Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Women's Studies, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | June 2015 |
Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.
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).
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.
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.
Inclusion Criteria:
1. Female participants aged 18 and older
2. Based on symptoms:
- Symptomatic patients: with symptoms of vaginitis that include abnormal
discharge, malodor, itching, irritation and / or discomfort
- Asymptomatic controls: no vulvovaginal symptoms
3. Willing to provide written informed consent for participation in this study
Exclusion Criteria:
1. Use of oral antibiotics in the past 14 days
2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24
hour
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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