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Background Around 1 in 150 babies are stillborn or die in the first month of life in the UK. Most women conceive again, and subsequent pregnancies are often characterised by feelings of stress and anxiety, persisting beyond the birth. Psychological distress increases the risk of poor pregnancy outcomes and longer-term parenting difficulties. Appropriate emotional support in subsequent pregnancies is key to ensure the wellbeing of women and families. Substantial variability in existing care has been reported, including fragmentation and poor communication. A new care package improving midwifery continuity and access to emotional support during subsequent pregnancy could improve outcomes. However, no study has assessed the feasibility of a full-scale trial to test effectiveness in improving outcomes and cost-effectiveness for the National Health Service (NHS). Methods A prospective, mixed-methods pre-and post-cohort study, in two Northwest England Maternity Units. Thirty-eight women, (≤ 20 weeks’ gestation, with a previous stillbirth, or neonatal death) were offered the study intervention (allocation of a named midwife care coordinator and access to group and online support). Sixteen women receiving usual care were recruited in the 6 months preceding implementation of the intervention. Outcome data were collected at 2 antenatal and 1 postnatal visit(s). Qualitative interviews captured experiences of care and research processes with women (n = 20), partners (n = 5), and midwives (n = 8). Results Overall recruitment was 90% of target, and 77% of women completed the study. A diverse sample reflected the local population, but non-English speaking was a barrier to participation. Study processes and data collection methods were acceptable. Those who received increased midwifery continuity valued the relationship with the care coordinator and perceived positive impacts on pregnancy experiences. However, the anticipated increase in antenatal continuity for direct midwife contacts was not observed for the intervention group. Take-up of in-person support groups was also limited. Conclusions Women and partners welcomed the opportunity to participate in research. Continuity of midwifery care was supported as a beneficial strategy to improve care and support in pregnancy after the death of a baby by both parents and professionals. Important barriers to implementation included changes in leadership, service pressures and competing priorities. Trial registration ISRCTN17447733 first registration 13/02/2018.

Background The grief associated with the death of a baby is enduring, however most women embark on another pregnancy, many in less than a year following their loss. Symptoms of anxiety and depression are reported to be increased in pregnancies after perinatal death, although effect on maternal stress is less clear. Variation between individual studies may result from differences in gestation at sampling, the questionnaire used and the type of antecedent perinatal death. We aimed to describe quantitative measures of anxiety, depression, stress and quality of life at different timepoints in pregnancies after perinatal death and in the early postnatal period. Methods Women recruited from three sites in the North-West of England. Women were asked to participate if a previous pregnancy had ended in a perinatal death. Participants completed validated measures of psychological state (Cambridge Worry Score, Edinburgh Postnatal Depression Score (EPDS), Generalized Anxiety Disorder 7-item score) and health status (EQ-5D-5L™ and EQ5D-Visual Analogue Scale) at three time points, approximately 15 weeks’ and 32 weeks’ gestation and 6 weeks postnatally. A sample of hair was taken at approximately 36 weeks’ gestation for measurement of hair cortisol in a subgroup of women. The hair sample was divided into samples from each trimester and cortisol measured by ELISA. Results In total 112 women participated in the study. Measures of anxiety and depressive symptoms decreased from the highest levels at 15 weeks’ gestation to 6-weeks postnatal (for example mean GAD-7: 15 weeks 8.2 ± 5.5, 6 weeks postnatal 4.4 ± 5.0, p Conclusions This study demonstrated heightened anxiety and depressive symptoms and elevated cortisol levels in women in pregnancies after a stillbirth or neonatal death which decrease as pregnancy progresses. Further studies are needed to determine optimal care for women to address these negative psychological consequences.

