Patients With Chronic Pelvic Pain With Vaginal Microbiota
Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection
1 other identifier
observational
1
1 country
1
Brief Summary
Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.
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 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2020
CompletedAugust 29, 2019
August 1, 2019
1 year
December 21, 2018
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Vaginal microbiota difference
Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.
one year
Study Arms (2)
Group A
Vaginal microbiota in gestation CPP women without HPV infection
GroupB
Vaginal microbiota in gestation women without CPP and HPV infection
Interventions
The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.
Eligibility Criteria
Gestational participants without HPV infection
You may qualify if:
- Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
You may not qualify if:
- Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those 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
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- 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 25, 2019
Study Completion
December 25, 2020
Last Updated
August 29, 2019
Record last verified: 2019-08