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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01829204
First received: April 8, 2013
Last updated: June 24, 2014
Last verified: June 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2018
Estimated Primary Completion Date: May 2015 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 8, 2013
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014