Inflammation and Treatment of Bacterial Vaginosis Near Term
Status: | Completed |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 7/29/2018 |
Start Date: | February 2006 |
End Date: | November 23, 2010 |
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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