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Background Open Disclosure (OD) is open and timely communication about harmful events arising from health care with those affected. It is an entitlement of service-users and an aspect of their recovery, as well as an important dimension of service safety improvement. Recently, OD in maternity care in the English National Health Service has become a pressing public issue, with policymakers promoting multiple interventions to manage the financial and reputational costs of communication failures. There is limited research to understand how OD works and its effects in different contexts. Methods Realist literature screening, data extraction, and retroductive theorisation involving two advisory stakeholder groups. Data relevant to families, clinicians, and services were mapped to theorise the relationships between contexts, mechanisms, and outcomes. From these maps, key aspects for successful OD were identified. Results After realist quality appraisal, 38 documents were included in the synthesis (22 academic, 2 training guidance, and 14 policy report). 135 explanatory accounts were identified from the included documents (with n = 41 relevant to families; n = 37 relevant to staff; and n = 37 relevant to services). These were theorised as five key mechanism sets: (a) meaningful acknowledgement of harm, (b) opportunity for family involvement in reviews and investigations, (c) possibilities for families and staff to make sense of what happened, (d) specialist skills and psychological safety of clinicians, and (e) families and staff knowing that improvements are happening. Three key contextual factors were identified: (a) the configuration of the incident (how and when identified and classified as more or less severe); (b) national or state drivers, such as polices, regulations, and schemes, designed to promote OD; and (c) the organisational context within which these these drivers are recieived and negotiated. Conclusions This is the first review to theorise how OD works, for whom, in what circumstances, and why. We identify and examine from the secondary data the five key mechanisms for successful OD and the three contextual factors that influence this. The next study stage will use interview and ethnographic data to test, deepen, or overturn our five hypothesised programme theories to explain what is required to strengthen OD in maternity services.

Matters Arising article, arising from H. Bové et al. Nature Communications https://doi.org/10.1038/s41467-019-11654-3 (2019).

Summary: We compared bone outcomes in adolescents with breech and cephalic presentation. Tibia bone mineral content, density, periosteal circumference, and cross-sectional moment of inertia were lower in breech presentation, and females with breech presentation had lower hip CSA. These findings suggest that prenatal loading may exert long-lasting influences on skeletal development. Introduction: Breech position during pregnancy is associated with reduced range of fetal movement, and with lower limb joint stresses. Breech presentation at birth is associated with lower neonatal bone mineral content (BMC) and area, but it is unknown whether these associations persist into later life. Methods: We examined associations between presentation at onset of labor, and tibia and hip bone outcomes at age 17 years in 1971 participants (1062 females) from a UK prospective birth cohort that recruited > 15,000 pregnant women in 1991–1992. Cortical BMC, cross-sectional area (CSA) and bone mineral density (BMD), periosteal circumference, and cross-sectional moment of inertia (CSMI) were measured by peripheral quantitative computed tomography (pQCT) at 50% tibia length. Total hip BMC, bone area, BMD, and CSMI were measured by dual-energy X-ray absorptiometry (DXA). Results: In models adjusted for sex, age, maternal education, smoking, parity, and age, singleton/multiple births, breech presentation (n = 102) was associated with lower tibial cortical BMC (− 0.14SD, 95% CI − 0.29 to 0.00), CSA (− 0.12SD, − 0.26 to 0.02), BMD (− 0.16SD, − 0.31 to − 0.01), periosteal circumference (− 0.14SD, − 0.27 to − 0.01), and CSMI (− 0.11SD, − 0.24 to 0.01). In females only, breech presentation was associated with lower hip CSA (− 0.24SD, − 0.43 to 0.00) but not with other hip outcomes. Additional adjustment for potential mediators (delivery method, birthweight, gestational age, childhood motor competence and adolescent height and body composition) did not substantially affect associations with either tibia or hip outcomes. Conclusions: These findings suggest that prenatal skeletal loading may exert long-lasting influences on skeletal size and strength but require replication.

Background Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by the measurement of a placental biomarker in addition to standard care was feasible and improved pregnancy outcome compared with standard care alone. Methods Women aged 16–50 years presenting at eight UK maternity units with RFM between 36+0 and 41+0 weeks’ gestation with a viable singleton pregnancy and no indication for immediate delivery were eligible. Participants were randomised 1:1 in an unblinded manner to standard care and a biomarker blood test result revealed and acted on (intervention arm) or standard care where the biomarker result was not available (control arm). The objectives were to determine the feasibility of a main trial by recruiting 175–225 participants over 9 months and to provide proof of concept that informing care by measurement of placental biomarkers may improve outcome. Feasibility was assessed via the number of potentially eligible women, number recruited, reasons for non-recruitment and compliance. Proof of concept outcomes included the rates of the induction of labour and caesarean birth, and a composite adverse pregnancy outcome. Results Overall, 2917 women presented with RFM ≥ 36 weeks, 352 were approached to participate and 216 (61%) were randomised (intervention n = 109, control n = 107). The main reason for not approaching women was resource/staff issues (n = 1510). Ninety-seven women declined the trial, mainly due to not liking blood tests (n = 24) or not wanting to be in a trial (n = 21). Compliance with the trial interventions was 100% in both arms. Labour was induced in 97 (45%) participants (intervention n = 49, control n = 48), while 17 (9%) had planned caesarean sections (intervention n = 9, control n = 8). Overall, 9 (8%) babies in the intervention arm had the composite adverse pregnancy outcome versus 4 (4%) in the control arm. Conclusions A main trial using a placental biomarker in combination with delivery, as indicated by the biomarker, in women with RFM is feasible. The frequency of adverse outcomes in this population is low, hence, a large sample size would be required along with consideration of the most appropriate outcome measures. Trial registration ISRCTN, ISRCTN12067514; registered 8 September 2017.

