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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01287728
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact
Status Completed
Phase Phase 3
Start date January 2011
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT01722708 - Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies N/A