work with National Health Service England has begun. Study registration This study is registered as ISRCTN10833250. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0514-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 9. See the NIHR Funding and Awards website for further award information. Plain language summary After having a baby, it is very common to leak urine. We know that pelvic floor muscle exercises, when done correctly during pregnancy, can help. The problem is that midwives lack confidence to teach, or do not always explain how to do pelvic floor muscle exercises very well. Even when they do, women may not do them as it is unclear why they should. By talking to many women, midwives and researchers, we developed a way of training midwives to teach and support women during pregnancy to do these exercises. After their training, we found that midwives knew more about pelvic floor muscle exercises and were more confident to teach and support women. To test how well the training worked, we did a pilot trial where midwife teams were randomly selected to be given this training or continue with usual antenatal care. We sent a questionnaire to women when their baby was 3 months old. This asked what advice and support their midwife had given them about pelvic floor muscle exercises during pregnancy, whether they did the exercises, and whether they leaked urine over the last 4 weeks. We found that more women who had antenatal care from a midwife who had been trained were told why and how to do pelvic floor muscle exercises, more of these women did these exercises, and not as many leaked urine. These consistent outcomes are promising, but it was only a pilot trial and not many women returned their questionnaire, so we cannot be certain of these results. We interviewed some women: most were pleased about getting help with pelvic floor muscle exercises and all wanted this help. We interviewed some of the trained midwives. They were keen to help women but said lack of time meant it could be difficult to fit teaching these exercises into antenatal appointments. We could not progress to doing a definitive trial because a new National Health Service perinatal pelvic health service is being set up. However, we have provided the training developed in this programme to many of the lead staff who are setting up the new services. Scientific summary Background A Cochrane Review published when planning this programme showed that antenatal pelvic floor muscle exercises (PFME) in women without urinary incontinence (UI) were effective in reducing postnatal UI. Most interventions in the trials were undertaken by specialist healthcare professionals (HCPs), specifically physiotherapists. It is important to consider whether midwives who provide antenatal care for women could incorporate a suitable PFME intervention into their routine antenatal care since in the UK all women are seen throughout pregnancy by a midwife. Work by the team prior to starting the programme showed that many midwives do not advise women on how to undertake PFME, often due to lack of confidence in how to support women to perform PFME. We also found that women often do not do these exercises in a manner likely to improve their UI symptoms. Objectives To improve the implementation of antenatal PFME and thus reduce the likelihood of UI following childbirth. This was addressed by the following research questions and work packages (WPs): WP1 Particular context awareness: identifying barriers and enablers Why, in the context of organisational practices and cultural norms, do HCPs and women behave the way they do in relation to PFME? WP2 Performance measurement: determining relevant and acceptable measures What is the most accurate and acceptable objective test for pelvic floor muscle (PFM) localisation in pregnancy, and the most appropriate way to capture health economic impact of an intervention? WP3 Plans for change: developing constituents and means of delivery of the intervention What are the suitable means for delivering PFME training to midwives so they can teach and support women during routine antenatal contacts to undertake PFME? What are the most appropriate constituents of a training intervention to enhance PFME implementation, and how should training delivery be optimised? WP4 Piloting the intervention What is the return rate for women’s questionnaires and what is the intraclass correlation coefficient (ICC)? Is it feasible to undertake a full cluster randomised controlled trial (RCT) to assess antenatal midwife PFME implementation, women’s PFME adherence and prevalence of postnatal UI? What do process outcomes show us about intervention implementation and effects? Methods Design WP1.1 Systematic review using critical interpretive synthesis of individual, professional and organisational issues that enable or hinder implementation of PFME training during childbearing years. WP1.2 Qualitative research using ethnographic methods including interviews with pregnant women, some followed postnatally; interviews with midwives and other HCPs and observations of midwives and HCPs in antenatal care. WP2.1 Systematic review of diagnostic accuracy tests to assess PFM localisation. WP2.2 Preliminary decision-analytic model to compare alternative diagnostic and treatment pathways for antenatal prevention of UI. WP3 Intervention development using a range of qualitative methods including focus groups, mapping data