Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

BACKGROUND: Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS: A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS: Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended. CONCLUSIONS: Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. TRIAL REGISTRATION: Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474

Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol

Introduction: Following the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years. Methods and analysis: Women with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is <10th percentile or has decreased by 50 percentiles since 18-32 weeks will be included for observational data collection. Participants will be randomised if cerebral blood flow redistribution is identified, based on umbilical to middle cerebral artery pulsatility index ratio values. Computerised cardiotocography (cCTG) must show normal fetal heart rate short term variation (≥4.5 msec) and absence of decelerations at randomisation. Randomisation will be 1:1 to immediate delivery or delayed delivery (based on cCTG abnormalities or other worsening fetal condition). The primary outcome is poor condition at birth and/or fetal or neonatal death and/or major neonatal morbidity, the secondary non-inferiority outcome is 2-year infant general health and neurodevelopmental outcome based on the Parent Report of Children's Abilities-Revised questionnaire. Ethics and dissemination: The Study Coordination Centre has obtained approval from London-Riverside Research Ethics Committee (REC) and Health Regulatory Authority (HRA). Publication will be in line with NIHR Open Access policy. Trial registration number: Main sponsor: Imperial College London, Reference: 19QC5491. Funders: NIHR HTA, Reference: 127 976. Study coordination centre: Imperial College Healthcare NHS Trust, Du Cane Road, London, W12 0HS with Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University. IRAS Project ID: 266 400. REC reference: 20/LO/0031. ISRCTN registry: 76 016 200

Uplift mechanics of unanchored liquid storage tanks subjected to lateral earthquake loading

Motivated by the seismic response of unanchored liquid storage tanks, their uplift mechanism under strong lateral loading is examined. Using three-dimensional finite element models, nonlinear static analysis is conducted to define the moment-rotation relationship of uplifting tanks resting on rigid foundation and describe the evolution of critical response parameters with increasing level of lateral loading. Meridional and hoop stress, as well as their distribution and evolution with increased uplift are computed. Comparing the numerical results with the corresponding results from anchored tanks, striking differences are observed on the values of compressive meridional stresses and their distribution around the tank circumference. Cyclic analysis, associated with repeated uplift at both sides of the tank, is also performed, to obtain the corresponding hysteretic response and verify the assumption of nonlinear-elastic tank behaviour, used in several previous works. Finally, an analytical solution is developed, capable of describing tank uplift in an efficient manner. The analytical solution accounts for the special features of uplift, obtained from the finite element solution, and can be used for simple and reliable assessment of seismic performance in unanchored liquid storage tanks

Systolic, Diastolic and Mean Arterial Pressure at 30-33 Weeks in the Prediction of Preeclampsia

&lt;b&gt;&lt;i&gt;Objective:&lt;/i&gt;&lt;/b&gt; To investigate the potential value of measuring mean arterial pressure (MAP), systolic (sBP) and diastolic (dBP) blood pressure at 30-33 weeks' gestation in the prediction of preeclampsia (PE) developing at or after 34 weeks. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Screening study in singleton pregnancies at 30-33 weeks' gestation including 4,294 that were unaffected by PE, gestational hypertension (GH) or delivery of small-for-gestational-age neonates (normal group), 145 that subsequently developed PE [37 cases requiring delivery at 34-37 weeks (intermediate PE) and 108 delivering at or after 38 weeks (late PE)] and 161 that developed GH. The a priori risks for intermediate and late PE from maternal demographic characteristics and medical history were determined. The a posteriori risks were calculated by combining the a priori risks with the likelihood ratios for MAP, sBP and dBP, which were calculated from fitted bivariate gaussian distributions. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; The mean multiple of median MAP, sBP and dBP were significantly higher in the intermediate and late PE groups than in the normal group. In screening by a combination of maternal characteristics and MAP, the estimated detection rates of intermediate and late PE, at a false-positive rate of 10%, were 70.3 and 62.0%, respectively. The respective detection rates for sBP were 62.2 and 59.3% and for dBP were 62.2 and 57.4%. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; Combined testing by maternal characteristics and blood pressure at 30-33 weeks could effectively identify women at high risk for subsequent development of PE.</jats:p