Validity of Patient-Collected Wet Mounts

Completed · Not applicable

Conditions studied: Vaginal Discharge, Trichomonas, Candidiasis, Vaginosis, Bacterial, Vaginitis

In brief

Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic. Research Design/Plan: Prospective, non-randomized, non-blinded trial Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal discharge, odor and/or itching). Calculate concordance between clinician- and patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount, using the clinician-collected specimens as the "gold standard." Clinical Relevance: A "wet mount," or microscopic examination, is commonly used to diagnose trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little information about patient-collected wet mounts exists in the literature. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. The method is highly acceptable to women. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome.

Key facts

Study ID
NCT02641717
Run by
The University of Texas Health Science Center at San Antonio
People needed
77
Starts
2015-11-01
Expected to finish
2016-08-01
Last updated by the study team
2016-08-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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