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Perinatal challenges for mothers of Haitian origin and their newborns in French Guiana: a historical cohort from 2013 to 2021
No full textInternational audienceObjectives: To describe the sociodemographic characteristics of mothers of Haitian origin and the obstetric and neonatal outcomes of their newborns born in French Guiana between 2013 and 2021 in order to identify specific vulnerabilities within this population.Design: A descriptive, population-based study using data from a comprehensive birth cohort including all deliveries in French Guiana from 2013 to 2021.Setting: All maternity units in French Guiana, a French overseas territory located in South America.Participants: A total of 66 485 live births were recorded during the study period, including 14 065 (21.2%) births to mothers of Haitian origin.Primary and secondary outcome measures: Sociodemographic characteristics, antenatal care indicators and neonatal outcomes were compared between mothers of Haitian origin and mothers of other origins. Adjusted odds ratios (aOR) and 95% CI were calculated for key outcomes.Results: Compared with mothers of other origins, Haitian mothers had higher odds of delivering a newborn small for gestational age (aOR=1.41, 95% CI 1.32 to 1.50), neonatal hospitalisation at birth (aOR=1.19, 95% CI 1.11 to 1.28), having an insufficient number of antenatal visits (aOR=1.32, 95% CI 1.26 to 1.38) and lacking health insurance coverage (aOR=2.83, 95% CI 2.52 to 3.17). Conversely, they had a lower risk of adolescent pregnancy (<20 years; aOR=0.24, 95% CI 0.21 to 0.26). The risk of preterm birth did not differ significantly between groups (p=0.24).Conclusion: Mothers of Haitian origin in French Guiana experience distinct social and perinatal vulnerabilities. Strengthening equitable access to healthcare and implementing targeted community-based interventions are essential to improve maternal and neonatal health outcomes in this population
Accuracy and reliability of an augmented reality prototype for robot-assisted partial nephrectomy: a preclinical study with 3D-printed kidney phantoms (UroCCR 168)
No full textInternational audienceIntroduction. Augmented Reality (AR) systems can enhance intraoperative anatomical understanding during Robot-Assisted Partial Nephrectomy by overlaying preoperative 3D models onto the surgical view. Their usefulness, however, depends on the spatial accuracy of these overlays, which requires objective validation.Methods. This preclinical study quantitatively evaluated the spatial accuracy of a new AR software prototype using a validation workflow based on 3D-printed kidney phantoms and a Structure-from-Motion (SfM) reconstruction as ground truth. CT scans were segmented to create virtual kidney models that were 3D printed and filmed with the da Vinci Si camera. The AR prototype was applied to the recordings, and manual 3D registration was performed using the TilePro interface. Keyframes from manual and tracking-based registrations were analysed to compute the Target Registration Error (TRE), defined as the mean Euclidean distance between corresponding vertices of the AR and SfM models. Three operators repeated the workflow, and manual registration time was recorded to assess variability and feasibility.Results. Mean TRE across experiments was below 5 mm, indicating clinically acceptable accuracy. TRE values for individual keyframes remained consistently under 10 mm, with limited inter-operator variability (ICC(3,k) = 0.80). Manual and tracking TREs were comparable and strongly correlated (β = 0.89; p < 0.001). Tracking-related precision changes varied among operators, and mean manual registration time was 173.6 ± 76.4 s. Accuracy was unaffected by keyframe count, kidney variability, or registration duration.Conclusion. This methodology offers an objective, reproducible framework for assessing AR registration in preclinical settings. The prototype showed reliable spatial performance, supporting progression toward in vivo validation
Solid-State Stability of Pentobarbital in Fast-Dissolving Suppositories: Implications for Dissolution Behavior and Pediatric Formulation Performance
