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Inflammation and Treatment of Bacterial Vaginosis Near Term

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metronidazole
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Metronidazole, BV, Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metronidazole

Placebo

Arm Description

Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.

Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.

Outcomes

Primary Outcome Measures

Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

Secondary Outcome Measures

Full Information

First Posted
February 19, 2008
Last Updated
July 25, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00720291
Brief Title
Inflammation and Treatment of Bacterial Vaginosis Near Term
Official Title
Inflammation and Treatment of Bacterial Vaginosis Near Term
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (Actual)
Primary Completion Date
November 23, 2010 (Actual)
Study Completion Date
November 23, 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Metronidazole, BV, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl, CAS# 443-48-1
Intervention Description
Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
Primary Outcome Measure Information:
Title
Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha
Time Frame
3-5 days after start of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Norton, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Inflammation and Treatment of Bacterial Vaginosis Near Term

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