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Background: Despite international clinical guideline recommendations, implementation of Bayes-theorem based preeclampsia risk prediction model in first trimester among Chinese women is limited. The aim of this study is to examine the effectiveness of this risk predictive strategy in reducing the risk of preeclampsia.Methods: The study will be a randomized, stepped-wedge controlled trial conducted in eighteen hospitals in China. Stepped implementation of Bayes-theorem based risk prediction model will be delivered to hospitals in a random order to support the introduction of this prediction model of preeclampsia. A staged process will be undertaken to develop the risk prediction strategies, which comprise of: combined risk evaluation by maternal risk factors, medium arterial pressure, uterine artery pulse index and placenta growth factor during 11-13+6 gestational weeks, monthly follow up (including blood pressure, newly onset complications, adherence to aspirin). Repeated cross-sectional outcome data will be gathered weekly across all hospitals for the study duration. The primary outcome measures are the incidence of preeclampsia within 42 days postpartum. Data on resources expended during intervention development and implementation will be collected. The incidence of pregnancy related complications will be measured as secondary outcomes.Discussion: This will be the first randomized controlled trial to evaluate the effectiveness of the Bayes-theorem based preeclampsia risk prediction strategies in first trimester by competing risk model validation. If positive changes in clinical practice are found, this evidence will support health service adoption of this risk prediction model to reduce the risk of preeclampsia among Chinese pregnant women.Trial Registration: Chinese Clinical Trials Registry, No. ChiCTR2100043520 (date registered:21/2/2021). [ABSTRACT FROM AUTHOR]

Background: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services.Methods: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness.Results: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable.Conclusions: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support.Trial Registration: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true. [ABSTRACT FROM AUTHOR]

Background: Many adverse pregnancy outcomes in the UK could be prevented with better intrapartum care. Training for intrapartum emergencies has been widely recommended but there are conflicting data about their effectiveness. Observational studies have shown sustained local improvements in perinatal outcomes associated with the use of the PRactical Obstetric Multi-Professional Training - (PROMPT) training package. However this effect needs to be investigated in the context of randomised study design in settings other than enthusiastic early adopter single-centres. The main aim of this study is to determine the effectiveness of PROMPT to reduce the rate of term infants born with low APGAR scores.Methods: THISTLE (Trial of Hands-on Interprofessional Simulation Training for Local Emergencies) is a multi-centre stepped-wedge clustered randomised controlled superiority trial conducted across 12 large Maternity Units in Scotland. On the basis of prior observational findings all Units have been offered the intervention and have been randomly allocated in groups of four Units, to one of three intervention time periods, each six months apart. Teams of four multi-professional clinicians from each participating Unit attended a two-day PROMPT Train the Trainers (T3) programme prior to the start of their allocated intervention step. Following the T3 training, the teams commenced the implementation of local intrapartum emergency training in their own Units by the start of their allocated intervention period. Blinding has not been possible due to the nature of the intervention. The aim of the study is to follow up each Unit for at least 12-months after they have commenced their local courses. The primary outcome for the study is the proportion of Apgar scores <7 at 5 min for term vaginal or emergency caesarean section births (≥37 weeks) occurring in each of the study Units. These data will be extracted from the Information Services Division Scottish Morbidity Record 02, a national routine data collection on pregnancy and births. Mixed or marginal logistic regression will be employed for the main analysis.Discussion: THISTLE is the first stepped wedge cluster randomised trial to evaluate the effectiveness of an intrapartum emergencies training programme. The results will inform training, trainers and policy going forward.Trial Registration: ISRCTN11640515 (registered on 09/09/2013). [ABSTRACT FROM AUTHOR]