No full textInternational audienceBackgroundSafe and well-tolerated sedative formulations are essential in pediatric procedural care. Pentobarbital, a short-acting barbiturate, remains widely used for pediatric sedation. However, its oral administration is limited by poor palatability. Rectal administration therefore represents a relevant alternative, provided that formulation stability is ensured. This study evaluated the physicochemical and microbiological stability of fast-dissolving pentobarbital suppositories developed for pediatric use.MethodsSuppositories containing 30 or 60 mg of pentobarbital sodium were formulated with two sodium hydroxide (NaOH) concentrations and stored under refrigerated (5 degrees C) or frozen (-20 degrees C) conditions for up to 180 days. Stability was assessed by macroscopic examination, pH measurement, dissolution testing, mechanical strength, softening time, and microbiological quality. Solid-state changes were analyzed using Raman spectroscopy and X-ray diffraction, and precipitation kinetics were modeled.ResultsRefrigerated storage led to progressive precipitation from day 90, associated with pH decrease and conversion of pentobarbital sodium to its free acid, resulting in incomplete dissolution. In contrast, frozen storage preserved pH, physical integrity, and complete dissolution, even after 30 days at 5 degrees C following thawing. Spectroscopic and diffraction analyses confirmed recrystallization under refrigeration, whereas frozen formulations retained an amorphous structure. Increased NaOH content delayed, but did not prevent, instability at 5 degrees C. All formulations complied with pharmacopeial mechanical and microbiological requirements.ConclusionStorage temperature was the main determinant of stability, with freezing ensuring long-term preservation. NaOH buffering mitigated gelatin acidity and delayed drug conversion, thereby extending shelf life. These findings support further biopharmaceutical and clinical evaluation of pentobarbital suppositories for pediatric sedation
Long-term outcomes and temporal trends following liver transplantation for chronic liver disease in intensive care unit.
No full textInternational audienceBackground and Aims: Liver transplantation (LT) remains the definitive treatment for patients with end-stage chronic liver disease (CLD). However, those transplanted while in intensive care unit (ICU) represent a high-risk population. Large-scale data on long-term prognosis in this group are limited. We aimed to assess long-term outcomes in CLD patients undergoing LT from the ICU and to compare outcomes over time.Methods: This retrospective cohort study used the French national transplant registry (CRISTAL). Adults with CLD who underwent LT from the ICU between 2008 and 2018 were included. Organ failures were defined according to EASL CLIF-OF criteria. Five-year survival and associated risk factors were analyzed and compared across four time periods (2008–2010, 2011–2013, 2014–2016, 2017–2018).Results: Among 13,372 LTs performed in France during the study period, 9,686 were for CLD, of whom 1,287 (13.2%) were in the ICU at the time of LT. Alcohol-related liver disease (50%) and viral hepatitis (16.1%) were the leading etiologies. Five-year survival was significantly lower in CLD-ICU patients compared to non-ICU patients (69.2% vs. 79.1%, p<0.0001). Among 1-year survivors, 5-year survival exceeded 83% and was not different to that of CLD patients transplanted outside ICU. Survival by era showed no significant improvement (p=0.28). Age (HR 1.03, p<0.0001), mechanical ventilation (HR 1.57, p=0.0001) and French Donor Risk Score (HR 1.05, 95%CI [1.02-1.09], p<0.001) were independent predictors of mortality.ConclusionPatients transplanted from the ICU have significantly lower long-term survival, primarily due to elevated early post-transplant mortality, with no observed improvement over time. Careful candidate evaluation and donor selection remain critical to improving outcomes in this high-risk population.Impact and Implications: This large national cohort study provides a comprehensive evaluation of long-term outcomes in critically ill cirrhotic patients undergoing liver transplantation while in the ICU. Despite advances in transplant care over the past decade, we observed a persistent survival gap in this high-risk population, primarily driven by increased mortality within the first year after transplantation. Age, the need for mechanical ventilation, and donor-related factors were independently associated with this excess risk. We also found no significant improvement in outcomes over time. These results underscore the continued need for refined candidate selection and donor allocation strategies, taking into account age, pre-transplant clinical stability, and graft quality to optimize post-transplant survival.Trial Registration: ClinicalTrials.gov number NCT0663640
Prise en charge thérapeutique des grossesses extra-utérines tubaires. Recommandations pour la pratique clinique du CNGOF et de la SCGP
