Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment with ASpirin for evidence-based PREeclampsia prevention (ASPRE)

This is the final version of the article. Available from BMJ Publishing Group via the DOI in this record.INTRODUCTION: Pre-eclampsia (PE) affects 2-3% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Prophylactic use of low-dose aspirin in women at risk for PE may substantially reduce the prevalence of the disease. Effective screening for PE requiring delivery before 37 weeks (preterm PE) can be provided by a combination of maternal factors, uterine artery Doppler, mean arterial pressure, maternal serum pregnancy-associated plasma protein A and placental growth factor at 11-13 weeks' gestation, with a detection rate of 75% at a false-positive rate of 10%. We present a protocol (V.6, date 25 January 2016) for the ASpirin for evidence-based PREeclampsia prevention (ASPRE) trial, which is a double-blinded, placebo-controlled, randomised controlled trial (RCT) that uses an effective PE screening programme to determine whether low-dose aspirin given to women from 11 to 13 weeks' gestation will reduce the incidence of preterm PE. METHODS AND ANALYSIS: All eligible women attending for their first trimester scan will be invited to participate in the screening study for preterm PE. Those found to be at high risk of developing preterm PE will be invited to participate in the RCT. Further scans will be conducted for assessment of fetal growth and biomarkers. Pregnancy and neonatal outcomes will be collected and analysed. The first enrolment for the pilot study was in April 2014. As of April 2016, 26 670 women have been screened and 1760 recruited to the RCT. The study is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry. TRIAL REGISTRATION NUMBER: ISRCTN13633058.This study is supported by grants from the European Union 7th Framework Programme—FP7-HEALTH-2013-INNOVATION-2 (ASPRE Project # 601852) and the Fetal Medicine Foundation (FMF) (Charity No: 1037116)

Externally validated prediction models for pre‐eclampsia:systematic review and meta‐analysis

Objective: This systematic review and meta‐analysis aimed to evaluate the performance of existing externally validated prediction models for pre‐eclampsia (PE) (specifically, any‐onset, early‐onset, late‐onset and preterm PE). Methods: A systematic search was conducted in five databases (MEDLINE, EMBASE, Emcare, CINAHL and Maternity & Infant Care Database) and using Google Scholar/reference search to identify studies based on the Population, Index prediction model, Comparator, Outcome, Timing and Setting (PICOTS) approach until 20 May 2023. We extracted data using the CHARMS checklist and appraised the risk of bias using the PROBAST tool. A meta‐analysis of discrimination and calibration performance was conducted when appropriate. Results: Twenty‐three studies reported 52 externally validated prediction models for PE (one preterm, 20 any‐onset, 17 early‐onset and 14 late‐onset PE models). No model had the same set of predictors. Fifteen any‐onset PE models were validated externally once, two were validated twice and three were validated three times, while the Fetal Medicine Foundation (FMF) competing‐risks model for preterm PE prediction was validated widely in 16 different settings. The most common predictors were maternal characteristics (prepregnancy body mass index, prior PE, family history of PE, chronic medical conditions and ethnicity) and biomarkers (uterine artery pulsatility index and pregnancy‐associated plasma protein‐A). The FMF model for preterm PE (triple test plus maternal factors) had the best performance, with a pooled area under the receiver‐operating‐characteristics curve (AUC) of 0.90 (95% prediction interval (PI), 0.76–0.96), and was well calibrated. The other models generally had poor‐to‐good discrimination performance (median AUC, 0.66 (range, 0.53–0.77)) and were overfitted on external validation. Apart from the FMF model, only two models that were validated multiple times for any‐onset PE prediction, which were based on maternal characteristics only, produced reasonable pooled AUCs of 0.71 (95% PI, 0.66–0.76) and 0.73 (95% PI, 0.55–0.86). Conclusions: Existing externally validated prediction models for any‐, early‐ and late‐onset PE have limited discrimination and calibration performance, and include inconsistent input variables. The triple‐test FMF model had outstanding discrimination performance in predicting preterm PE in numerous settings, but the inclusion of specialized biomarkers may limit feasibility and implementation outside of high‐resource settings. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology

First Trimester Examination of Fetal Anatomy: Clinical Practice Guideline by the World Association of Perinatal Medicine (WAPM) and the Perinatal Medicine Foundation (PMF)

This recommendation document follows the mission of the World Association of Perinatal Medicine in collaboration with the Perinatal Medicine Foundation. We aim to bring together groups and individuals throughout the world for precise standardization to implement the ultrasound evaluation of the fetus in the first trimester of pregnancy and improve the early detection of anomalies and the clinical management of the pregnancy. The aim is to present a document that includes statements and recommendations on the standard evaluation of the fetal anatomy in the first trimester, based on quality evidence in the peer-reviewed literature as well as the experience of perinatal experts around the world.info:eu-repo/semantics/publishedVersio

Aspirin for evidence-based preeclampsia prevention trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and medical and obstetrical history.

Objective: To examine whether there are differences in the effect of aspirin on the incidence of preterm-PE in the ASPRE trial in subgroups defined according to maternal characteristics and medical and obstetrical history. Study design: This was a secondary analysis of data from the ASPRE trial. In ASPRE women with singleton pregnancies had screening by means of an algorithm that combines maternal factors and biomarkers at 11-13 weeks’ gestation. Those with an estimated risk for preterm-PE of >1 in 100 were invited to participate in a double-blind trial of aspirin (150 mg/day) vs. placebo from 11 to 14 until 36 weeks’ gestation. Aspirin was associated with a significant reduction in the incidence of preterm-PE with delivery at 90% of the prescribed medication. Results are presented as forest plot with P values for the interaction effects, group sizes, event counts and estimated odds ratios. We examined whether the test of interaction was significant at the 5% level with a Bonferroni adjustment for multiple comparisons. Results: There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history. In participants with chronic hypertension preterm-PE occurred in 10.2% (5/49) in the aspirin group and in 8.2% (5/61) in the placebo group (adjusted odds ratio 1.29, 95% confidence interval, 0.33 to 5.12); the respective values in those without chronic hypertension were 1.1% (8/749) in the aspirin group and 3.9% (30/761) in the placebo group (adjusted odds ratio 0.27, 95% confidence interval, 0.12 to 0.60). In all participants with adherence of >90% the adjusted odds ratio in the aspirin group was 0.24 (95% CI 0.09 to 0.65), in the subgroup with chronic hypertension it was 2.06 (95% CI 0.40 to 10.71) and in those without chronic hypertension it was 0.05 (95% CI 0.01 to 0.41). For the complete data set the test of interaction was not significant at the 5% level (p=0.055), but in those with adherence >90%, after adjustment for multiple comparisons, the interaction was significant at the 5% level (p=0.0019). Conclusions: The beneficial effect of aspirin in the prevention of preterm preeclampsia may not apply in pregnancies with chronic hypertension. There was no evidence of heterogeneity in the aspirin effect in subgroups defined according to maternal characteristics and obstetrical history

Screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation

Objective: To examine the performance of screening for early-, preterm- and term-preeclampsia (PE) at 11 13 weeks’ gestation by maternal factors and combinations of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PLGF) and serum pregnancy associated plasma protein A (PAPP A). Methods The data for this study were derived from three previously reported prospective non intervention screening studies at 11+0 – 13+6 weeks’ gestation in a combined total of 61,174 singleton pregnancies, including 1,770 (2.9%) that developed PE. Bayes theorem was used to combine the prior distribution of the gestational age at delivery with PE, obtained from maternal characteristics, with various combinations of biomarker multiple of the median (MoM) values to derive the p patient specific risks of delivery with PE at <37 weeks’ gestation. The performance of such screening was estimated. Results In pregnancies that develop ed PE , compared to those without PE, the MoM values of UtA-PI and MAP were increased and PAPP A and PLGF were decreased and the deviation from normal was greater for early than late PE for all four biomarkers. Combined screening by maternal factors, UtA-PI, MAP and PLGF predicted 90% of early PE, 75% of preterm PE and 4 1 % of term PE, at screen positive rate of 10%; inclusion of PAPP A did not improve the performance of screening The performance of screening depended on the racial origin of the women; in screening by a combination of maternal factors, MAP, UtA-PI and PLGF and use of the risk cut off of 1 in 10 0 for PE at <37 weeks in Caucasian women, the screen positive rate was 10% and detection rates for early --, preterm and term PE were 88%, 69% and 40%, respectively. With the same method of screening and risk cut off in women of Afro Caribbean racial origin, the screen positive rate was 34% and detection rates for early --, preterm and term PE were 100%, 92% and 75%, respectively. Conclusion Screening by maternal factors and biomarkers at 11-13 weeks’ gestation can identify a high proportion of pregnancies that develop early- and preterm-PE