Background Late stillbirth continues to affect 3–4/1000 pregnancies in high-resource settings, with even higher rates in low-resource settings. Reduced foetal movements are frequently reported by women prior to foetal death, but there remains a poor understanding of the reasons and how to deal with this symptom clinically, particularly during the preterm phase of gestation. We aimed to determine which women are at the greatest odds of stillbirth in relation to the maternal report of foetal movements in late pregnancy (≥ 28 weeks’ gestation). Methods This is an individual participant data meta-analysis of all identified case-control studies of late stillbirth. Studies included in the IPD were two from New Zealand, one from Australia, one from the UK and an internet-based study based out of the USA. There were a total of 851 late stillbirths, and 2257 controls with ongoing pregnancies. Results Increasing strength of foetal movements was the most commonly reported (> 60%) pattern by women in late pregnancy, which were associated with a decreased odds of late stillbirth (adjusted odds ratio (aOR) = 0.20, 95% CI 0.15 to 0.27). Compared to no change in strength or frequency women reporting decreased frequency of movements in the last 2 weeks had increased odds of late stillbirth (aOR = 2.33, 95% CI 1.73 to 3.14). Interaction analysis showed increased strength of movements had a greater protective effect and decreased frequency of movements greater odds of late stillbirth at preterm gestations (28–36 weeks’ gestation). Foetal hiccups (aOR = 0.45, 95% CI 0.36 to 0.58) and regular episodes of vigorous movement (aOR = 0.67, 95% CI 0.52 to 0.87) were associated with decreased odds of late stillbirth. A single episode of unusually vigorous movement was associated with increased odds (aOR = 2.86, 95% CI 2.01 to 4.07), which was higher in women at term. Conclusions Reduced foetal movements are associated with late stillbirth, with the association strongest at preterm gestations. Foetal hiccups and multiple episodes of vigorous movements are reassuring at all gestations after 28 weeks’ gestation, whereas a single episode of vigorous movement is associated with stillbirth at term.

Background Stillbirth remains a major concern across the globe and in some high-resource countries, such as the UK; efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small for gestational age (SGA), and these pregnancies are also at risk of neonatal adverse outcomes and lifelong health problems, especially when delivered preterm. Current UK clinical guidance advocates regular monitoring and early term delivery of the SGA fetus; however, the most appropriate regimen for surveillance of these babies remains unclear and often leads to increased intervention for a large number of these women. This pilot trial will determine the feasibility of a large-scale trial refining the risk of adverse pregnancy outcome in SGA pregnancies using biomarkers of placental function sFlt-1/PlGF, identifying and intervening in only those deemed at highest risk of stillbirth. Methods PLANES is a randomised controlled feasibility study of women with an SGA fetus that will be conducted at two tertiary care hospitals in the UK. Once identified on ultrasound, women will be randomised into two groups in a 3:1 ratio in favour of sFlt-1/PlGF ratio led management vs standard care. Women with an SGA fetus and a normal sFlt-1/PlGF ratio will have a repeat ultrasound and sFlt-1/PlGF ratio every 2 weeks with planned birth delayed until 40 weeks. In those women with an SGA fetus and an abnormal sFlt-1/PlGF ratio, we will offer birth from 37 weeks or sooner if there are other concerning features on ultrasound. Women assigned to standard care will have an sFlt-1/PlGF ratio taken, but the results will be concealed from the clinical team, and the woman’s pregnancy will be managed as per the local NHS hospital policy. This integrated mixed method study will also involve a health economic analysis and a perspective work package exploring trial feasibility through interviews and questionnaires with participants, their partners, and clinicians. Discussion Our aim is to determine feasibility through the assessment of our ability to recruit and retain participants to the study. Results from this pilot study will inform the design of a future large randomised controlled trial that will be adequately powered for adverse pregnancy outcome. Such a study would provide the evidence needed to guide future management of the SGA fetus. Trial registration ISRCTN58254381. Registered on 4 July 2019