No full textInternational audience• Ectopic Pregnancy is defined as the presence of a pregnancy or pregnancy residue outside the uterine cavity, with a prevalence of approximately 2%. Tubal ectopic pregnancy is defined as the presence of a pregnancy or pregnancy residue in the extra-myometrial portion of the fallopian tube (isthmus, ampulla, or fimbriae), and accounts for 96 to 99% of ectopic pregnancy locations. Management of tubal ectopic pregnancy should depend on both its activity and whether it is symptomatic or not. • Regarding emergency management of tubal ectopic pregnancy, it is recommended not to consider expectant management for patients with symptomatic tubal ectopic pregnancy, nor for patients with active tubal ectopic pregnancy (Strong recommendation, low quality of evidence). It is recommended to offer expectant management as an alternative to medical treatment with MTX (methotrexate) for patients with non-active and asymptomatic tubal ectopic pregnancy (Strong recommendation, low quality of evidence). It is recommended to offer expectant management as an alternative to surgical treatment for patients with non-active and asymptomatic tubal ectopic pregnancy (Strong recommendation, very low quality of evidence). In cases of expectant management of tubal ectopic pregnancy, it is strongly recommended to systematically re-evaluate the patient clinically and biologically at 48 hours (Strong recommendation, low quality of evidence). If hCG levels decrease by more than 15% at 48 hours, it is recommended to continue monitoring weekly until negativity, provided there are no signs of symptomatic tubal ectopic pregnancy (Strong recommendation, very low quality of evidence). If an expectant approach is chosen, and there is an increase in hCG levels of more than 15% at 48 hours or the tubal ectopic pregnancy becomes symptomatic, it is recommended to discontinue expectant management (Strong recommendation, low quality of evidence). • Regarding medical treatment of tubal ectopic pregnancy, it is recommended not to favor a multi-dose protocol over a single-dose protocol to increase the success rate of MTX treatment (Strong recommendation, moderate quality of evidence). It is recommended to prefer the single-dose MTX protocol over the multi-dose protocol to limit the risk of adverse effects (Strong recommendation, high quality of evidence). It is also recommended not to systematically combine mifepristone treatment with an MTX injection to improve the efficacy of medical treatment for tubal ectopic pregnancy (Strong recommendation, high quality of evidence). • Regarding surgical management, in a patient with tubal ectopic pregnancy, it is recommended to perform either salpingotomy or salpingectomy with regard to fertility (Strong recommendation, high quality of evidence). It is recommended not to perform tubal expression in order to reduce morbidity compared to salpingotomy (Strong recommendation, very low quality of evidence).La Grossesse Extra-Utérine (GEU) est définie par la présence d’une grossesse ou d’un résidu de grossesse en dehors de la cavité utérine sa prévalence est d’environ 2%. La GEU tubaire est définie comme la présence d’une grossesse ou d’un résidu de grossesse dans la portion extra-myométriale de la trompe (isthme, ampoule ou pavillon) et représente 96 à 99% des localisations de GEU. La prise en charge de la GEU tubaire doit dépendre à la fois de son activité et de son caractère symptomatique ou non. Concernant la prise en charge en urgence d’une GEU tubaire, Il est recommandé de ne pas envisager une attitude expectative pour des patientes présentant une GEU tubaire symptomatique, ni pour pour des patientes présentant une GEU tubaire active (Recommandation forte, qualité de la preuve basse). Il est recommandé de proposer une attitude expectative comme alternative au traitement médical par méthotrexate (MTX) aux patientes présentant une GEU tubaire non active et asymptomatique (Recommandation forte, qualité de la preuve basse). Il est recommandé de proposer une attitude expectative comme alternative au traitement chirurgical aux patientes présentant une GEU tubaire non active et asymptomatique ( Recommandation forte, qualité de la preuve très basse). Il est recommandé, en cas de prise en charge d’une GEU tubaire par expectative, de réévaluer systématiquement cliniquement et biologiquement la patiente à 48 heures (Recommandation forte, qualité de la preuve basse) et en cas de décroissance des HCG >15% à 48h, il est recommandé de poursuivre la surveillance de la décroissance une fois par semaine jusqu’à négativation en l’absence de