to behaviour change theory, and stakeholder and patient and public involvement and engagement (PPIE) activities. WP4.1 Pilot study to test women’s post-partum questionnaires, including individual RCT of long versus short questionnaire. WP4.2 Feasibility and pilot cluster RCT to test the intervention on midwives’ and women’s behaviour in relation to PFME. WP4.3 Process evaluation of RCT using qualitative and quantitative methods. Data sources, study selection, data extraction and data synthesis WP1.1 Sources for review inclusion were identified through databases and purposive searches. Titles and abstracts were screened and appraised using a mixed-methods appraisal tool by two independent reviewers. Findings of included studies were coded using a framework based on initial research questions; patterns and themes were identified; and new constructs were linked to theory developed to explain overall findings. WP1.2 Interview data from pregnant and post-partum women, midwives and HCPs and antenatal care observations were obtained. Analysis included reflexivity, with initial coding to develop a coding framework and to identify emerging themes to guide theme development. The analysis was inductive and deductive in addressing the Antenatal Preventative Pelvic floor Exercises and Localisation (APPEAL) programme objectives. WP2.1 A search strategy was developed in consultation with an international PFME expert and databases, ongoing trials registers and abstracts/conference proceedings were searched from inception to October 2016. All study designs were considered for inclusion except diagnostic case–control studies which are known to overestimate test accuracy. Titles, abstracts and full articles were screened by two independent reviewers, with disagreements resolved by a third. A data extraction proforma and quality assessment tool, based on the QUAlity of Diagnostic Accuracy Studies tool, were prepared. WP2.2 To identify model parameters, a search strategy was developed. Databases were searched to identify formal economic evaluation and cost analysis studies which were screened for inclusion using a two-stage categorisation process. Data on resource use and costs were extracted from included studies. To identify effectiveness and health-related quality-of-life data, targeted literature searches were conducted. Collated evidence informed the preliminary decision-analytic model used. WP3 This comprised four iterative phases: Phase 1 Separate focus groups with pregnant/postnatal women and midwives were conducted in various sites. Data were analysed using thematic analysis. Phase 2 Intervention development used data from WP1 and WP3 phase 1. Comprehensive mapping used the behaviour change wheel (BCW), the theoretical domains framework and the behaviour change technique (BCT) taxonomy. PPIE activity included advisory group meetings and ‘citizens’ jury’ assessment of relevant mobile phone apps; and a national stakeholder event was held which considered midwifery training needs and antenatal service provision. Phase 3 A practice training event was held with midwives in a different region to the future trial. A questionnaire designed to assess midwives’ confidence was completed before and after training. Focus groups after training obtained feedback on intervention format, content, and delivery methods. Researchers facilitated these and recorded discussions and recommendations. Phase 4 Intervention refinement used phase 3 findings and PPIE events to refine the format and content of the package. Additional refinements were subsequently made in response to COVID-19. WP4.1 Piloting of the data collection postal questionnaire was completed by women at 10–12 weeks post partum, comparing return rates from long versus short questionnaires. WP4.2. A feasibility and pilot cluster RCT randomised community midwife teams to intervention and control; intervention teams received PFME training, which was evaluated, and then gave advice and support to all women in their care. Women who gave birth during a predefined 1-month period, chosen so that all their antenatal care occurred during the trial, were sent postal questionnaires (refined from WP4.1) at 10–12 weeks post partum. These were linked to baseline data obtained (with consent) from their hospital records. WP4.3 Process measures included questionnaires (Likert scale response options and free-text space) and audio-recorded interviews with midwives and women, observations of training (using checklists) and meeting notes. Some process outcomes were collected in the 10–12-week women’s questionnaires. Quantitative data were summarised, and qualitative data were analysed with content analysis (free-text data) or thematic analysis (transcribed interview data). Results WP1.1 Fifty quantitative and qualitative sources were found. The concept of agency (ability to effect change through interaction with other people, processes, and systems) provided an overarching explanation of how PFME can be implemented during childbearing years. Women and HCPs, maternity services, and policy-makers all have agency, although their capacity to implement PFME is enhanced or diminished by the professional, organisational, and policy environment. Numerous factors constrained women’s and HCPs’ capacity to implement PFME. The implementation of evidence-based PFME requires policy-makers, organisations, HCPs, and women to value prevention of UI by using low-risk, low-cost and proven strategies. WP1.2 From three maternity units in different parts of England, 23 midwives and 15 pregnant women were interviewed; 12 of the women were followed up postnatally. Interviews were carried out with physiotherapists (n = 4), a link worker/translator (n = 1) and obstetricians (n = 2). Seventeen antenatal clinic observations took place. Key findings were that women and midwives knew that PFME training is important, but often midwives did not communicate to women the gains available from PFME. There was a widespread lack of confidence among women and midwives to initiate conversation about PFME and UI, exacerbated by misunderstandings and assumptions and lack of clear guidelines and policy. WP2.1 A total of 9678 unique titles and abstracts were screened, and 1429 full-text articles were retrieved. No studies met the review inclusion criteria due to an absence of an index test in parallel with the reference standard of digital vaginal palpation. In studies where an index test was conducted in parallel with the reference test, the paper did not provide information from which to derive an estimate of accuracy. WP2.2 Initial results from pre-trial economic analysis suggested some potentially helpful information for trial design and proposed data collection. An example was that the time spent by midwives providing the intervention was not likely to be a key driver in the results and allowed the trial team to be non-prescriptive about midwives recording the time spent with women, an initial concern. The planned health economic analysis was discontinued when the decision was made to change from full to feasibility and pilot cluster trial. WP3 In phase 1, four themes emerged from six focus groups (12 women, 14 midwives) regarding designing the intervention: ‘knowing’, ‘doing’, ‘remembering’ and ‘supporting’ antenatal PFME. Suggestions for maximising implementation included: ‘train the trainer’ model; having a midwife PFME champion within each team; and including knowledge about local referral pathways. Phase 2 mapped findings onto the BCW; elements were coded using the BCT taxonomy. Mapping incorporated comments from PPIE advisers (nine meetings with six mothers) and national stakeholders (20 delegates from 18 relevant maternity service organisations). This resulted in the first iteration of the intervention materials: a five-step midwife training programme and resources for midwives to support PFME implementation, and a resource package for women given by midwives during the antenatal booking appointment. The five steps were: (1) raise the topic of PFME; (2) screen for UI; (3) teach PFME; (4) remind women about how to perform PFME and (5) refresh women’s understanding about PFME and refer to specialist services if required. PPIE advisers helped co-develop resources for women. The phase 3 practice training event showed positive evaluation for content and delivery which participating midwives (n = 18) had found useful. Free-text responses acknowledged the importance of midwives leading regarding PFME, but lack of time, confidence, and skills to raise the issue presented challenges for PFME implementation. Midwives showed increased total PFME confidence from 2.70 (range 1.18–3.50 on a 0–4 scale) before training to 3.68 (range 3.37–4.00) after training. Phase 4 resulted in final modifications to the intervention materials, for example: refresher on muscle exercise physiology training principles; resources for women in a cloth bag the size of a clean nappy. Extensive speaker notes were included to facilitate ‘train the trainer’ plans for future implementation, the training session was shortened from a half-day to 2 hours, and extra resources were developed to support PFME champions. Further modifications, due to COVID-19, enabled remote training delivery by trial staff and enabled midwives to deliver intervention elements to women via telephone appointments. The final WP output was the logic model for the feasibility and pilot trial. WP4.1 In piloting the data collection instruments, 777 women were randomised to being sent a long or short questionnaire. Overall response rate was 31.3% (243/777), with 30.8% (119/387) and 31.8% (124/390) responding in the long and short questionnaire arms, respectively [absolute difference in return rate −1.05%, 95% confidence interval (CI) −7.6% to 5.5%]. While not statistically significant, these results rule out any large differences according to questionnaire length. The ICC of response rate was 0.007 (95% CI 0.0005 to 0.094). Of the total responders, 49% (119/243) reported UI and 64.2% (156/243) reported receiving some advice to perform PFME in pregnancy from their midwife. There were 42.4% (103/243) of women who reported doing PFME often enough (a few times a week or more) to possibly reduce post-partum UI. All responses were similar between the long and short questionnaire trial arms. It was realised that a question about explanation of how to do PFME was important for inclusion in the WP4.2 questionnaire. WP4.2 There were 17 midwifery team clusters randomised, comprising 186 midwives and 1304 women. After exclusions, 998 women were sent a post-partum postal questionnaire and 175 (17.5%) were returned from 88/531 (16.6%) women in intervention clusters and 87/467 (18.6%) in control clusters. Baseline characteristics of the women, including maternal, obstetric and infant characteristics, were similar across trial