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.

Quantitative assessment of pregnancy outcome following recurrent miscarriage clinic care: a prospective cohort study.

OBJECTIVES: To measure pregnancy outcome following attendance at a recurrent miscarriage service and identify factors that influence outcome. DESIGN: Prospective, observational electronic cohort study. SETTING: Participants attending a specialist recurrent miscarriage clinic, with a history of two or more pregnancy losses. 857 new patients attended over a 30-month period and were invited to participate. Participant data were recorded on a bespoke study database, 'Tommy's Net'. PARTICIPANTS: 777 women consented to participate (90.7% of new patients). 639 (82%) women continued within the cohort, and 138 were lost to follow-up. Mean age of active participants was 34 years for women and 37 years for partners, with a mean of 3.5 (1-19) previous pregnancy losses. Rates of obesity (maternal: 23.8%, paternal: 22.4%), smoking (maternal:7.4%, paternal: 19.4%) and alcohol consumption (maternal: 50%, paternal: 79.2%) were high and 55% of participants were not taking folic acid. OUTCOME MEASURES: Biannual collection of pregnancy outcomes, either through prompted self-reporting, or existing hospital systems. RESULTS: 639 (82%) women were followed up. 404 (83.4%) reported conception and 106 (16.6%) reported no pregnancy, at least 6 months following registration. Of those that conceived, 72.8% (294/404) had a viable pregnancy. Maternal smoking and body mass index (BMI) over 30 were significantly higher in those who did not conceive (p=0.001) CONCLUSIONS: Tommy's Net provides a secure electronic repository on data for couples with recurrent pregnancy loss and associated outcomes. The study identified that subfertility, as well as repeated miscarriage, maternal BMI and smoking status, contributed to failure to achieve live birth. Study findings may enable comparison of clinic outcomes and inform the development of a personalised holistic care package.

Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.

BACKGROUND: Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB. METHODS AND FINDINGS: We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data. CONCLUSIONS: In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability. TRIAL REGISTRATION: We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.

Maternity service organisational interventions that aim to reduce caesarean section: a systematic review and meta-analyses.

BACKGROUND: Caesarean sections (CSs) are associated with increased maternal and perinatal morbidity, yet rates continue to increase within most countries. Effective interventions are required to reduce the number of non-medically indicated CSs and improve outcomes for women and infants. This paper reports findings of a systematic review of literature related to maternity service organisational interventions that have a primary intention of improving CS rates. METHOD: A three-phase search strategy was implemented to identify studies utilising organisational interventions to improve CS rates in maternity services. The database search (including Cochrane CENTRAL, CINAHL, MEDLINE, Maternity and Infant Care, EMBASE and SCOPUS) was restricted to peer-reviewed journal articles published from 1 January 1980 to 31 December 2017. Reference lists of relevant reviews and included studies were also searched. Primary outcomes were overall, planned, and unplanned CS rates. Secondary outcomes included a suite of birth outcomes. A series of meta-analyses were performed in RevMan, separated by type of organisational intervention and outcome of interest. Summary risk ratios with 95% confidence intervals were presented as the effect measure. Effect sizes were pooled using a random-effects model. RESULTS: Fifteen articles were included in the systematic review, nine of which were included in at least one meta-analysis. Results indicated that, compared with women allocated to usual care, women allocated to midwife-led models of care implemented across pregnancy, labour and birth, and the postnatal period were, on average, less likely to experience CS (overall) (average RR 0.83, 95% CI 0.73 to 0.96), planned CS (average RR 0.75, 95% CI 0.61 to 0.93), and episiotomy (average RR 0.84, 95% CI 0.74 to 0.95). Narratively, audit and feedback, and a hospital policy of mandatory second opinion for CS, were identified as interventions that have potential to reduce CS rates. CONCLUSION: Maternity service leaders should consider the adoption of midwife-led models of care across the maternity episode within their organisations, particularly for women classified as low-risk. Additional studies are required that utilise either audit and feedback, or a hospital policy of mandatory second opinion for CS, to facilitate the quantification of intervention effects within future reviews. PROSPERO REGISTRATION: CRD42016039458 ; prospectively registered.

