Abnormal Vaginal Flora
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGTreatment BY METROMIDAZOLE
Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman of more than 18 years, presenting vulvo-vaginal symptoms to type(chap) of smell or abnormal vaginal losses the day of the inclusion and having an imbalance of the vaginal flora objectivized by: * The presence of at least 3 clinical criteria of Amsel ( 41 ) is a score of Nugent \> 4 ( 42 ) * Woman in genital encircled period of activity (negative pregnancy test in the inclusion) and under effective contraception, including an intra-uterine device (mechanical, hormonal). * Woman ménopausée with or without hormonal treatment (by way oral, transcutaneous, sous cutaneous, vaginal). * Woman encircled at the time of the inclusion. * Having Woman was treated(handled) for a vaginal infection or one imbalance of the vaginal flora more than 7 days ago. * Woman having understood(included) the progress and the objectives of the study and having agreed to sign a lit(enlightened) consent. * Only the profitable women of a national insurance scheme will be included
Exclusion criteria
* Woman presenting a sexually transmitted infection (infection with gonococcus, with Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results(profits) of which will be known only secondarily. * Pregnant Woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy. * Woman removing her consent during the study. * Lost sight Woman. * Woman deprived of freedom, judicial or administrative; * Woman hospitalized for quite other reason that looks for her(it); * Woman hospitalized in a sanitary establishment or social in the other purposes that the research; * Major Woman except state to express its consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To access the value of A. vaginae and G. vaginalis loads in predicting recurrence of abnormal vaginal flora over the course of 12 months after oral metronidazole therapy. | 2 YEARS |
Secondary
| Measure | Time frame |
|---|---|
| Inform the predictive and technical characteristics (sensibility and specificity) vaginal microbial concentrations | 2 YEARS |
Countries
France
Outcome results
None listed