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Validity of Patient-Collected Wet Mounts

NCT02641717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2016-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Vaginal Discharge
  • Trichomonas
  • Candidiasis
  • Vaginosis, Bacterial
  • Vaginitis

Interventions

OTHER

vaginal swab

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Junda Woo, MD, MPH · San Antonio Metropolitan Health District

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641717 on ClinicalTrials.gov