Effectiveness of Trauma-Focused Psychological Therapies for Treating Post-traumatic Stress Disorder Symptoms in Women Following Childbirth: A Systematic Review and Meta-Analysis.

Background: Approximately 3% of women in community samples develop posttraumatic stress disorder (PTSD) after childbirth. Higher prevalence rates are reported for high risk samples. Postpartum PTSD can adversely affect women's wellbeing, mother-infant relationships and child development. This study aims to examine the effectiveness of trauma-focused psychological interventions (TFPT), for postnatal women. Methods: We conducted a systematic review and meta-analysis including all clinical trials which reported post-traumatic stress symptoms for both the intervention and control groups or at least two time-points, pre- and post-intervention. We searched four databases: CENTRAL, MEDLINE, PsycINFO, and OpenGrey. Screening of search results, data extraction, and risk of bias assessment were undertaken independently by two reviewers. Results: Eleven studies, reported in 12 papers, involving 2,677 postnatal women were included. All were RCTs, bar one case series. Interventions varied in modality, duration and intensity, and included exposure therapy, trauma-focused cognitive behavioral therapy, eye movement desensitization and reprocessing and other psychological approaches. Participants had experienced uncomplicated births, emergency cesarean sections and/or preterm births. Results suggest that TFPT are effective for reducing PTSD symptoms in the short term (up to 3 months postpartum [4 RCTs, n = 301, SMD = -0.50, 95% CI = -0.73 to -0.27]), and medium term (i.e., 3-6 months postpartum [2 RCTs, n = 174, SMD = -1.87, 95% CI = -2.60 to -1.13]). However, there is no robust evidence to suggest whether TFPT can also improve women's recovery from clinically significant PTSD symptoms. Conclusion: Further larger studies, distinguishing between low and high risk groups, and with adequate follow-up, are needed to establish which TFPT are most effective and acceptable for treating postnatal PTSD.

Establishing a Europe-wide foundation for high quality midwifery education: The role of the European Midwives Association (EMA).

A cornerstone of European policy involves freedom of movement of individuals between member countries, which applies equally to those who use and provide maternity care. To promote and support safe, high quality maternity care, minimum standards for midwifery education and practice have been published, including Directives EEC/80/154 and EEC/80/155 which support the recognition of professional qualifications. These Directives established a minimum standard for midwifery education, including the duration and content of theoretical and practical education. Annex V of the Directives established a framework of professional activities to define and guide the scope of midwifery practice in EU member countries. The Directives were updated in 2013, with the European Midwives Association (EMA) an important partner in this process. While the degree of implementation of the Directives at individual country level varies, EMA has an ongoing role in ensuring, promoting and advancing high quality midwifery education and practice throughout the EU.

Barriers to identifying eating disorders in pregnancy and in the postnatal period: a qualitative approach.

BACKGROUND: Eating Disorders (ED) are mental health disorders that typically effect women of childbearing age and are associated with adverse maternal and infant outcomes. UK healthcare guidance recommends routine enquiry for current and past mental illness in antenatal and postnatal care for all women, and that pregnant women with a known ED are offered enhanced monitoring and support. Midwives and health visitors are ideally placed to identify and support women with ED as they are often the primary point of contact during the antenatal and postnatal periods. However, research on the barriers to identifying ED in the perinatal period is limited. This study aimed to understand the barriers to disclosure and identification of ED in pregnancy and postnatally as perceived by women with past or current ED, and midwives and health visitors working in the UK National Health Service. METHODS: Two studies were undertaken: mixed-measures survey of pregnant and postnatal women with current or past ED; focus groups with student and qualified midwives and health visitors. RESULTS: Five themes emerged on the barriers to disclosure in pregnancy as perceived by women: stigma, lack of opportunity, preference for self-management, current ED symptomatology and illness awareness. Four themes were identified on the barriers to identification of ED in pregnancy and in the postnatal period as perceived by health professionals: system constraints, recognition of role, personal attitudes, and stigma and taboo. CONCLUSIONS: Several barriers to the identification of ED during and after pregnancy were described, the main factors were stigma and poor professional training. Perinatal mental health is becoming increasingly prioritised within national policy initiatives; however, ED continue to be neglected and increased awareness is needed. Similarly, clinical guidance aimed at responding to the rising prevalence of obesity focus on changing nutrition but not on assessing for the presence of ED behaviours that might be affecting nutrition. Improving education and training for health professionals may contribute to reducing stigma and increase confidence in identifying ED. The barriers identified in this research need to be addressed if recognition and response to women with ED during the perinatal period is to improve.

A national cross sectional survey of heads of midwifery services of uptake, benefits and barriers to use of obstetric early warning systems (EWS) by midwives.

OBJECTIVE: to identify the extent to which Early Warning Systems (EWS) are used by midwives in the United Kingdom (UK), the maternity settings they are used in, physiological parameters used to 'trigger' referral, training provision, barriers to implementation and role in preventing maternal morbidity. DESIGN: cross-sectional survey of heads of midwifery services. An email questionnaire was sent in September 2012. SETTING: UK NHS secondary care organisations providing maternity care. FINDINGS: heads of midwifery from 107 (68%) of 157 NHS organisations responded, with 108 questionnaires returned as two organisations had recently merged. All organisations, apart from one which only had a free-standing midwifery unit, had introduced EWS. Nearly all respondents (99%) reported EWS were used by midwives antenatally, 76% in labour and 100% on the postnatal ward. All EWS charts included body temperature, heart rate, respiratory rate, systolic blood pressure and oxygen saturation although parameters for escalation varied widely. Barriers to use of EWS by midwives included overlap with the partogram in labour, and staff shortages and delays obtaining clinical review when referral was triggered. Two-thirds considered EWS prevented maternal morbidity although few could provide supporting evidence, for example, audit findings. Training for midwives in use of EWS was available in 83% of organisations. CONCLUSION: most UK midwives are using EWS, with the highest use in obstetric units. The heterogeneity of EWS currently used potentially limits collation of evidence to inform appropriate system level responses. Research is needed to evaluate the role of EWS to prevent maternal morbidity during and after pregnancy in different maternity settings.

Women's perceptions and experiences of severe maternal morbidity--a synthesis of qualitative studies using a meta-ethnographic approach.

BACKGROUND: maternal mortality is a relatively rare event in high-income countries and some middle-income countries. There is however a rising trend in the overall rate of severe maternal morbidity in many of these countries due to the increasingly complex obstetric and medical needs of women who become pregnant. With the aim to identify how women's experiences of health services following severe maternal morbidity could be improved, we explored women's perceptions and experiences of severe maternal morbidity (defined as major obstetric haemorrhage, severe preeclampsia, eclampsia, HELLP syndrome, critical care unit admission) by synthesising evidence from qualitative studies. METHODS: a systematic search of the literature was conducted using multiple databases, including MEDLINE, PsycINFO, EMBASE, CINAHL, British Nursing Index (BNI), Web of Science and Scopus, using predetermined search strategies. Studies were selected based on pre-defined inclusion and exclusion criteria. The methodological quality of selected qualitative studies was assessed using relevant CASP appraisal tools. Evidence synthesis was undertaken using meta-ethnography. The synthesis involved three steps: (1) ascertaining how studies were related or dissimilar through comparison; (2) translating one study's findings into another and (3) synthesis of the translation. FINDINGS: 12 studies met inclusion criteria. Synthesis of these studies showed that women's experiences of severe maternal morbidity can be broadly categorised into three areas: experiencing the event of severe maternal morbidity, the immediate reaction to the event (physical experience, perception/interpretation of their situation, and emotion), and the aftermath (either a negative or positive experience), which are all interconnected. Women's experiences of severe maternal morbidity may be influenced by other factors such as the individuals' personal characteristics, pre-existing health conditions, feeling safe within the care provided, availability and accessibility of high quality health care, and their wider social support networks. Importantly, women's perceptions and experiences of severe maternal morbidity could be compounded by inadequate clinical management and care. CONCLUSIONS: an experience of severe maternal morbidity and its subsequent management are physically and emotionally distressing, conjuring negative feelings and emotions and possibly poor postnatal outcomes. Findings suggest the importance of ensuring that the safety and quality of intrapartum interventions and models of postnatal care are enhanced, to reduce or prevent subsequent implications of an acute medical event on women and their families.