signes de GEU tubaire symptomatique (Recommandation forte, qualité de la preuve très basse), Si une attitude d’expectative est retenue, en cas d’augmentation des HCG > 15% à 48h ou en cas de GEU tubaire devenant symptomatique, il est recommandé de ne pas poursuivre l’attitude expectative (Recommandation forte, qualité de la preuve basse). Concernant les modalités du traitement médical de la GEU tubaire, Il est recommandé de ne pas privilégier un protocole multidose par rapport à un protocole monodose afin d’augmenter le taux de succès d’un traitement par MTX. (Recommandation forte, qualité de la preuve modérée). Il est recommandé de privilégier le traitement monodose de MTX au protocole multidose afin de limiter le risque d’effets indésirables (Recommandation forte, qualité de la preuve élévée). . il est recommandé de ne pas associer systématiquement un traitement par mifépristone à une injection de MTX pour augmenter l’efficacité du traitement médical d’une GEU tubaire (Recommandation forte, qualité de la preuve élevée). Concernant la prise en charge chirurgicale, chez une patiente présentant une GEU tubaire, il est recommandé de réaliser soit une salpingotomie soit une salpingectomie pour la fertilité. (Recommandation forte, qualité de la preuve élévée). Il est recommandé de ne pas pratiquer une expression tubaire pour diminuer la morbidité par rapport à la salpingotomie (Recommandation forte, qualité de la preuve très basse)
Professional practice guidelines: Eco-Responsible Optimization of Choice and use of Drugs and Medical Devices in operating theaters or interventional sector
No full textInternational audienceObjectif: To provide recommendations for eco-responsible optimization of choice and use of medicines and medical devices.Design: A committee of 16 experts brought together by CERES and from SPFDM/Euro-Pharmat, SFAR, SFCR, SFED, SF2H, SFPC, SFR, SF2S has been set up. A policy for declaring links of interest was applied and respected throughout the process of creating the reference system. Similarly, it has not provided any funding from a company marketing a health product (drug or medical device). The committee had to respect and follow the GRADE® method (Grading of Recommendations Assessment, Development and Evaluation) to assess the quality of the evidence on which the recommendations were based.Methods: The recommendations were formulated by identifying 4 different fields: practice of care (optimization of medicines and medical devices), packaging (reduction of the environmental impact of medical devices), organization of care (integration of environmental criteria) and waste management (reduction, sorting and recovery). Each question was formulated according to the PICO (Patients, Intervention, Comparison, Outcome) format. The analysis of the literature and the recommendations were carried out according to the GRADE® methodology.Results: The experts' synthesis work resulted in 46 recommendations validated after one round of voting. For all questions, since the GRADE grid ® method could not be applied in full, the recommendations were formulated in the form of expert opinions.Conclusion: From a strong agreement between experts, we were able to formulate 46 recommendations for eco-responsible optimization of the choice and use of medicines and medical devices
A contemporary picture of bacterial infections in patients with hereditary hemorrhagic telangiectasia: A nationwide cohort study
No full textInternational audienceObjectives: Patients with hereditary hemorrhagic telangiectasia (HHT) present increased risk of severe infections. Studies focusing on infections in HHT population are scarce. We aimed to assess characteristics and outcomes of infections in patients with HHT.Methods: A retrospective study was conducted in a nationwide cohort of 4502 HHT patients. Patients with HHT hospitalized for infection across 16 referral centers in France between 2010 and 2024 were identified, and data were collected through a standardized questionnaire.Results: We included 163 HHT patients (median age, 60 years [49-69], 52% male), who experienced a total of 249 bacterial infections. One third (n=53/163) experienced recurrent infections requiring hospitalization. Infections caused by Staphylococcus aureus were reported in 80 patients representing 107 episodes of infection. Brain abscesses were reported in 43 patients representing 51 episodes, often despite prior pulmonary arteriovenous malformations embolization (n=17/43). In multivariable analysis, factors associated with 1-year mortality (n=27/163, 17%) were age (aHR=1.06, 95%CI:1.01-1.16) and infective endocarditis (aHR=2.88, 95%CI:1.10-7.87).Conclusions: In this HHT cohort, severe infections were predominantly due to S. aureus, far ahead of brain abscesses caused by oral bacteria. Considering the high rate of recurrent infections, further studies focusing on prophylaxis strategies in HHT patients are needed
