Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy

Summary

Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries have no abnormal history. It is widely agreed that preterm delivery is often associated with bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the Nugent score, but it lacks the characteristics necessary for widespread use in the general population. It must be performed on a fresh swab, and any delay in transporting it can cause drying that makes the test difficult to perform. The investigators have developed a rapid diagnostic tool for bacterial vaginosis using molecular biology based on a point of care model and obtained a patent (European Patent Office N° 2087134). In comparison with the reference techniques, our tool's performance has been excellent, in terms of specificity, sensitivity, and positive and negative predictive values. In particular, our work showed that 57% of the flora samples rated as intermediate on the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore identifies a homogeneous population of women with vaginal flora anomalies. The investigators recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis \>105/mL shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006). Vaginal flora anomalies are therefore an important target for preventing preterm delivery.

Timeline

Start

2015-03-06

Primary completion

2018-07-01

Completion

2022-10-21

Publications

• Loubiere S, Loundou A, Cocallemen JF, Fenollar F, Bretelle F. Cost-effectiveness of a real-time screening strategy for bacterial vaginosis using qPCR to prevent preterm birth: results from a randomized prospective multicenter study. Cost Eff Resour Alloc. 2026 Jun 8. doi: 10.1186/s12962-026-00780-7. Online ahead of print.
• Bretelle F, Loubiere S, Desbriere R, Loundou A, Blanc J, Heckenroth H, Schmitz T, Benachi A, Haddad B, Mauviel F, Danoy X, Mares P, Chenni N, Menard JP, Cocallemen JF, Slim N, Senat MV, Chauleur C, Bohec C, Kayem G, Trastour C, Bongain A, Rozenberg P, Serazin V, Fenollar F; Groupe de Recherche en Obstetrique et Gynecologie (GROG) Investigators. Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial. JAMA Pediatr. 2023 Sep 1;177(9):894-902. doi: 10.1001/jamapediatrics.2023.2250.
• Bretelle F, Fenollar F, Baumstarck K, Fortanier C, Cocallemen JF, Serazin V, Raoult D, Auquier P, Loubiere S. Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial. Trials. 2015 Oct 19;16:470. doi: 10.1186/s13063-015-1000-y.

Drugs

Indications

No indication recorded.