Objectives Early-onset severe preeclampsia is associated with significant maternal and perinatal morbidity and mortality especially in low-resource settings, where women have limited access to antenatal care. This dataset was generated from a retrospective cross-sectional study carried out at Mpilo Central Hospital, covering the period February 1, 2016 to July 30, 2018. The aim of the study was to determine the incidence of early-onset severe preeclampsia and eclampsia, and associated risk factors in a low-resource setting. The reason for examining the incidence of preeclampsia specifically in a low-resource setting; was to document it as women in these settings appear to suffer from poor outcomes. Data description The dataset contains data of 238 pregnant women who had a diagnosis of early onset severe preeclampsia/eclampsia. There were 243 babies from singleton and twin gestations. There were five sets of twins. There were 21,505 live births during the study period giving an incidence of 1.1%. The dataset contains data on maternal socio-demographic, signs and symptoms, therapeutic interventions and mode of delivery, adverse outcomes characteristics, and fetal characteristics. This large dataset can be used to calculate the incidence and risk factors for adverse maternal and fetal outcomes or develop predictive models in severe preeclampsia/eclampsia.

Background The Midlands and North of England Stillbirth Study (MiNESS) was a case-control study of women who had a stillbirth or who had an ongoing pregnancy. During the set up phase questions were raised about whether interviewing women within six weeks of a stillbirth and recruiting women who were still pregnant into a “stillbirth” study was acceptable. This led to the research questions “whether it is appropriate to ask women who have recently experienced a stillbirth to participate in research?” and “whether it is appropriate to ask pregnant women to participate in a research project looking at factors associated with stillbirth.” This nested study aimed to describe the opinions of women approached to participate in MiNESS to explore their views and experiences of a research project focussed on stillbirth. Methods Semi- structured interviews were conducted at a single study site involved in MiNESS. Purposive sampling was used to obtain a sample of women who were approached following a stillbirth (case n = 6) and those who were approached during pregnancy who gave birth to a live born baby (control n = 6). These two groups of women were divided equally according to whether they participated in the main MiNESS questionnaire study and those who declined to do so (n = 3 in each group). Interview data were transcribed and analysed using thematic analysis to identify the most important factors in determining whether women participated in MiNESS. Results The following themes emerged from the analysis: participants’ understanding of research; approach by researcher; wanting to help; stillbirth taboo. These themes are explored individually in the manuscript. Participants reported positive views about research and previous participation in research studies. Respondents valued an initial approach from a member of staff already known to them. The taboo around stillbirth was a barrier to participation for some women with ongoing pregnancies. Conclusions Experiences and views regarding research differed between participants and non-participants in the MiNESS study. Participants reported a greater understanding of the importance and implications of clinical research. When designing future studies, the timing of approach, clarity of information and the person approaching potential participants should be considered to optimise recruitment. Trial registration NCT02025530 date registered: 01/01/2014.

Background: Pregnancy after stillbirth or neonatal death is an emotionally challenging life-event for women and adequate emotional support during pregnancy should be considered an essential component of quality maternity care. There is a lack of evidence surrounding the role of UK maternity services in meeting womens' emotional and psychological needs in subsequent pregnancies. This study aimed to gain an overview of current UK practice and womens' experiences of care in pregnancy after the death of a baby. Methods: Online cross-sectional surveys, including open and closed questions, were completed on behalf of 138 United Kingdom (UK) Maternity Units and by 547 women who had experience of UK maternity care in pregnancy after the death of a baby. Quantitative data were analysed descriptively using SPSS software. Open textual responses were managed manually and analysed using the framework method. Results: Variable provision of care and support in subsequent pregnancies was identified from maternity unit responses. A minority had specific written guidance to support care delivery, with a focus on antenatal surveillance and monitoring for complications through increased consultant involvement and technological surveillance (ultrasound/cardiotocography). Availability of specialist services and professionals with specific skills to provide emotional and psychological support was patchy. There was a lack of evaluation/dissemination of developments and innovative practice. Responses across all UK regions demonstrated that women engaged early with maternity care and placed high value on professionals as a source of emotional support. Many women were positive about their care, but a significant minority reported negative experiences. Four common themes summarised womens' perceptions of the most important influences on quality and areas for development: sensitive communication and conduct of staff, appropriate organisation and delivery of services, increased monitoring and surveillance and perception of standard vs. special care. Conclusions: These findings expose likely inequity in provision of care for UK parents in pregnancy after stillbirth or neonatal death. Many parents do not receive adequate emotional and psychological support increasing the risk of poor health outcomes. There is an urgent need to improve the evidence base and develop specific interventions to enhance appropriate and sensitive care pathways for parents.

