Bacterial Vaginosis
Conditions
Keywords
Metronidazole, BV, Pregnancy
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.
Interventions
DRUGMetronidazole
Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
DRUGPlacebo
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha | 3-5 days after start of treatment |
Countries
United States
Outcome results
None listed