Association between physical activity with disease activity and functional disability in patients with inflammatory bowel disease
No full textInternational audienceBackground and aims: The impact of Physical activity (PA) on the activity of inflammatory bowel disease (IBD) remains unclear.Patients and methods: A descriptive cross-sectional study included consecutive patients with Crohn's disease (CD), ulcerative colitis (UC). PA was assessed using the short International Physical Activity Questionnaire. PA was classified as low, medium or high PA. PA was also assessed according to WHO recommendations. IBD activity was evaluated using PRO-2, while IBD-related disability was assessed with the IBD-disk questionnaire.Results: Among a total of 2514 patients (1715 CD), only 28.8% met the WHO recommendations on PA (49.8% had low PA, 35.2% had medium PA, and 15.0% had high PA). Medium and high PA levels were associated with a higher rate of patient-reported clinical remission in patients with CD (OR 1.30 [1.08-1.57] for medium PA, and 1.33 [1.03-1.72] for high PA vs. low PA; p-trend=0.02) but not in those with UC. Higher PA levels were associated with less IBD-related disability in both CD, and UC.Conclusion: In a large cohort of IBD patients, moderate and high PA was associated with higher rates of clinical remission in patients with CD and lower IBD-related disability in both CD and UC patients
Clinical Manifestations of Emerging Trichosporon spp. Infections, France
No full textInternational audienceFungi in the family Trichosporonaceae are rarely involved in invasive disease but are frequently associated with colonization or respiratory allergic infection. Trichosporonaceae exhibit intrinsic resistance to echinocandin antimicrobial drugs, posing challenges for treatment and contributing to high mortality rates. We complied a nationwide analysis of 112 cases of invasive disease caused by Trichosporon spp. and related fungi, diagnosed in France over 20 years, that combined clinical data, susceptibility profiles, and molecular identification. We identified 12 species; T. asahii was the most common species recovered, and the new species T. austroamericanum was next. Comparison of clinical data highlighted species and genotypic differences, such as a much higher proportion of children infected by T. asahii and major differences in antimicrobial drug susceptibility. Correct identification is not only of epidemiologic interest but also necessary for patient management because of the varying clinical and microbiological characteristics found in different species
Psychoactive substances in a general forensic autopsy population: prevalence and associations with cause and manner of death
No full textInternational audienceThis study investigated the prevalence of opioid-related deaths within a general forensic population. Conducted as a prospective, single-center, observational study, it included all subjects autopsied in forensic medicine in the Auvergne region (France). The primary objective was to assess the prevalence of opioid-related deaths in forensic cases, with secondary objectives including evaluating the prevalence of non-opioid psychoactive substances, screening blood alcohol levels, and profiling victims.Among 422 subjects who died from unnatural causes, the leading causes of death were suicide (51.7%) and accidents (39.8%). Opioids were detected in 24.2% of individuals, but directly involved in only 17.6% of those cases. Substances, including alcohol, were found in more than two-thirds of deaths (71.2%). Three distinct victim profiles were identified: middle-aged and elderly males dying by violent suicide; young males dying by fatal traffic accidents, often under the influence of alcohol and drugs of abuse; and young males dying by homicides, frequently under the influence of alcohol, opioids and toxic or lethal drugs.The study provides data on the prevalence and role of opioids, alcohol, and non-opioid psychoactive substances in forensic deaths. While opioids were directly implicated in a limited number of cases, the study highlights the significant presence of alcohol and other non-opioid psychoactive substances in unnatural deaths. These findings, suggest that further research with a larger study area and more cases would be beneficial