Inflammation and Treatment of Bacterial Vaginosis Near Term

Bacterial Vaginosis Clinical Trial

Official title:

Inflammation and Treatment of Bacterial Vaginosis Near Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720291
• Other study ID #: HR # 17069
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: November 23, 2010

Study information

• Verified date: January 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 23, 2010
• Est. primary completion date: November 23, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Inflammation
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole
Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
• Placebo
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha		3-5 days after start of treatment