Background\ud \ud Maternal perception of reduced fetal movements (RFM) is associated with increased risk of fetal growth restriction (FGR) and stillbirth, mediated by placental insufficiency. The maternally expressed imprinted gene PHLDA2 controls fetal growth, placental development and placental lactogen production in a mouse model. A number of studies have also demonstrated abnormally elevated placental PHLDA2 expression in human growth restricted pregnancies. This study examined whether PHLDA2 was aberrantly expressed in placentas of RFM pregnancies resulting in delivery of an FGR infant and explored a possible relationship between PHLDA2 expression and placental lactogen release from the human placenta.\ud Methods\ud \ud Villous trophoblast samples were obtained from a cohort of women reporting RFM (N = 109) and PHLDA2 gene expression analysed. hPL levels were assayed in the maternal serum (N = 74).\ud Results\ud \ud Placental PHLDA2 expression was significantly 2.3 fold higher in RFM pregnancies resulting in delivery of an infant with FGR (p

Background Despite improvements in maternity healthcare services over the last few decades, more than 2.7 million babies worldwide are stillborn each year. The global health agenda is silent about stillbirth, perhaps, in part, because its wider impact has not been systematically analysed or understood before now across the world. Our study aimed to systematically review, evaluate and summarise the current evidence regarding the psychosocial impact of stillbirth to parents and their families, with the aim of improving guidance in bereavement care worldwide. Methods Systematic review and meta-summary (quantitative aggregation of qualitative findings) of quantitative, qualitative, and mixed-methods studies. All languages and countries were included. Results Two thousand, six hundred and nineteen abstracts were identified; 144 studies were included. Frequency effect sizes (FES %) were calculated for each theme, as a measure of their prevalence in the literature. Themes ranged from negative psychological symptoms post bereavement (77 · 1) and in subsequent pregnancies (27 · 1), to disenfranchised grief (31 · 2), and incongruent grief (28 · 5), There was also impact on siblings (23 · 6) and on the wider family (2 · 8). They included mixed-feelings about decisions made when the baby died (12 · 5), avoidance of memories (13 · 2), anxiety over other children (7 · 6), chronic pain and fatigue (6 · 9), and a different approach to the use of healthcare services (6 · 9). Some themes were particularly prominent in studies of fathers; grief suppression (avoidance)(18 · 1), employment difficulties, financial debt (5 · 6), and increased substance use (4 · 2). Others found in studies specific to mothers included altered body image (3 · 5) and impact on quality of life (2 · 1). Counter-intuitively, Some themes had mixed connotations. These included parental pride in the baby (5 · 6), motivation for engagement in healthcare improvement (4 · 2) and changed approaches to life and death, self-esteem, and own identity (25 · 7). In studies from low/middle income countries, stigmatisation (13 · 2) and pressure to prioritise or delay conception (9) were especially prevalent. Conclusion Experiencing the birth of a stillborn child is a life-changing event. The focus of the consequences may vary with parent gender and country. Stillbirth can have devastating psychological, physical and social costs, with ongoing effects on interpersonal relationships and subsequently born children. However, parents who experience the tragedy of stillbirth can develop resilience and new life-skills and capacities. Future research should focus on developing interventions that may reduce the psychosocial cost of stillbirth. Electronic supplementary material The online version of this article (doi:10.1186/s12884-016-0800-8) contains supplementary material, which is available to authorized users.

