The GP's role in supporting women with anal incontinence after childbirth injury.

BACKGROUND: Obstetric anal sphincter injury is the most common cause of anal incontinence (AI) for women, which often has profound impacts on women's lives. GPs offer a first line of contact for many, but we know that very few women experiencing AI postnatally report discussing it with their GPs. DESIGN AND SETTING: Qualitative study investigating women's experiences with their GP and GPs' perspectives about providing such care. AIM: The study aims to identify key ways GPs can support women with AI due to childbirth injuries. METHOD: This qualitative study combined two phases: firstly, a series of in-depth interviews with women experiencing AI caused by childbirth injuries (n=41); secondly, 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 AI caused by childbirth injuries centred around three key themes: Role of the GP, Access and Pathways, and Communication. CONCLUSION: The findings demonstrate multifactorial challenges in identifying the problem and supporting women experiencing AI after childbirth injury within primary care settings. Many GPs lacked confidence in their role in supporting women and women were often reluctant to seek help. Those who did often experienced frustrations consulting with their GPs. In a context where women are often reluctant to ask for help, concerns are not always taken seriously, and where GPs do not routinely ask about AI, potential AI 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.

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.

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.

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.

Cost-effectiveness of screening tools for identifying depression in early pregnancy: a decision tree model.

BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.

Mode of birth and development of maternal postnatal post-traumatic stress disorder: A mixed-methods systematic review and meta-analysis.

BACKGROUND: Post-traumatic stress disorder (PTSD) affects approximately 3% of women in the postnatal period, but less is known about risk factors for PTSD than other postnatal mental illnesses. This review aimed to analyze the literature on the impact of mode of birth on postnatal PTSD. METHODS: Searches were undertaken of CINAHL, the Cochrane Library, MEDLINE, PsycINFO, and Scopus for studies investigating the link between mode of birth and postnatal PTSD in high-resource countries from January 1990 to February 2021. Quantitative and qualitative data were collected and synthesized. Meta-analysis was performed with four of the studies, and the rest were analyzed narratively. RESULTS: Twelve quantitative studies, presenting data on 5567 women, and two qualitative studies, with 92 women, were included in the review. Most studies found a significant relationship between mode of birth and maternal PTSD symptoms. Meta-analysis found cesarean birth was more closely associated with PTSD than vaginal delivery (VD) (P = 0.005), emergency cesarean birth (EmCB) more than elective cesarean birth (ElCB) (P < 0.001), instrumental vaginal delivery (IVD) more than spontaneous vaginal delivery (SVD) (P < 0.001), and EmCB more than SVD (P < 0.001). Women who developed PTSD after EmCB felt less in control and less supported than those who did not develop it after the same procedure. Request for repeat ElCB appeared more common among women with pre-existing postnatal PTSD, but this may subsequently leave them feeling dissatisfied and their fears of childbirth unresolved. CONCLUSIONS: Modes of birth involving emergency intervention may be risk factors for the development of postnatal PTSD. Ensuring that women feel supported and in control during emergency obstetric interventions may mediate against this risk.

Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study).

INTRODUCTION: One in 10 women have hypertensive disorders in pregnancy (HDP) and are at risk of adverse short- and long-term health outcomes, yet there is limited information on their postnatal health and care needs. This study aimed to look at postnatal physical and psychological morbidity in women with HDP, compared to women without HDP, and the postnatal care received in both groups. METHODS: Within a prospective cohort study, women with and without HDP were identified and recruited on the postnatal ward of 17 maternity units across England and invited to complete a short baseline questionnaire. At 3 months postpartum, women were sent a follow-up questionnaire, with reminders. The principal outcomes were the mean score at 3 months for the Edinburgh Postnatal Depression Scale (EPDS) and the EuroQol Group 5-dimension (EQ-5D) scale. RESULTS: One thousand eight hundred twenty-nine women agreed to participate. Of these, 1757 (96%) completed the baseline questionnaire: 769 (44%) women had HDP and 988 (56%) women did not. Despite a difference in health-related quality of life and symptoms of depression at baseline between the two groups, at 3 months postnatal, within the 653 women who completed their follow-up questionnaire (37.2% of those who completed the baseline questionnaire) there were no significant differences between the groups (median EQ-5D VAS: 85 in women with HDP, 85 in women without HDP, p = 0.99 and mean EPDS score 5.5 in women with HDP, 5.0 in women without HDP, p = 0.80). Overall levels of physical postnatal morbidity were high, with 89% reporting one or more morbidities. Approximately 9% of women were re-admitted within 3 months after birth, higher in the HDP group (13.1%) higher compared to women without HDP (5.5%; RR 2.41; 95% CI 1.44-4.05). CONCLUSION: Overall levels of physical and psychological morbidity were high in this postnatal population. Although there were increased needs of women with HDP in the immediate postnatal period (compared to other women), their health assessments were similar at 3 months. This study highlights the unmet needs of women in the postnatal period, in addition to a missed opportunity to influence future pregnancies and improve the longer-term health of women and their babies.

Understanding maternal postnatal blood pressure changes following hypertensive disorders in pregnancy: protocol for a prospective cohort study.

INTRODUCTION: Hypertensive disorders occur in approximately 10% of women during pregnancy. There is robust population-based data to show that women who have hypertension in pregnancy are much more likely to develop cardiovascular disease (CVD) in the postpartum period. Women with a hypertensive disorder of pregnancy (HDP) are twice more at risk of heart disease and stroke, and four times more likely to develop hypertension after birth. Two out of three women who had HDP will die from CVD. Recent evidence suggests that young women with HDP develop signs of CVD in the immediate postpartum period, rather than several decades later as previously presumed. If confirmed, this concerning finding presents healthcare practitioners with an opportunity to influence women's cardiovascular health by advising on lifestyle choices and considering therapeutic interventions to prevent the development of CVD. METHODS AND ANALYSIS: This prospective cohort study design will ask approximately 300 participants to complete 3 days of home blood pressure monitoring every fortnight for 12 weeks postpartum and will culminate with a 24-hour episode of ambulatory blood pressure monitoring at 12 weeks postpartum. Women and healthcare professionals will complete questionnaires surrounding postpartum care for women who had HDP and knowledge of CVD risk. In addition, the relationship between hypertension and factors likely to influence outcomes such as severity of HDP, maternal age, body mass index and ethnicity will be analysed using logistic regression. Blood pressure and data from questionnaires will be analysed using descriptive statistics, with temporal stratification. ETHICS AND DISSEMINATION: Research ethics approval was obtained from London-West London & GTAC Research Ethics Committee. Research outputs will be published and disseminated through midwifery, obstetric or general practitioner targeted academic journals. The patient and public involvement group will disseminate findings to women who have experienced HDP among their peer groups. TRIAL REGISTRATION NUMBER: NCT05137808.

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance.

BACKGROUND: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. METHODS: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18-45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80-100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. DISCUSSION: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. TRIAL REGISTRATION: ISRCTN47576591 ; February 8, 2022.