arms. There was some suggestion of differences between those who did and did not return questionnaires in the proportions of women from ethnic minority groups and having second or subsequent babies, but other baseline characteristics were similar. Based on women’s responses to the questionnaire, 65% (95% CI 56.9% to 72.4%) of those in intervention clusters said their midwife explained how to do PFME, compared to 38% (95% CI 24.6% to 51.2%) in control clusters; 50% (95% CI 24.1% to 77.1%) of women in intervention clusters compared to 38% (95% CI 12.4% to 67.1%) in control clusters undertook PFME in a manner likely to reduce symptoms; 44% (95% CI 32.0% to 56.1%) of women in intervention clusters reported UI compared to 54% (95% CI 42.2% to 65.8%) in control clusters; and 18% (95% CI 6.6% to 28.9%) of women reported faecal incontinence in the intervention clusters compared to 13% (95% CI 4.8% to 21.2%) in control clusters. WP4.3 Training was delivered as intended with acceptable fidelity compared to the training protocol checklist (mean score 86.4%, standard deviation 9.2%), with successful training uptake: all 95 intervention cluster midwives received training. Each team appointed a midwife champion. Most midwives reported acceptability for most training aspects although some would have preferred in-person training. Midwives’ confidence about PFME increased following training (median increase at least 1 point on 0–4 scale for each of eight questions). Implementation questionnaire respondents (n = 59) reported raising the topic (89%), giving the resource bag (68%), teaching a PFME contraction (68%), and practising a contraction in antenatal clinic (45%) with most or all of the women. The most frequently reported barriers were lack of time (26%); forgetting (19%); language (17%); other priorities (15%) and not on the maternity records system (12%) to act as prompt. Intervention midwife interviews (n = 13) indicated positive responses (‘I’m enthusiastic about it’), but there was some ambivalence about the burden of implementation mainly due to workload, limited appointment time, remembering everything and opportunity costs (‘so many other priorities’). Minimal evidence of between-group contamination was found in post-trial interviews with midwives (n = 12 control, n = 6 intervention) and women (n = 16 control, n = 13 intervention). Opportunities for improving implementation included: longer appointments; prompts on records; training update; greater women’s resources accessibility (e.g. online leaflets); and more understanding of referral processes and physiotherapy consultations’ content to aid communication. Conclusions This programme has produced consistent data to demonstrate that training and resourcing antenatal care midwives appropriately to teach and support women to undertake PFME in pregnancy is feasible, could improve women’s PFME adherence and might reduce post-partum UI. A definitive trial would have provided best effectiveness evidence, but this was not possible because of changes to standard antenatal midwife care as a result of NHS England’s new perinatal pelvic health service. So, although there were limitations in this programme of research, it probably represents the best available evidence on whether it is feasible to embed a PFME intervention in standard antenatal care in England and how this can be done. Study registration This study is registered as ISRCTN10833250. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0514-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 9. See the NIHR Funding and Awards website for further award information.

Objective: To determine the change in English emergency postnatal maternal readmissions 2007-2017 (pre-COVID-19) and the association with maternal demographics, obstetric risk factors and postnatal length of stay (LOS). Design: National cohort study. Setting: All English National Health Service hospitals. Population: A total of 6 192 140 women who gave birth in English NHS hospitals from April 2007 to March 2017. Methods: Statistical analysis using birth and readmission data from routinely collected National Hospital Episode Statistics (HES) database. Main Outcome Measures: Rate of emergency postnatal maternal hospital readmissions related to pregnancy or giving birth within 42 days postpartum, readmission diagnoses and association with maternal demographic factors, obstetric risk factors and postnatal LOS. Results: A significant increase in the rate of emergency postnatal maternal readmissions from 15 128 (2.5%) in 2008 to 20 734 (3.4%) in 2016 (aOR 1.32, 95% CI 1.28-1.37) was found. Risk factors for readmission included minoritised ethnicity (particularly Black or Black British ethnicity: aOR 1.35, 95% CI 1.31-1.39); age < 20 years (aOR 1.09, 95% CI 1.05-1.12); 40+ years (aOR 1.07, 95% CI 1.03-1.10); primiparity (multiparity: aOR 0.92, 95% CI 0.91-0.93); nonspontaneous vaginal birth modes (emergency caesarean: aOR 1.86, 95% CI 1.82-1.90); longer LOS (4+ vs. 0 days: aOR 1.58, 95% CI 1.53-1.64); and obstetric risk factors including urinary retention (aOR 2.34, 95% CI 2.06-2.53) and postnatal wound breakdown (aOR 2.01, 95% CI 1.83-2.21). Conclusions: The concerning rise in emergency maternal readmissions should be addressed from a health inequalities perspective focusing on women from minoritised ethnic groups; those <20 and >= 40 years old; primiparous women; and those with specified obstetric risk factors.