Background Compared to other pregnancy-related events, the full cost of stillbirth remains poorly described. In the UK one in every 200 births ends in stillbirth. As a follow-up to a recent study which explored the direct costs of stillbirth, this study aimed to explore the intangible costs of stillbirth in terms of their duration and economic implication. Methods Systematic searches identified relevant papers on the psychological consequences of stillbirth. A narrative review of the quantitative studies was undertaken. This was followed by a qualitative synthesis using meta-ethnography to identify over-arching themes common to the papers. Finally, the themes were used to generate questions proposed for use in a questionnaire to capture the intangible costs of stillbirth. Results The narrative review revealed a higher level of anxiety and depression in couples with stillbirth compared to those without stillbirth. The qualitative synthesis identified a range of psychological effects common to families that have experienced stillbirth. Both methods revealed the persistent nature of these effects and the subsequent economic burden. Conclusions The psychological effects of stillbirth adversely impacts on the daily functioning, relationships and employment of those affected with far-reaching economic implications. Knowledge of the intangible costs of stillbirth is therefore important to accurately estimate the size of the impact on families and health services and to inform policy and decision making. Electronic supplementary material The online version of this article (doi:10.1186/s12884-015-0617-x) contains supplementary material, which is available to authorized users.

Background: Stillbirth occurring after 28 weeks gestation affects between 1.5-4.5 per 1,000 births in high-income countries. The majority of stillbirths in this setting occur in women without risk factors. In addition, many established risk factors such as nulliparity and maternal age are not amenable to modification during pregnancy. Identification of other risk factors which could be amenable to change in pregnancy should be a priority in stillbirth prevention research. Therefore, this study aimed to utilise an online survey asking women who had a stillbirth about their pregnancy in order to identify any common symptoms and experiences. Methods: A web-based survey. Results: A total of 1,714 women who had experienced a stillbirth >3 weeks prior to enrolment completed the survey. Common experiences identified were: perception of changes in fetal movement (63 % of respondents), reports of a "gut instinct" that something was wrong (68 %), and perceived time of death occurring overnight (56 %). A quarter of participants believed that their baby's death was due to a cord issue and another 18 % indicated that they did not know the reason why their baby died. In many cases (55 %) the mother believed the cause of death was different to that told by clinicians. Conclusions: This study confirms the association between altered fetal movements and stillbirth and highlights novel associations that merit closer scrutiny including a maternal gut instinct that something was wrong. The potential importance of maternal sleep is highlighted by the finding of more than half the mothers believing their baby died during the night. This study supports the importance of listening to mothers' concerns and symptoms during pregnancy and highlights the need for thorough investigation of stillbirth and appropriate explanation being given to parents.

The United Kingdom has one of the highest rates of stillbirth in Europe, resulting in approximately 4,000 stillbirths every year. Potentially modifiable risk factors for late stillbirths are maternal age, obesity and smoking, but the population attributable risk associated with these risk factors is small.Recently the Auckland Stillbirth Study reported that maternal sleep position was associated with late stillbirth. Women who did not sleep on their left side on the night before the death of the baby had double the risk compared with sleeping on other positions. The population attributable risk was 37%. This novel observation needs to be replicated or refuted.Methods/design: Case control study of late singleton stillbirths without congenital abnormality. Controls are women with an ongoing singleton pregnancy, who are randomly selected from participating maternity units booking list of pregnant women, they are allocated a gestation for interview based on the distribution of gestations of stillbirths from the previous 4 years for the unit. The number of controls selected is proportional to the number of stillbirths that occurred at the hospital over the previous 4 years.Data collection: Interviewer administered questionnaire and data extracted from medical records. Sample size: 415 cases and 830 controls. This takes into account a 30% non-participation rate, and will detect an OR of 1.5 with a significance level of 0.05 and power of 80% for variables with a prevalence of 57%, such as non-left sleeping position.Statistical analysis: Mantel-Haenszel odds ratios and unconditional logistic regression to adjust for potential confounders. DISCUSSION: The hypotheses to be tested here are important, biologically plausible and amenable to a public health intervention. Although this case-control study cannot prove causation, there is a striking parallel with research relating to sudden infant death syndrome, where case-control studies identified prone sleeping position as a major modifiable risk factor. Subsequently mothers were advised to sleep babies prone ("Back to Sleep" campaign), which resulted in a dramatic drop in SIDS. This study will provide robust evidence to help determine whether such a public health intervention should be considered.Trial registration number: http://clinicaltrials.gov/ct2/show/NCT02025530.