Diabetes mellitus (DM) during pregnancy can result in fetal overgrowth, likely due to placental dysfunction, which has health consequences for the infant. Here we test our prediction from previous work using a placental cell line that high glucose concentrations affect placental lipid metabolism. Placentas from women with type 1 (n = 13), type 2 (n = 6) or gestational (n = 12) DM, BMI-matched to mothers without DM (n = 18), were analysed for lipase and fatty acid transport proteins and fatty acid and triglyceride content. Explants from uncomplicated pregnancies (n = 6) cultured in physiological or high glucose were similarly analysed. High glucose levels did not alter placental lipase or transporter expression or the profile and abundance of fatty acids, but triglyceride levels were higher (p

Background Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is related to abnormal placental structure and function. The ultimate objective of this trial is to assess whether for women with RFM, intervention directed by measurement of placental biochemical factors in addition to standard care improves pregnancy outcome compared with standard care alone. This is the protocol for a pilot trial to determine the feasibility of a definitive trial and also provide proof of concept that informing care by measurement of placental factors improves neonatal outcomes. Methods ReMIT-2 is a multicentre, pilot randomised controlled trial of care informed by results of an additional placental factor blood test versus standard care alone for women presenting with RFM at or after 36+ 0 weeks gestation. Participants will be randomised 1:1 to the intervention arm where the blood test result is revealed and acted on, or to the control arm where the blood sample is not tested immediately and therefore the result cannot be acted on. All participants will be followed up six weeks after delivery to assess their health status and views of the trial, along with healthcare costs. A sub-group will be interviewed within 16 weeks after delivery to further explore their views of the trial. Outcomes to determine feasibility of a definitive trial include number of potentially eligible women, proportion lost to follow-up, clinical characteristics at randomisation, reasons for non-recruitment, compliance with the trial intervention and views of participants and clinicians about the trial. Proof of concept outcomes include: rates of induction of labour; Caesarean birth; and a composite neonatal outcome of stillbirths and deaths before discharge, 5-min Apgar score 48 h. Discussion Results from this pilot trial will help determine whether a large definitive trial is feasible. Such a study would provide evidence to guide management of women with RFM and reduce stillbirths. Trial registration ISRCTN Registry, ISRCTN12067514. Registered on 8 September 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2859-1) contains supplementary material, which is available to authorized users.

${\bf Background}$ Despite the global burden of perinatal deaths, there is currently no single, globally-acceptable classification system for perinatal deaths. Instead, multiple, disparate systems are in use world-wide. This inconsistency hinders accurate estimates of causes of death and impedes effective prevention strategies. The World Health Organisation (WHO) is developing a globally-acceptable classification approach for perinatal deaths. To inform this work, we sought to establish a consensus on the important characteristics of such a system. ${\bf Methods}$ A group of international experts in the classification of perinatal deaths were identified and invited to join an expert panel to develop a list of important characteristics of a quality global classification system for perinatal death. A Delphi consensus methodology was used to reach agreement. Three rounds of consultation were undertaken using a purpose built on-line survey. Round one sought suggested characteristics for subsequent scoring and selection in rounds two and three. ${\bf Results}$ The panel of experts agreed on a total of 17 important characteristics for a globally-acceptable perinatal death classification system. Of these, 10 relate to the structural design of the system and 7 relate to the functional aspects and use of the system. ${\bf Conclusion}$ This study serves as formative work towards the development of a globally-acceptable approach for the classification of the causes of perinatal deaths. The list of functional and structural characteristics identified should be taken into consideration when designing and developing such a system., This project was initially undertaken as part of the Harmonized Reproductive Health Registries project through the Norwegian Institute of Public Health in Partnership with the Mater Medical Research Institute, Brisbane, Australia, and in collaboration with the Department of Reproductive Health and Research, WHO., This is the author accepted manuscript. It is currently under an indefinite embargo pending publication by BioMed Central.

