Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Inflammation and Treatment of Bacterial Vaginosis Near Term

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00720291
First received: February 19, 2008
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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 Intervention
Bacterial Vaginosis
Drug: Metronidazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Inflammation and Treatment of Bacterial Vaginosis Near Term

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 520
Study Start Date: February 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Heather Norton, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00720291     History of Changes
Other Study ID Numbers: HR # 17069
Study First Received: February 19, 2008
Last Updated: January 21, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014