Inflammation and Treatment of Bacterial Vaginosis Near Term
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|ClinicalTrials.gov Identifier: NCT00720291|
Recruitment Status : Unknown
Verified January 2010 by Medical University of South Carolina.
Recruitment status was: Recruiting
First Posted : July 22, 2008
Last Update Posted : January 25, 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.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: Metronidazole Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Inflammation and Treatment of Bacterial Vaginosis Near Term|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
Active Comparator: Metronidazole
Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.
Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
Other Name: Flagyl, CAS# 443-48-1
Placebo Comparator: Placebo
Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
- Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha [ Time Frame: 3-5 days after start of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720291
|Contact: Heather Norton, MDfirstname.lastname@example.org|
|Contact: Laura Goetzl, MDemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Heather Norton, MD||Medical University of South Carolina|