NCT02203942

Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Bacterial Vaginosis
• Vulvovaginal Candidiasis
• Trichomoniasis

Interventions

Type	Name	Description
OTHER	NAAT testing	comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-07-30
• Last updated: 2016-01-27

Locations

1 site across 1 country: United States