Study protocol for the Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI): a multicentre, cluster-randomised, parallel-group, superiority trial of a multifaceted community-family-mother-child intervention to prevent childhood overweight and obesity.

INTRODUCTION: Childhood overweight and obesity (OWO) is a primary global health challenge. Childhood OWO prevention is now a public health priority in China. The Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI), one of four trials being undertaken by the international HeLTI consortium, aims to evaluate the effectiveness of a multifaceted, community-family-mother-child intervention on childhood OWO and non-communicable diseases risk. METHODS AND ANALYSIS: This is a multicentre, cluster-randomised, controlled trial conducted in Shanghai, China. The unit of randomisation is the service area of Maternal Child Health Units (N=36). We will recruit 4500 women/partners/families in maternity and district level hospitals. Participants in the intervention group will receive a multifaceted, integrated package of health promotion interventions beginning in preconception or in the first trimester of pregnancy, continuing into infancy and early childhood. The intervention, which is centred on a modified motivational interviewing approach, will target early-life maternal and child risk factors for adiposity. Through the development of a biological specimen bank, we will study potential mechanisms underlying the effects of the intervention. The primary outcome for the trial is childhood OWO (body mass index for age ≥85th percentile) at 5 years of age, based on WHO sex-specific standards. The study has a power of 0.8 (α=0.05) to detect a 30% risk reduction in the proportion of children with OWO at 5 years of age, from 24.4% in the control group to 17% in the intervention group. Recruitment was launched on 30 August 2018 for the pilot study and 10 January 2019 for the formal study. ETHICS AND DISSEMINATION: The study has been approved by the Medical Research Ethics Committee of the International Peace Maternity and Child Health Hospital in Shanghai, China, and the Research Ethics Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-CHUS in Sherbrooke, Canada. Data sharing policies are consistent with the governance policy of the HeLTI consortium and government legislation. TRIAL REGISTRATION NUMBER: ChiCTR1800017773. PROTOCOL VERSION: November 11, 2020 (Version #5).

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.

BACKGROUND: Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications. The objective of this trial is to assess whether a multifaceted intervention would reduce the rate of major perinatal morbidity among women with one prior cesarean. METHODS/DESIGN: The study is a stratified, non-blinded, cluster-randomized, parallel-group trial of a multifaceted intervention. Hospitals in Quebec are the units of randomization and women are the units of analysis. As depicted in Figure 1, the study includes a 1-year pre-intervention period (baseline), a 5-month implementation period, and a 2-year intervention period. At the end of the baseline period, 20 hospitals will be allocated to the intervention group and 20 to the control group, using a randomization stratified by level of care. Medical records will be used to collect data before and during the intervention period. Primary outcome is the rate of a composite of major perinatal morbidities measured during the intervention period. Secondary outcomes include major and minor maternal morbidity; minor perinatal morbidity; and TOL and VBAC rate. The effect of the intervention will be assessed using the multivariable generalized-estimating-equations extension of logistic regression. The evaluation will include subgroup analyses for preterm and term birth, and a cost-effectiveness analysis. DISCUSSION: The intervention is designed to facilitate: (1) women's decision-making process, using a decision analysis tool (DAT), (2) an estimate of uterine rupture risk during TOL using ultrasound evaluation of low-uterine segment thickness, (3) an estimate of chance of TOL success, using a validated prediction tool, and (4) the implementation of best practices for intrapartum management. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.

Effectiveness of demand generation interventions on use of modern contraceptives in low- and middle-income countries.

