Clinical trial: The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy (NCT01287728)

Eligibility criteria:
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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction