The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora … (NCT01287728) | Clinical Trial Compass
CompletedPhase 3
The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy
France182 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 duri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.