Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

NCT04766866.

Work-related stress is a social determinant of global health that represents a huge cost to workers’ health and reduces work performance. In Australia, mental well-being is a pressing national issue—with one in five Australians experiencing mental disorders. Antidepressants are a first-line medication commonly used to treat mental disorders. Recently, Australia has seen a dramatic increase in the use of prescribed antidepressant medications to treat mental health related illnesses. Australia has also seen a dramatic increase in the use of prescribed opioid analgesics for non-cancer pain including opioid use for psychological distress and social stressors. It is plausible a rise in mental health problems and antidepressant and opioid medication use is partly attributable to the corporate climate for worker mental health (ie, the psychosocial safety climate, PSC). This research aims to identify how PSC and workplace conditions contribute to employee well-being and distress that culminate in antidepressant and opioid medication use.

Data will be collected through creative data linkage from the Australian Workplace Barometer (AWB), to medication data (via the Pharmaceutical Benefits Scheme, PBS). The participant sample will include 1372 working Australians from the AWB project from 2009 to 2021. Four waves of longitudinal data from 2009 to 2021 will be used to investigate the plausible link between Australia’s high levels of antidepressant and opioid use and distress at work. The project advances theory by probing the role corporate climate plays in work design, distress, mental health problems and antidepressant and opioid use. It will determine if antidepressant and opioid use has led to an underestimation of work stress effects. Proposed theoretical models will be analysed through linked data, using continuous time structural equation modelling, hierarchical linear modelling, logistic regression and cost estimation.

The study has been approved by the Human Research Ethics Committee of the University of South Australia (Ethics Protocol: 203003). Further, approval from the Australian Institute of Health and Welfare Ethics Committee was also granted for linkage of AWB data and PBS data (EthOS Application EO2022/1/1190).

Results of the study will be disseminated through worldwide keynotes, key international settings, high-impact peer-reviewed journals, industry conference presentations and media outlets to reach managers, workers, and industry partners. Further, UniSA requires publications from public projects to be held in an institutional repository which fulfils the Australian Research Council’s Open Access Policy.