Postmenopausal Women With Vaginal Microbiota
High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women
1 other identifier
observational
1
1 country
1
Brief Summary
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2018
CompletedStudy Start
First participant enrolled
December 25, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 29, 2019
August 1, 2019
11 months
December 21, 2018
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Vaginal microbiota and HR-HPV infection in menopausal women
The persistence vaginal organism in HPV infection menopausal women
6 months
Secondary Outcomes (2)
The difference of vaginal microbiota in different age groups
6 months
The difference of vaginal microbiota in different age groups
6 months
Study Arms (4)
Group A,
High-risk HPV infection in postmenopausal women
Group B
High-risk HPV negative in postmenopausal women
Group C
High-risk HPV infection in gestational women
Group D
High-risk HPV negative in gestational women
Interventions
The participants were assigned to different groups according to the results of HPV detection.
Eligibility Criteria
The participants sample was referred to the paper already published.
You may qualify if:
- Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
You may not qualify if:
- Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 26, 2018
Study Start
December 25, 2018
Primary Completion
December 1, 2019
Study Completion
July 1, 2020
Last Updated
August 29, 2019
Record last verified: 2019-08