NCT02288832: AuTop

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

Completed Phase 2, PHASE3 Last updated 13 April 2023

What this trial tests

Phase 2, PHASE3 trial testing -self-collected vaginal samples in Low Risk of Preterm Delivery in 6,800 participants. Completed in 21 October 2022.

Timeline

6 March 2015

Primary endpoint
1 July 2018

21 October 2022

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	6,800
Start date	6 March 2015
Primary completion	1 July 2018
Estimated completion	21 October 2022
Sites	2 locations across France

Drugs / interventions tested

• -self-collected vaginal samples
• zithromax (azithromycin) — full drug profile →
• usual practices — full drug profile →

Conditions studied

• Low Risk of Preterm Delivery — all drugs for Low Risk of Preterm Delivery →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, female only, with Low Risk of Preterm Delivery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial.
   Bretelle F, Loubière S, Desbriere R, Loundou A, et al · · 2023 · cited 15× · PMID 37459059 · DOI 10.1001/jamapediatrics.2023.2250
2. 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.
   Bretelle F, Fenollar F, Baumstarck K, Fortanier C, et al · · 2015 · cited 9× · PMID 26482128 · DOI 10.1186/s13063-015-1000-y
3. Cost-effectiveness of a real-time screening strategy for bacterial vaginosis using qPCR to prevent preterm birth: results from a randomized prospective multicenter study.
   Loubiere S, Loundou A, Cocallemen JF, Fenollar F, et al · · 2026 · PMID 42252439 · DOI 10.1186/s12962-026-00780-7