Clinical trial: Longitudinal Study of Vaginal Flora (NCT00340275)

Eligibility criteria:
-  ELIGIBILITY CRITERIA:

          -  Females, age 15-44.

          -  Since bacterial vaginosis is primarily a condition of reproductive-age women, this
             study will be restricted to women regarded by demographers as reproductive age.

          -  Non-pregnant women whose last menstrual period is later than expected will undergo a
             urine pregnancy test. Women who become pregnant while on study will complete their
             next regularly scheduled study visit, following which their participation will
             terminate.

        EXCLUSION CRITERIA:

          1. Immunocompromised status

             Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive
             drugs.

             Receiving or expected to receive in the next 12 months one or more 30-day courses of
             corticosteroids.

             Congenital or acquired immune deficiency; known HIV positivity.

          2. Primary or secondary affective disorder, psychosis, emotional or intellectual
             limitations that preclude informed consent.

          3. Non-fluency in English.

          4. Post-menopausal (natural or surgical).

          5. Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.

          6. Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the
             next 12 months.

          7. Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in
             the next 12 months.

          8. Planning to move out of the area in the next 12 months.

          9. Participating or expected to participate during the next 12 months in a clinical trial
             in which antibiotics or topical microbicides will be administered in a blinded manner.

         10. Women who unexpectedly develop one of these conditions during their participation will
             continue to be followed, unless a specific contraindication arises.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 44 Years

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