Unique biochemical and physical challenges to both mother and fetus are observed during human pregnancy, and the placenta plays an important role in protecting the fetus and supporting its development. Consequently, many pregnancy complications are associated with altered placental biochemistry and structure. Here we have further developed a combination of analytical tools for determining the tissue metabolome of placental tissue by applying a methanol/water/chloroform extraction method followed by analysis of the polar fraction (methanol/water) using GC–ToF–MS and of the non-polar fraction (chloroform) using UPLC–LTQ–Orbitrap–MS. This combination maximises the number of different metabolites detected and is the first holistic investigation of placental tissue applying UPLC–MS. Placental tissue differs between early and late first trimester pregnancies in that the developing placenta is exposed to significantly different oxygen tensions and undergoes a change from histiotrophic to haemotrophic nutrition. Application of these metabolomic methods detected 156 unique and chemically identified metabolites that showed statistically significant differences (P

Apoptosis within villous trophoblast is increased in pregnancies complicated by pre-eclampsia (PE). Caspase activity is regulated by the balance of inhibitors of apoptosis proteins (IAPs). This study investigated the expression and localisation of smac, HtrA2/Omi and IAPs in villous trophoblast in normal pregnancies and those complicated by PE. smac was significantly elevated in PE compared to normal pregnancies and staining was evident in syncytiotrophoblast (ST), cytotrophoblast (CT) and endothelial cells. Weak staining for HtrA2/Omi was present in ST cytoplasm in both normal and PE pregnancies. XIAP and survivin were not altered in PE. XIAP localized to ST cytoplasm, with weak staining in CT. Survivin localized to ST and CT cytoplasm, but also CT nuclei. In non-placental cells increased smac expression in the presence of normal IAP expression induces apoptosis. In conclusion, the increased expression of smac in villous trophoblast may have a role in increased apoptosis in PE.

Multiple studies using various approaches have associated reduced fetal movements (RFM) with stillbirth and small for gestational age infants [1,2]. More recently, RFM has been linked to neurodevelopmental delay and a lack of response to treatment for hypoxic-ischaemic encephalopathy [3,4]. The relationship between adverse pregnancy or infant outcome is thought to be mediated by placental dysfunction [5]; thus RFM represents a symptom of placental insufficiency, when a placenta cannot meet the metabolic demands of the growing fetus. This hypothesis is now supported by evidence of changes in placental structure, inflammation and function in women who present with RFM [6,7]. Critically, some of these changes in placental size, structure and pathology differentiate between pregnancies with RFM that end in healthy pregnancy or adverse outcomes [8,9]. Thus, assessment of fetal growth and placental function in mothers presenting with RFM may offer new avenues to identify babies at risk of stillbirth to target intervention. A prospective control study found that 67 out of 303 women (22%) presenting with RFM to St Mary’s Hospital, Manchester, UK had adverse perinatal outcome. Significant predictors of adverse outcome were diastolic blood pressure, estimated weight centile, liquor volume and log[human placental lactogen (hPL)] [10]. Four cases had abnormalities on cardiotocography and 20 cases had abnormal ultrasound findings and 24 had an hPL

BACKGROUND: The development of evidence-based guidelines is a key step in ensuring that maternity care is of a universally high standard. To influence patient care national and international guidelines need to be interpreted and implemented locally. In 2011, the Royal College of Obstetricians and Gynaecologists published guidelines for the management of reduced fetal movements (RFM), which can be an important symptom of fetal compromise. Following dissemination it was anticipated that this guidance would be implemented in UK maternity units. This study aimed to assess the quality of local guidelines for the management of RFM in comparison to published national standards. METHODS: Cross-sectional survey of maternity unit guidelines for RFM. The guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE) II Tool and scored by two independent investigators. Two national guidelines were used as standards to evaluate unit guidelines. RESULTS: Responses were received from 98 units (42%); 12 units had no guideline. National guidelines scored highly using the AGREE II tool but there was wide variation in the quality of individual maternity unit guidelines, which were frequently of low quality. No guidelines incorporated all the recommendations from the national guideline. Maternity unit guidelines performed well for clarity and presentation but had low scores for stakeholder involvement, rigour of development and applicability. CONCLUSIONS: In contrast to national evidence based guidance the quality of maternity unit guidelines for RFM is variable and frequently of low quality. To increase quality, guidelines need to include up to date evidence and audit standards which could be taken directly from national evidence-based guidance. Barriers to local implementation and resource implications need to be taken into consideration. Training may also improve the implementation of the guideline. Research is needed to inform strategies to realize the benefits of clinical guidance in practice.

Auscultation of the fetal heart is a common event in antenatal care, in early pregnancy it may be associated with false negative results, which require ultrasound scan to confirm fetal viability.We studied 197 women in early pregnancy to determine the gestational age at which the fetal heart can be reliably identified and the factors which determined the accuracy of the test.The proportion of successful auscultations increased with advancing gestation (p0.001). There was no effect of maternal body mass index or the level of midwifery experience.For a sensitivity of 90%, the fetal heart should be auscultated after 13 week gestation. If a sensitivity of 80% is acceptable the fetal heart can be auscultated after 12 + 1 week gestation.