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