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Inflammation and Treatment of Bacterial Vaginosis Near Term

NCT00720291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-07-27

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

Metronidazole

Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days

DRUG

Placebo

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Heather Norton, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-11-23
Completion
2010-11-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00720291 on ClinicalTrials.gov