OBJECTIVES: To synthesise evidence on the implementation, costs and cost-effectiveness of demand generation interventions and their effectiveness in improving uptake of modern contraception methods. METHODS: A Cochrane systematic review was conducted. Searches were performed in electronic databases (MEDLINE, EMBASE) and the grey literature. Randomised controlled trials, cluster randomised trials and quasi-experimental studies, including controlled before-after studies (CBAs) and cost and cost-effectiveness studies that aimed to assess demand interventions (including community- and facility-based interventions, financial mechanisms and mass media campaigns) in low- and middle-income countries were considered. Meta-analyses and narrative synthesis were conducted. RESULTS: In total, 20 papers meeting the inclusion criteria were included in this review. Of those, 13 were used for meta-analysis. Few data were available on implementation and on the influence of context on demand interventions. Involving family members during counselling, providing education activities and increasing exposure to those activities could enhance the success of demand interventions. Demand generation interventions were positively associated with increases in current use (pooled OR 1.57; 95% CI: 1.46-1.69, P < 0.01). Financial mechanism interventions (vouchers) appeared effective to increase use of modern contraceptive methods (pooled OR 2.16; 95% CI: 1.91-2.45, P < 0.01; I2 = 0%). Demand interventions improved knowledge (pooled OR 1.02; 95% CI 0.63-1.64, P = 0.93) and attitudes towards family planning and improved discussion with partners/husbands around modern contraceptive methods. However, given the limited number of studies included in each category of demand generation interventions, the dates of publication of the studies and their low quality, caution is advised in considering the results. Very limited evidence was available on costs; studies including data on costs were old and inconsistent. CONCLUSION: Demand generation interventions contribute to increases in modern contraceptive methods use. However, more studies with robust designs are needed to identify the most effective demand generation intervention to increase uptake of modern contraceptive methods. More evidence is also needed about implementation, costs and cost-effectiveness to inform decisions on sustainability and scaling-up.

Maternal and perinatal outcomes associated with a trial of labour after previous caesarean section in sub-Saharan countries.

OBJECTIVE: To assess the risks of uterine rupture, maternal and perinatal outcomes associated with a trial of labour (TOL) after one previous caesarean were compared with having an elective repeated caesarean section (ERCS) without labour in low-resource settings. DESIGN: A prospective 4-year observational study. SETTING: Senegal and Mali. SAMPLE: A cohort of 9712 women with one previous caesarean delivery. METHODS: Maternal and perinatal outcomes were compared between 8083 women who underwent a TOL and 1629 women who had an ERCS. Perinatal and maternal outcomes were then stratified according to the presence or absence of risk factors associated with vaginal birth after caesarean section. These outcomes were adjusted on maternal, perinatal and institutional characteristics. MAIN OUTCOME MEASURES: The risks of uterine rupture, maternal complication and perinatal mortality associated with TOL after one previous caesarean as compared with ERCS, RESULTS: The risks of hospital-based maternal complication [adjusted odds ratio (OR) 1.52; 95% CI 1.09-2.13; P = 0.013] and perinatal mortality (adjusted OR 4.53; 95% CI 2.30-9.92; P < 0.001) were significantly higher in women with a TOL compared with women who had an ERCS. However, when restricted to low-risk women, these differences were not significant (adjusted OR 0.90, 95% CI 0.55-1.46, P = 0.68, and adjusted OR 1.13; 95% CI 0.75-1.86; P = 0.53, for each outcome, respectively). Uterine rupture occurred in 25 (0.64%) of 3885 low-risk women compared with 70 (1.66%) of 4198 women with unfavourable risk factors. CONCLUSION: Low-risk women have no increased risk of maternal complications or perinatal mortality compared with women with one or more unfavourable factors. TWEETABLE ABSTRACT: Low-risk women have a lower risk of maternal complications or perinatal mortality compared with high-risk women.

Timing of Demirjian's tooth formation stages.

BACKGROUND: Global differences in Demirjian et al.'s method of assessing dental maturity are thought to be due to population differences. AIM: The aim of this study was to investigate the timing of individual tooth formation stages in children from eight countries. RESEARCH DESIGN: This was a meta-analysis of previously published data from retrospective cross-sectional studies of dental maturity. METHOD: Data of mandibular permanent developing teeth from panoramic radiographs (Demirjian's stages) were combined from Australia, Belgium, Canada, England, Finland, France, South Korea and Sweden (n = 9002, ages 2-16.99 years). Age-of-attainment was calculated using logistic regression for each group by sex and meta-analysis of the total. Overlapping 95% confidence intervals of the means was interpreted as no significant difference. RESULTS: Mean ages for each group and total were significantly different in 65 out of 509 comparisons (p < 0.05). Some of these were of small sample size but there was no consistent pattern. Apex closure of the first molar was significantly later in children from Quebec and this might explain differences found in the dental maturity score. CONCLUSIONS: These results suggest no major differences in the timing of tooth formation stages between these children. This fails to explain previous findings of differences using Demirjian's dental maturity method.

