Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
NCT Number: NCT01287728
Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the risk of recurrence.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 3
Marseille, 13354, France
Women with symptomatic abnormal vaginal flora (a Nugent score of 4-10 or sup or egal 3 Amsel criteria) will be enrolled. Abnormal vaginal flora will be treated with 2g of oral metronidazole. Follow-up will be performed at 1 week,1 month and 12 months after treatment. Vaginal samples will be tested by quantitative real time PCR to determine the vaginal concentrations of A. vaginae, G. vaginalis, and Lactobacillus spp.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole
Time frame: 2 YEARS
Time frame: 2 YEARS
Assistance Publique Hopitaux De Marseille
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01722708
Abnormal Vaginal Flora, Bacterial Infections
Tiberias, Israel
View Trial Details