An observational study in Vaginitis, sponsored by Affiliated Hospital of Nantong University. Status unknown at 10 sites in China. Open to female participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by Affiliated Hospital of Nantong University · Observational
The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.
The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 140 across 22 observational studies indexed under Vaginitis.
Browse Vaginitis studies →Affiliated Hospital of Nantong University is the lead sponsor of 97 studies on the registry; 57 are open to participants now.
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Female patients with suspected fungal vaginitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
Exclusion Criteria:
A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi
Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd. Samples are human vaginal secretions. Each sample should be the amount on one swab. The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.
Comparing the positive detection rate of 3/4 different detection methods in the first phase.
The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P\<0.05 was used to determine whether it was statistically significant.
Time frame: From Aug. 1st to Dec. 31st, 2021
Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.
Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).
Time frame: From Aug. 1st, 2021 to Jan. 31st, 2022
Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage.
the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests
Time frame: From Mar. 1, 2022 to Dec. 31st, 2022
Plan to share: No — Not planning sharing at present.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital of Nantong University