From eviction to evicting: Rethinking the technologies, lives and power sustaining displacement

An unnamed shift has occurred in geographies of eviction. While past research focused on the causes and effects of eviction in political economy, state power, and cultural difference, emerging work emphasises the subjective experience and sustaining practices of eviction as it happens. This paper makes the case for this turn away from causes and outcomes of ‘eviction’, and towards ‘evicting’ as a set of material technologies and practices that sustain displacement, and explores the implications of such a shift. Research into lived durations of eviction, evicting technologies, and eviction enforcement agencies opens up new conceptual and political fields of intervention

‘Where are we when we think?’ Space, time and emancipatory education in galleries

Adult education in art galleries sits on a fault line, at once an apparatus upholding the affirmative aspects of museum culture cultivated by global elites, a propellant in the whirring of an increasingly dislocated set of events on trendy and consumable political themes, and a site for ‘allyship’ and other kinds of radical and socially transformative work. Resurrecting Hannah Arendt’s question,‘where are we when we think?’ this paper explores how we might move from a moment in which the ‘space’ of the gallery is replaced by the ‘time’ of the event (Helguera) and towards embedded space-times that attempt to address contemporary urgencies through situated practices that collectively analyse and respond to conditions. Drawn from examples derived from the author’s practice, the paper argues for the use of popular education and anti-colonial pedagogies in the production of adult education in galleries, suggesting that such processes support groups in collectively naming and thinking through conflicts to re-shape both the galleries in which they have congregated and the worlds beyond their doors. This paper suggests that the re-construction and use of the often forgotten genealogies of emancipatory education are pivotal to doing social justice work in galleries

Institutionalisation of Social Movements: Co-option And Democratic Policy-making

Over the past 30 years, urban policy in Brazil has undergone a major transformation, both in terms of regulatory frameworks and the involvement of citizens in the process of policy-making. As an intense process of institutional innovation and mobilisation for decent publicservices took place, academics started to consider the impact of institutionalisation on the autonomy of social movements. Using empirical evidence from a city in the northeast of Brazil, this article addresses the wider literature on citizen participation and social movements to examine specifically the problem with co-optation. I examine the risks linked to co-optation, risks that can undermine the credibility of social movements as agents of change, and explore the tensions that go beyond the ‘co-optation versus autonomy’ divide, an issue frequently found in the practices of social movements, in their dealings with those in power. In particular, this article explores the learning processes and contentious relationships between mainly institutionally oriented urban movements and local government. This study found that the learning of deliberative skills not only led to changes in the objectives and repertoires of housing movements, but also to the inclusion of new components in their objectives that provide room for creative agency and which, in some cases, might allow them to maintain their autonomy from the state

The quantified self: what counts in the neoliberal workplace

Implementation of quantified self technologies in workplaces relies on the ontological premise of Cartesian dualism with mind dominant over body. Contributing to debates in new materialism, we demonstrate that workers are now being asked to measure our own productivity and health and wellbeing in art-houses and warehouses alike in both the global north and south. Workers experience intensified precarity, austerity, intense competition for jobs, and anxieties about the replacement of labour-power with robots and other machines as well as, ourselves replaceable, other humans. Workers have internalized the imperative to perform, a subjectification process as we become observing, entrepreneurial subjects and observed, objectified labouring bodies. Thinking through the implications of the use of wearable technologies in workplaces, this article shows that these technologies introduce a heightened Taylorist influence on precarious working bodies within neoliberal workplaces