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Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard.
The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).
Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only in an STD clinic population. The primary outcome of this study is to compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in symptomatic and asymptomatic women in the general gynecology office as well as in a vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to correct treatment for women suffering from vaginitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Infections (BV, VVC, trich) | NAAT testing Amsel criteria Nugent score yeast culture TV culture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAAT testing | Other | comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Vaginal Infections | Compare the sensitivity and specificity of NAAT tests to Amsel criteria, Nugent score for bacterial vaginosis, yeast culture and TV culture in detecting BV, VVC, and trichomoniasis. | approximately 7 days |
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Inclusion Criteria:
Female participants aged 18 and older
Based on symptoms:
Willing to provide written informed consent for participation in this study
Exclusion Criteria:
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Enrollments will include patients seeking care at Magee-Womens Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Harold C Wiesenfeld, MD, CM | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002181 | Candidiasis, Vulvovaginal |
| D014245 | Trichomonas Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |