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Longitudinal Study of Vaginal Flora
This study has been completed.
First Received: June 19, 2006   Last Updated: September 19, 2008   History of Changes
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00340275
  Purpose

Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection. It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures. During pregnancy it has been associated with an increased risk of preterm birth an postpartum maternal infection. However, the vaginal microbial flora remains poorly understood.

Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable. This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits). Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews. Routine gynecological and dental examinations will be carried out during the study visits. Samples of vaginal secretion and blood will be collected. Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted. This project is expected to complete in 5 years.


Condition
Vaginal Flora

MedlinePlus related topics: Sexually Transmitted Diseases
U.S. FDA Resources
Study Type: Observational
Official Title: Longitudinal Study of Vaginal Flora

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 5500
Study Start Date: April 1999
Detailed Description:

Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection. It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures. During pregnancy it has been associated with an increased risk of preterm birth an postpartum maternal infection. However, the vaginal microbial flora remains poorly understood.

Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable. This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits). Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews. Routine gynecological and dental examinations will be carried out during the study visits. Samples of vaginal secretion and blood will be collected. Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted. This project is expected to complete in 5 years.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • ELIGIBILITY CRITERIA:

Females, age 15-44.

Since bacterial vaginosis is primarily a condition of reproductive-age women, this study will be restricted to women regarded by demographers as reproductive age.

Non-pregnant

Women whose last menstrual period is later than expected will undergo a urine pregnancy test. Women who become pregnant while on study will complete their next regularly scheduled study visit, following which their participation will terminate.

EXCLUSION CRITERIA:

  1. Immunocompromised status

    Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive drugs.

    Receiving or expected to receive in the next 12 months one or more 30-day courses of corticosteroids.

    Congenital or acquired immune deficiency; known HIV positivity.

  2. Primary or secondary affective disorder, psychosis, emotional or intellectual limitations that preclude informed consent.
  3. Non-fluency in English.
  4. Post-menopausal (natural or surgical).
  5. Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.
  6. Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the next 12 months.
  7. Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in the next 12 months.
  8. Planning to move out of the area in the next 12 months.
  9. Participating or expected to participate during the next 12 months in a clinical trial in which antibiotics or topical microbicides will be administered in a blinded manner.
  10. Women who unexpectedly develop one of these conditions during their participation will continue to be followed, unless a specific contraindication arises.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340275

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 999999023, OH99-CH-N023
Study First Received: June 19, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00340275     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bacterial Vaginosis
Vaginal Infection
Vaginitis
Cohort Study
Sexually Transmitted Disease

Study placed in the following topic categories:
Vaginosis, Bacterial
Vaginitis
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 07, 2009