Background Women presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction. These outcomes after RFM are related to smaller fetal size on ultrasound scan, oligohydramnios and lower human placental lactogen (hPL) in maternal serum. We performed this study to address whether a randomised controlled trial (RCT) of the management of RFM was feasible with regard to: i) maternal recruitment and retention ii) patient acceptability, iii) adherence to protocol. Additionally, we aimed to confirm the prevalence of poor perinatal outcomes defined as: stillbirth, birthweight

The association between a reduction in fetal movements (RFM) and stillbirth has been noted for at least 450 years. This was formalised from the 1970s onwards in a series of studies that noted the increased incidence of stillbirth and FGR in women presenting with RFM, which in some cases preceded intrauterine fetal death by several days. Interpretation of the literature relating RFM to stillbirth and FGR is complicated by differences in studies’ definitions of RFM and FGR [1]. Nevertheless, the association between RFM and stillbirth remains, irrespective of the definitions used. Recently, the Auckland Stillbirth Study confirmed that women who had a RFM were 2.4 times (95% CI 1.29-4.35) more likely to have a late stillbirth [2], which is strikingly similar to a UK-based study which found a 3-fold increase in stillbirth after one presentation with RFM [3]. RFM, FGR and stillbirth are thought to be related by placental insufficiency, with RFM representing fetal compensation to restriction of nutrients and oxygen in utero [4,5]. This hypothesis is supported by evidence of abnormal placental structure and amino acid transport in women with RFM, even in the absence of a small-for-gestational age fetus [6]. Despite the association between RFM and stillbirth, RFM is frequently suboptimally managed clinically. Of 422 stillbirths reviewed in a confidential enquiry, 16.4% of cases had suboptimal care related to RFM, including: not communicating the importance of RFM to mothers and a failure to act on RFM [7]. Reasons for clinicians’ behaviour have been explored by two related questionnaire studies, one in the UK and one in Australia and New Zealand. Both of these studies found significant variations in the definitions of RFM applied to clinical practice and varied knowledge of the association between RFM, FGR and stillbirth. As a consequence clinical management of women with RFM varied significantly, with cardiotocography being used in 80-90% of cases and ultrasound assessment of fetal growth, liquor volume and umbilical artery Doppler in approximately 20% of cases [8,9]. Due to the association between RFM, FGR and stillbirth, ultrasound assessment of fetal growth, liquor volume and umbilical artery Doppler may be useful screening tests to identify placental insufficiency [10]. Norwegian studies have suggested that asking women to be more aware of fetal movements did not increase the number of attendances with RFM. Importantly, the implementation of an associated quality-improvement programme was associated with increased use of ultrasound, but a reduction of stillbirth from 4.2% to 2.4% [11], strongly suggesting that appropriate identification of, and intervention following, RFM may decrease the incidence of stillbirth. The management of RFM may be improved by more sensitive tests to specifically identify placental dysfunction, including measurement of placentally-derived factors such as human placental lactogen or placental growth factor [12,13]. The use of RFM as a screening tool for stillbirth prevention needs to be developed; it has the advantages that it is free and does not significantly increase the burden on the antenatal service. However, the best management protocol after women present with RFM has yet to be determined. To date there have been no randomised controlled trials of the management of RFM, despite calls from the World Health Organisation to improve the quality of evidence regarding stillbirth prevention [14]. Therefore, a high-quality trial is needed to evaluate whether intervention (delivery) directed by appropriate investigations after RFM can reduce the incidence of late stillbirth, without significantly increasing maternal and perinatal morbidity.