Inflammation and Treatment of Bacterial Vaginosis Near Term

Completed · Not applicable · Has a placebo group

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT00720291

Run by

Medical University of South Carolina

People needed

59

Starts

2006-02-01

Expected to finish

2010-11-23

Last updated by the study team

2018-07-27

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 32 weeks gestation or greater
• Multiparity
• No history of preterm birth
• English speaking
• Ability to provide informed consent
• Bacterial vaginosis by gram stain

You may not qualify if…

• Acute infections at any site
• Active autoimmune disease
• Current anti-inflammatory use
• Symptomatic bacterial vaginosis
• Previous adverse reaction to metronidazole
• Reports ongoing ethanol consumption

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.