Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00720291
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2008-02-19
Brief Title:
Inflammation and Treatment of Bacterial Vaginosis Near Term
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Inflammation and Treatment of Bacterial Vaginosis Near Term
Status:
COMPLETED
Status Verified Date:
2010-01
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:
Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth Despite this there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth However treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment however this direct pathway has not been elucidated The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth
This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha
This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None