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Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial

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  • معلومة اضافية
    • Contributors:
      Assistance Publique - Hôpitaux de Marseille (APHM); Microbes évolution phylogénie et infections (MEPHI); Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS); Hôpital de la Conception CHU - APHM (LA CONCEPTION); Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS); Aix Marseille Université (AMU); Hôpital Saint-Joseph Marseille; Hôpital Nord CHU - APHM; Université Paris Cité (UPCité); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Université Paris-Saclay; Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre; Centre de recherche en épidémiologie et santé des populations (CESP); Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay; Biologie Intégrative du Tissu Osseux (LBTO); Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM); Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE); Centre Ingénierie et Santé (CIS-ENSMSE); École des Mines de Saint-Étienne (Mines Saint-Étienne MSE); Institut Mines-Télécom Paris (IMT)-Institut Mines-Télécom Paris (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE); Institut Mines-Télécom Paris (IMT)-Institut Mines-Télécom Paris (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Centre for Research in Epidemiology and Statistics; Conservatoire National des Arts et Métiers CNAM (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE); Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC); Université Pierre et Marie Curie - Paris 6 (UPMC); Hôpital Trousseau; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Hôpital Archet 2 Nice (CHU); Hôpital Américain de Paris; Biologie de la Reproduction, Environnement, Epigénétique & Développement (BREED); École nationale vétérinaire d'Alfort (ENVA)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE); CHI Poissy - Saint-Germain-en-Laye; Hôpital de la Timone CHU - APHM (TIMONE); Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille); Vecteurs - Infections tropicales et méditerranéennes (VITROME); Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge (IRBA); DIR CENTRALE DU SSA; the AuTop grant was obtained in 2014 through a national research program from Directorate of Health Care Supply under No. PRME 2013–RCAPHM14-0085.; Conflict of Interest Disclosures: Dr Bretelle reported grant PRME 2013–RCAPHM14-0085 from Directorate of Health Care Supply during the conduct of the study. Dr Loubière reported grants from Directorate of Health Care Supply to Assistance Publique–Hôpitaux de Marseille during the conduct of the study. Dr Blanc reported fees for consulting from Organon. Dr Schmitz reported personal fees from Dilafor outside the submitted work. Dr Ménard reported grant PRME 2013–RCAPHM14-0085 from Directorate of Health Care Supply during the conduct of the study and has a patent for European Patent Office No. 2087134 licensed to Université de la Méditerranée (Aix Marseille II). No other disclosures were reported
    • بيانات النشر:
      HAL CCSD
      Lippincott, Williams & Wilkins
    • الموضوع:
      2024
    • نبذة مختصرة :
      International audience ; One of the risk factors for preterm birth (PTB) is bacterial vaginosis (BV), a common, often asymptomatic, vaginal dysbiosis. The earlier BV is diagnosed based on gestational age, the higher the risk of PTB. The effectiveness of a screen-and-treat strategy for BV during pregnancy remains a source of debate. One meta-analyses, including 5 studies and 2346 patients, showed a benefit to screen and treat using clindamycin. Another, with 21 studies and 7847 patients, did not recommend BV screening but observed reductions in preterm delivery by 50% and miscarriages by 80%. In another systematic review, with 48 studies, there was varying accuracy across conventional screening tests for BV and suggested no or inconclusive efficacy in the treatment of asymptomatic BV in the general obstetric population and in those with a history of preterm delivery. Based on these studies, French and international organizations recommend against screening for BV with conventional diagnosis tools in low-risk populations. However, molecular diagnostic tools have been shown to be more accurate in identifying vaginal microbiota than conventional tools, such as clinical diagnosis based on Amsel or Nugent criteria. Molecular tools have been shown to provide an objective, reproducible, quantitative diagnosis of BV, identifying emergent pathogen species, such as Atopobium vaginae (now known as Fannyhessea vaginae). To date, no randomized studies have been conducted to assess the impact of molecular tools on a screen-and-treat intervention to BV. The aim of this study was to assess whether a screen-and-treat intervention using a molecular diagnostic tool is cost-effective in reducing the rate of PTB. The AuTop Trial was a prospective, open-label superiority trial conducted in 19 French maternity hospitals from March 9, 2015, to December 18, 2017. Included were adult women in early pregnancy (<20 weeks of gestation), with no history of PTB or late abortion and no major risk factors for prematurity. Excluded were ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/37459059; hal-04615299; https://hal.science/hal-04615299; https://hal.science/hal-04615299/document; https://hal.science/hal-04615299/file/jamapediatrics_bretelle_2023_oi_230037_1692993154.64609.pdf; PUBMED: 37459059; WOS: 001186671700003
    • الرقم المعرف:
      10.1097/01.ogx.0001010432.99677.5a
    • Rights:
      http://hal.archives-ouvertes.fr/licences/copyright/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.E0D5FFA6