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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
Sponsor:
Information provided by:
Medical University of South Carolina

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Metronidazole Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Metronidazole
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.
 Drug: Placebo
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.


Outcome Measures
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Primary Outcome Measures :
  1. Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha [ Time Frame: 3-5 days after start of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Heather Norton, MD 8437924500 nortonh@musc.edu
Contact: Laura Goetzl, MD 8437924500 goetzl@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Heather Norton, MD Medical University of South Carolina
More Information
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Responsible Party: Heather Norton, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00720291     History of Changes
Other Study ID Numbers: HR # 17069
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: January 2010

Keywords provided by Medical University of South Carolina:
Metronidazole
BV
Pregnancy

Additional relevant MeSH terms:
Inflammation
Vaginal Diseases
Vaginosis, Bacterial
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
 Vaginitis
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents