Patients With Chronic Pelvic Pain With Vaginal Microbiota | NCT03786588

Studies
Patients With Chronic Pelvic Pain With Vaginal Microbiota

NCT03786588

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Aug 29, 2019Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Pelvic Pain

Interventions

Observation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 25, 2018Actual

Primary Completion Date

Dec 25, 2019Estimated

Completion Date

Dec 25, 2020Estimated

First Submitted Date

Dec 21, 2018

First Submission Date that Met QC Criteria

Dec 21, 2018

First Posted Date

Dec 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2019

Last Update Posted Date

Aug 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Vaginal microbiota in gestation CPP women without HPV infection	Other: Observation
GroupB		Vaginal microbiota in gestation women without CPP and HPV infection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal microbiota difference	Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Gestational participants without HPV infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shu Wang	Contact	+86-18810535568		chaoxp_pumch@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided