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NCT00340275 · ClinicalTrials.gov registry record

Longitudinal Study of Vaginal Flora

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
5,500
Enrollment target

NCT00340275: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00340275 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 5,500 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00340275 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
5,500 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 5,500 participants
Start Date 1999-04-14
Est. Completion 2010-11-18

What the finished NCT00340275 record still lists

NCT00340275 is an observational study that tracks outcomes without assigning an intervention. Its 5,500 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT00340275 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00340275 about?

NCT00340275 is a clinical study titled "Longitudinal Study of Vaginal Flora". 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 acquisiti...

What is the current status of trial NCT00340275?

This trial is currently completed. The enrollment target is 5,500 participants. The study started on 1999-04-14. Estimated completion is 2010-11-18.

Who is sponsoring clinical trial NCT00340275?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00340275, the US trial registry maintained by the National Library of Medicine. NCT00340275 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.