Florence Bretelle1, Patrick Rozenberg2, Alain Pascal3, Romain Favre4, Caroline Bohec5, Anderson Loundou6, Marie-Victoire Senat7, Germain Aissi4, Nathalie Lesavre8, Julie Brunet8, Hélène Heckenroth9, Dominique Luton10, Didier Raoult11, Florence Fenollar11. 1. Department of Gynecology and Obstetrics, Gynépole, Marseille, Pr Boubli et D'Ercole, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, AMU, Aix-Marseille Université Aix-Marseille Université, Unité de Recherche sur les Maladies Infectieuses Tropicales et Emergentes, UM63, CNRS 7278, IRD 198, INSERM 1095, Marseille. 2. Department d'obstétrique et gynécologie, Centre Hospitalier Poissy Saint-Germain en Laye. 3. Service de Gynecologie Obstétrique Hôpital Fondation Saint Joseph Marseille. 4. Service de Gynecologie Obstétrique du CMCO-HUS, Schiltigheim/Strasbourg. 5. Service de Gynécologie-Obstétrique, CIC, CHU Brest, Hôpital Morvan, CH de Pau. 6. Medical Evaluation, Department of Public Health, Assistance Publique-Hôpitaux de Marseille, AMU, Aix-Marseille Université 7. Hôpital Antoine Béclère et Kremlin-Bicêtre, Department de Gynécologie-Obstétrique, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Université Paris Sud, Faculté de Medecine, Orsay. 8. Centre d'investigation Clinique, Aix-Marseille Université, AP-HM, AMU, Marseille. 9. Department of Gynecology and Obstetrics, Gynépole, Marseille, Pr Boubli et D'Ercole, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, AMU, Aix-Marseille Université 10. Hôpitaux Paris Sud, Hôpital Beaujon, Department of Obstetrics and Gynecology, Hôpital Bichat Beaujon, AP-HP, Université Paris VII Denis Diderot, France. 11. Aix-Marseille Université, Unité de Recherche sur les Maladies Infectieuses Tropicales et Emergentes, UM63, CNRS 7278, IRD 198, INSERM 1095, Marseille.
Abstract
BACKGROUND: Bacterial vaginosis is a risk factor for preterm birth. The various conventional methods for its diagnosis are laborious and not easily reproducible. Molecular quantification methods have been reported recently, but the specific risk factors they might identify remain unclear. METHODS: A prospective multicenter national study included pregnant women at risk of preterm birth. A quantitative molecular tool using a specific real-time polymerase chain reaction assay and serial dilutions of a plasmid suspension quantified Atopobium vaginae, Gardnerella vaginalis, lactobacilli, Mycoplasma hominis, and the human albumin gene (for quality control). RESULTS: In 813 pregnancies, high vaginal loads of either or both of A. vaginae and G. vaginalis were associated with preterm birth (hazard ratio [HR], 3.9; 95% confidence interval {CI}, 1.1-14.1; P = .031). A high vaginal load of A. vaginae was significantly associated with shortened time to delivery and therefore pregnancy length. These times were, respectively, 152.2 and 188.2 days (HR, 5.6; 95% CI, 1.5-21.3; P < .001) before 22 weeks, 149.0 and 183.2 days (HR, 2.8; 95% CI, 1.1-8.2; P = .048) before 28 weeks, and 132.6 and 170.4 days (HR, 2.2; 95% CI, 1.1-4.6; P = .033) before 32 weeks. After multivariate analysis, A. vaginae levels ≥10(8) copies/mL remained significantly associated with delivery before 22 weeks of gestation (adjusted HR, 4.7; 95% CI, .2-17.6; P = .014). CONCLUSIONS: High vaginal loads of A. vaginae and G. vaginalis are associated with late miscarriage and prematurity in high-risk pregnancies. A high vaginal load of A. vaginae (DNA level ≥10(8) copies/mL) identifies a population at high risk of preterm birth. Further studies that both screen for and then treat A. vaginae are needed. CLINICAL TRIALS REGISTRATION: NCT00484653.
BACKGROUND: Bacterial vaginosis is a risk factor for preterm birth. The various conventional methods for its diagnosis are laborious and not easily reproducible. Molecular quantification methods have been reported recently, but the specific risk factors they might identify remain unclear. METHODS: A prospective multicenter national study included pregnant women at risk of preterm birth. A quantitative molecular tool using a specific real-time polymerase chain reaction assay and serial dilutions of a plasmid suspension quantified Atopobium vaginae, Gardnerella vaginalis, lactobacilli, Mycoplasma hominis, and the humanalbumin gene (for quality control). RESULTS: In 813 pregnancies, high vaginal loads of either or both of A. vaginae and G. vaginalis were associated with preterm birth (hazard ratio [HR], 3.9; 95% confidence interval {CI}, 1.1-14.1; P = .031). A high vaginal load of A. vaginae was significantly associated with shortened time to delivery and therefore pregnancy length. These times were, respectively, 152.2 and 188.2 days (HR, 5.6; 95% CI, 1.5-21.3; P < .001) before 22 weeks, 149.0 and 183.2 days (HR, 2.8; 95% CI, 1.1-8.2; P = .048) before 28 weeks, and 132.6 and 170.4 days (HR, 2.2; 95% CI, 1.1-4.6; P = .033) before 32 weeks. After multivariate analysis, A. vaginae levels ≥10(8) copies/mL remained significantly associated with delivery before 22 weeks of gestation (adjusted HR, 4.7; 95% CI, .2-17.6; P = .014). CONCLUSIONS: High vaginal loads of A. vaginae and G. vaginalis are associated with late miscarriage and prematurity in high-risk pregnancies. A high vaginal load of A. vaginae (DNA level ≥10(8) copies/mL) identifies a population at high risk of preterm birth. Further studies that both screen for and then treat A. vaginae are needed. CLINICAL TRIALS REGISTRATION: NCT00484653.
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