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Inflammation and Treatment of Bacterial Vaginosis Near Term
This study is currently recruiting participants.
Study NCT00720291   Information provided by Medical University of South Carolina
First Received: February 19, 2008   Last Updated: July 18, 2008   History of Changes

February 19, 2008
July 18, 2008
February 2006
February 2009   (final data collection date for primary outcome measure)
Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha [ Time Frame: 3-5 days after start of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00720291 on ClinicalTrials.gov Archive Site
 
 
 
Inflammation and Treatment of Bacterial Vaginosis Near Term
Inflammation and Treatment of Bacterial Vaginosis Near Term

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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Bacterial Vaginosis
  • Drug: Metronidazole
  • Drug: Placebo
  • Active Comparator: Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.
  • Placebo Comparator: Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
520
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact: Heather Norton, MD 8437924500 nortonh@musc.edu
Contact: Laura Goetzl, MD 8437924500 goetzl@musc.edu
United States
 
NCT00720291
Heather Norton, MD, Medical University of South Carolina
HR # 17069
Medical University of South Carolina
 
Principal Investigator: Heather Norton, MD Medical University of South Carolina
Medical University of South Carolina
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP