Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 5,500 participants |
| Start Date | 1999-04-14 |
| Est. Completion | 2010-11-18 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340275
The ClinicalTrials.gov registry entry for NCT00340275 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 5,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00340275 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.