A new minimally invasive heart surgery instrument for atrial fibrillation treatment: first in vitro and animal tests.

BACKGROUND: The paper presents a new robotic system for beating heart surgery. The final goal of this project is to develop a tele-operated system for the thoracoscopic treatment of patients with atrial fibrillation. The system consists of a robot that moves an innovative end-effector used to perform lines as in the Cox-Maze technique. METHODS: The device is an electrode mesh that is introduced in the thorax through a trocar and is deployed inside the left atrium, where it can create selective ablation lines at any atrial region, using radio frequency. The current version of the umbrella has 22 electrodes. Using visual feedback from an ultrasound based navigation system, the surgeon can choose which electrodes on the mesh to activate. Once the umbrella is in contact with the endocardium of the left atrium, at the expected position, the surgeon activates the chosen electrodes sequentially. The umbrella can then be moved to another position. RESULTS: In vitro and in vivo animal tests have been carried out in order to test and improve the instrument, the robotic system and the operative procedure. CONCLUSIONS: The performed trials proved the ability of the system to treat atrial fibrillation. More in vivo tests are currently being performed to make the robot and its device ready for clinical use.

Dental maturity in Belgian children using Demirjian's method and polynomial functions: new standard curves for forensic and clinical use.

Dental maturity was studied from dental panoramic radiographs of 2523 Belgian children (1255 girls and 1268 boys) aged 2 to 18 years. The aim was to compare the efficiency of two methods of age prediction: Demirjian's method, using differently weighted scores, and polynomial functions. The two methods present some differences: Demirjian is used to determine the maturity score as a function of age and polynomial functions are used to determine age as a function of the maturity score. We present, for each method, gender-specific dental maturity tables and curves for Belgian children. Girls always present advanced dental maturity compared with boys. The polynomial functions are highly reliable (0.21% of incorrect classifications) and the percentile method, using Belgian weighted scores, is very accurate (+/- 2.08 years on average, between 2 and 16 years of age).

[Anatomy of the auditory tube: CT scan and MRI aspect]. / Anatomie de la trompe auditive: aspect tomodensitométrique et IRM.

The auditory tube is a bony and cartilaginous canal which connects the middle ear to the nasopharynx. The bony portion (protympanum), explored by computed tomography, is cone shaped, with a posterior base. The main relations are: the intrapetrous carotid, the tensor tympani muscle, the middle cerebral fossa and temporo-mandibular joint. The fibrocartilaginous portion is explored by computed tomography and mainly by magnetic resonance. The fibrocartilaginous tube is posteromedial; its upper margin is curled outward to form the roof of the cartilaginous tube. Anterioly and Laterally, the auditory tube is closed by a fibrous membrane extending along the inferior surface of the auditory tube to form its floor. The auditory tube is in contact with two main muscle: the tensor veli palatini anterolateral and the levator veli palatini posterolateral and inferior. They are bounded by fascia: the intrapharyngeal fascia is medial, the pharyngo basilar fascia (salpingopharyngeal fascia of Trölstch, is between the tensor and levator veli palatini muscles; the fascia of Weber Liel is lateral to the tensor veli palatini. The auditory tube and its muscles form the lateral wall of the rhinopharynx and prevent the extension of a pathologic process to the para pharyngeal and infratemporal spaces.

Symptomatic bradycardia caused by mianserin at therapeutic doses.

An acute episode of symptomatic sinus bradycardia, occurred in a 50-year-old female patient after she had been given a single therapeutic dose of mianserin. Heart rate was corrected by atropine injection. Re-administration of mianserin resulted in the recurrence of bradycardia. Further examination showed no cardiac abnormalities. This case is the first report of conduction defect in a patient given therapeutic doses of mianserin.