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Bacterial Vaginosis | Inflammation and Treatment of Bacterial Vaginosis Near Term

Bacterial Vaginosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 32 weeks gestation or greater - Multiparity - No history of preterm birth - English speaking - Ability to provide informed consent - Bacterial vaginosis by gram stain Exclusion Criteria: - Acute infections at any site - Active autoimmune disease - Current anti-inflammatory use - Symptomatic bacterial vaginosis - Previous adverse reaction to metronidazole - Reports ongoing ethanol consumption

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacterial Vaginosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MetronidazolePatients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days

Drug:PlaceboPatients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MetronidazoleSubjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.

PlaceboSubjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.

Study Status

Completed

Start Date: February 2006

Completed Date: November 23, 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Heather Norton, MD

Lead Sponsor: Medical University of South Carolina

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00720291

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