Inflammation and Treatment of Bacterial Vaginosis Near Term

Study Overview
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Brief Summary
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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.

Official Title
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Inflammation and Treatment of Bacterial Vaginosis Near Term

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole<br>Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV. | Drug: Metronidazole<br>* Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days<br>* Other names: Flagyl, CAS# 443-48-1;|
| Placebo Comparator: Placebo<br>Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV. | Drug: Placebo<br>* Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha |  | 3-5 days after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metronidazole, BV, Pregnancy