Inflammation and Treatment of Bacterial Vaginosis Near Term
- Registration Number
- NCT00720291
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 59
- 32 weeks gestation or greater
- Multiparity
- No history of preterm birth
- English speaking
- Ability to provide informed consent
- Bacterial vaginosis by gram stain
- Acute infections at any site
- Active autoimmune disease
- Current anti-inflammatory use
- Symptomatic bacterial vaginosis
- Previous adverse reaction to metronidazole
- Reports ongoing ethanol consumption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metronidazole Metronidazole Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV. Placebo Placebo Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.
- Primary Outcome Measures
Name Time Method Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha 3-5 days after start of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States