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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2008

Last Updated Date

January 21, 2010

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00720291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Inflammation and Treatment of Bacterial Vaginosis Near Term

Official Title ^ICMJE

Inflammation and Treatment of Bacterial Vaginosis Near Term

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Bacterial Vaginosis

Intervention ^ICMJE

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
Drug: Placebo
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.

Study Arm (s)

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.

Intervention: Drug: Metronidazole
Placebo Comparator: Placebo
Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

520

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00720291

Other Study ID Numbers ^ICMJE

HR # 17069

Has Data Monitoring Committee

Responsible Party

Heather Norton, MD, Medical University of South Carolina

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Heather Norton, MD

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

January 2010

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

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