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Patients With Chronic Pelvic Pain With Vaginal Microbiota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786588
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Information provided by (Responsible Party):
shuwang, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment
Pelvic Pain Other: Observation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection
Estimated Study Start Date : December 25, 2018
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : August 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Group/Cohort Intervention/treatment
Group A
Vaginal microbiota in gestation CPP women without HPV infection
Other: Observation
The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.

Vaginal microbiota in gestation women without CPP and HPV infection

Primary Outcome Measures :
  1. Vaginal microbiota difference [ Time Frame: one year ]
    Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
Gestational participants without HPV infection

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.

Additional Information:

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Responsible Party: shuwang, Associate Professor, Peking Union Medical College Hospital Identifier: NCT03786588     History of Changes
Other Study ID Numbers: CPPVM
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pelvic Pain
Neurologic Manifestations
Signs and Symptoms