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Prospective Data Bank Creation to Study Vaginal Conditions (CRIPB-13-002)

This study is currently recruiting participants.
Verified November 2016 by Texas Tech University Health Sciences Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01829204
First Posted: April 11, 2013
Last Update Posted: November 10, 2016
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.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
  Purpose
The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.

Condition
Vulvodynia Mycoses Bacterial Vaginosis Preterm Labor

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Cytokines Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]
    To determine types of cytokines normally present in women's vagina and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor


Secondary Outcome Measures:
  • Proteins Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]
    The vaginal milieu will respond to the insult by developing an inflammatory reaction characterized by protein production (in terms of increased protein concentration according to the Bradford protein assay).

  • Lactobacillus determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]
    Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing lactobacillus microflora alteration.


Estimated Enrollment: 550
Study Start Date: April 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non pregnant asymptomatic
Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination
Non pregnant symptomatic
Non-pregnant women ages 12 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant asymptomatic
Pregnant women ages 12 to 75 years who are both asymptomatic and healthy
Pregnant symptomatic
Pregnant women ages 12 to 75 who have any gynecological vulvovaginal condition

  Hide Detailed Description

Detailed Description:

Our approach specifically targets the evaluation of the proteins and cytokines present and the bacteriological analysis of the microflora in the vaginal milieu.

Conjectures:

  • An initial insult in the vagina (possibly involving a bacterial, viral or fungal organism or their products) causes modifications in the vaginal milieu
  • The vaginal milieu responds to the insult by developing an inflammatory reaction characterized by cytokine and protein production
  • Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing a reaction, chemical irritation or micro flora alteration by changes in proteins and/or abnormal protein production
  • Those changes eventually result in hypersensitivity, irritation, burning, and pain manifested in patients with vulvodynia. And those changes may also result in the recurrence of fungal or bacterial infections
  • Those changes may also contribute to initiate the cascade of premature events conducting to cervical effacement and dilation observed in preterm labor

The conjectures will be investigated by using a multidisciplinary approach including: microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will be comparing an asymptomatic female population to serve as a baseline to patients affected by vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy.

This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4) Pregnant women have any gynecological vulvovaginal condition.

We will evaluate the following:

  • Types of cytokines normally present in women and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
  • Normal microbiology flora in women and variations present in the vaginal milieu in these patients
  • The presence of normal and atypical proteins in the vaginal milieu of healthy women and patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
  • Informed consent will be obtained and documented for participation in the study
  • Comprehensive history assessment of environmental factors, topical vulvovaginal issues and co morbid conditions as defined in the exclusion criteria.
  • Pelvic examination to obtain two samples via cotton swabs for proteomics, cytokines, vaginal lactobacillus from vaginal secretions.

A. Swab procedure:

The cotton swabs (2) will be introduced only in the middle vagina, one at the time, no other areas will be sampled.

B. Swab processing One swab will be placed in a special room temperature solution. This de-identified swab will be mailed for Lactobacillus.

The second de-identified swab is to be place in 2 separated micro-containers in Liquid Nitrogen Containers (one for cytokines and one for Proteomics). When 50 samples are completed they will be processed at TTUHSC Permian Basin campus, with the Proteomics testing being done in Lubbock.

Therefore, there are 3 samples, each processed differently. Data will be recorded in a confidential manner with no personal identifiers, only an assigned study subject number. As such, the de-identified data may serve as a database for additional studies. The computer used will belong to TTUHSC and be password protected, access limited to only authorized personnel. Consent forms will be stored separately from the study data in the research office.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients willing to participate, and give informed consent, and Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.

2—Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.

Pregnant women ages 21 to 75 years who are both asymptomatic and healthy Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition

Criteria

Inclusion Criteria:

  • All patients willing to participate, and give informed consent, and
  • Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
  • Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
  • Pregnant women ages 21 to 75 years who are both asymptomatic and healthy
  • Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition

Exclusion Criteria:

  • Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75 years.
  • Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks
  • Patients unable to follow the protocol or unwilling to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829204


Locations
United States, Texas
TTUHSC Permian Basin Recruiting
Midland, Texas, United States, 79701
Contact: Jennifer R Hinojosa, RN    432-335-5113    jennifer.hinojosa@ttuhsc.edu   
Principal Investigator: Gary Ventolini, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Gary Ventolini, MD TTUHSC PB
  More Information

Additional Information:
Publications:
Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01829204     History of Changes
Other Study ID Numbers: L13-054
First Submitted: April 8, 2013
First Posted: April 11, 2013
Last Update Posted: November 10, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Vulvodynia
Mycoses
Vaginosis, Bacterial
Obstetric Labor, Premature
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor Complications
Pregnancy Complications
Vulvar Diseases