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Inflammation and Treatment of Bacterial Vaginosis Near Term

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: Metronidazole (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Heather Norton, MD, Principal Investigator, Affiliation: Medical University of South Carolina

Overall contact:
Heather Norton, MD, Phone: 8437924500, Email: nortonh@musc.edu


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.

Clinical Details

Official title: Inflammation and Treatment of Bacterial Vaginosis Near Term

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

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


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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

Locations and Contacts

Heather Norton, MD, Phone: 8437924500, Email: nortonh@musc.edu

Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Additional Information

Starting date: February 2006
Last updated: January 21, 2010

Page last updated: August 23, 2015

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