Background Pregnant women with metabolic risk factors are at high risk of complications. We aimed to assess whether a Mediterranean-style diet reduces adverse pregnancy outcomes in high-risk women. Methods and findings We conducted a multicentre randomised trial in 5 maternity units (4 in London and 1 in Birmingham) between 12 September 2014 and 29 February 2016. We randomised inner-city pregnant women with metabolic risk factors (obesity, chronic hypertension, or hypertriglyceridaemia) to a Mediterranean-style diet with high intake of nuts, extra virgin olive oil, fruits, vegetables, nonrefined grains, and legumes; moderate to high consumption of fish; low to moderate intake of poultry and dairy products; low intake of red and processed meat; and avoidance of sugary drinks, fast food, and food rich in animal fat versus usual care. Participants received individualised dietary advice at 18, 20, and 28 weeks’ gestation. The primary endpoints were composite maternal (gestational diabetes or preeclampsia) and composite offspring (stillbirth, small for gestational age, or admission to neonatal care unit) outcomes prioritised by a Delphi survey. We used an intention-to-treat (ITT) analysis with multivariable models and identified the stratification variables and prognostic factors a priori. We screened 7,950 and randomised 1,252 women. Baseline data were available for 593 women in the intervention (93.3% follow-up, 553/593) and 612 in the control (95.6% follow-up, 585/612) groups. Over a quarter of randomised women were primigravida (330/1,205; 27%), 60% (729/1,205) were of Black or Asian ethnicity, and 69% (836/1,205) were obese. Women in the intervention arm consumed more nuts (70.1% versus 22.9%; adjusted odds ratio [aOR] 6.8, 95% confidence interval [CI] 4.3–10.6, p ≤ 0.001) and extra virgin olive oil (93.2% versus 49.0%; aOR 32.2, 95% CI 16.0–64.6, p ≤ 0.001) than controls; increased their intake of fish ( p < 0.001), white meat ( p < 0.001), and pulses ( p = 0.05); and reduced their intake of red meat ( p < 0.001), butter, margarine, and cream ( p < 0.001). There was no significant reduction in the composite maternal (22.8% versus 28.6%; aOR 0.76, 95% CI 0.56–1.03, p = 0.08) or composite offspring (17.3% versus 20.9%; aOR 0.79, 95% CI 0.58–1.08, p = 0.14) outcomes. There was an apparent reduction in the odds of gestational diabetes by 35% (aOR 0.65, 95% CI 0.47–0.91, p = 0.01) but not in other individual components of the composite outcomes. Mothers gained less gestational weight (mean 6.8 versus 8.3 kg; adjusted difference −1.2 Kg, 95% CI −2.2 to −0.2, p = 0.03) with intervention versus control. There was no difference in any of the other maternal and offsprin...

This a preprint and has not been peer reviewed. Data may be preliminary.

Purpose The purpose of this paper is to provide quantitative estimates on the impact of active labour market policy (ALMP) on youth unemployment in Europe based on a macroeconomic panel data set of youth unemployment, ALMP and education policy variables and further country-specific characteristics on labour market institutions and the broader demographic and macroeconomic environment for all EU-Member States. Design/methodology/approach The authors follow the design of an aggregate impact analysis, which aims to explain the impact of policy on macroeconomic variables like youth employment and unemployment (see Bellmann and Jackman, 1996). This follows the assumption that programmes, which are effective in terms of improving individual employment opportunities, are going to make a difference on the equilibrium of youth unemployment. Findings The findings show that both wage subsidies and job creation are reducing aggregate youth unemployment, which is in contrast to some of the surveys of microeconomic studies indicating that job creation schemes are not effective. This finding points towards the importance to assist young people making valuable work experience, which is a benefit from job creation, even if this experience is made outside regular employment and/or the commercial sector. Research limitations/implications In terms of the variables to model public policy intervention in the youth labour market, only few indicators exist, which are consistently available for all EU-Member States, despite much more interest and research aiming to provide an exhaustive picture of the youth labour market in Europe. The only consistently available measures are spending on ALMP as a percentage of gross domestic product (in the different programmes) and participation stocks and entries by type of intervention. Practical implications The different effects found for the 15–19 year olds, who seem to benefit from wage subsidies, compared to the effect of job creations benefitting the 20–24 year olds, might relate to the different barriers for both groups to find employment. Job creation programmes seem to offer this group an alternative mechanism to gain valuable work experience outside the commercial sector, which could help form a narrative of positive labour market experience. In this way, job creation should be looked more positively at when further developing ALMP provision, especially for young people relatively more distant to engagement in regular employment. Social implications Improving the situation of many millions of young Europeans failing to find gainful employment, and more generally suffering from deprivation and social exclusion, has been identified as a clear priority for policy both at the national level of EU-Member States and for EU-wide initiatives. With this study, the authors attempt to contribute to the debate about the effectiveness of policies which combat youth unemployment by estimating the quantitative relationship of ALMP and other institutional features and youth unemployment. Originality/value To research the relationship between youth unemployment and ALMP, the authors created a macroeconomic database with repeated observations for all EU-Member States for a time series (1998–2012). The authors include variables on country demographics and the state of the economy as well as variables describing the labour market regimes from Eurostat, i.e. the flexibility of the labour market (part-time work and fixed-term employment as a percentage of total employment) and the wage setting system (level and coordination of bargaining and government intervention in wage bargaining).

There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent, leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment was 32% (95%CI 23-41%) in the intervention group vs. 81% (95%CI 70-90%) in the control group. The proportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control (31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference À0.6 units, 95%CI À1.2 to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3-1.1); and intensive care admissions (odds ratio 0.4, 95%CI 0.1-1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation.

IntroductionUp to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.Methods and analysisOptimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.Ethics and disseminationThe OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie’s Team) and through social media platforms.Trial registration numberISRCTN20930880