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

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.
 
ClinicalTrials.gov Identifier: NCT01829204
Recruitment Status : Recruiting
First Posted : April 11, 2013
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief Summary:
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 or disease
Vulvodynia Mycoses Bacterial Vaginosis Preterm Labor

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
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
Study Start Date : April 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Group/Cohort
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



Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Gary Ventolini, MD TTUHSC PB
Additional Information:
Publications:
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01829204    
Other Study ID Numbers: L13-054
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Mycoses
Vaginosis, Bacterial
Obstetric Labor, Premature
Vulvodynia
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Obstetric Labor Complications
Pregnancy Complications
Vulvar Diseases