Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340275
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Longitudinal Study of Vaginal Flora
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Longitudinal Study of Vaginal Flora
Status:
COMPLETED
Status Verified Date:
2010-11-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH99-CH-N023 | None | None | None |