Longitudinal Study of Vaginal Flora
Condition: Vaginal Flora
Study type: Observational

Summary: 
      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.
    

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 and 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.
    

Keywords: Bacterial Vaginosis; Vaginal Infection; Vaginitis; Cohort Study; Sexually Transmitted Disease