Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| life-style counseling | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence morphological detection of liquid-based thin-layer film-making fungi | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 (+). | 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 | From Mar. 1, 2022 to Dec. 31st, 2022 |
Not provided
Not provided
Inclusion Criteria:
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:
Fungal vaginitis is a disease that only women get.
Female patients with suspected fungal vaginitis.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuquan Zhang, Doctor | Affiliated Hospital of Nantong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ustc | Hefei | Anhui | 230031 | China | ||
| Zhongshan City People's Hospital |
Not planning sharing at present.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Zhongshan |
| Guangdong |
| China |
| The Second Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226001 | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226006 | China |
| Affiliated Nantong Hospital Of Shanghai University | Nantong | Jiangsu | China |
| Nantong Maternal and Child Health Hospital | Nantong | Jiangsu | China |
| Children's Hospital of Fudan University Qidong Branch | Qidong | Jiangsu | China |
| Jiujiang Maternal and Child Health Hospital | Jiujiang | Jiangxi | China |
| Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi | 330006 | China |
| Changning District Maternal and Child Health Care Hospital | Shanghai | Shanghai Municipality | 200051 | China |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided