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OpenTrials
Completed

NCT Number: NCT00720291

Inflammation and Treatment of Bacterial Vaginosis Near Term

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole

Drug

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

Other names: Flagyl, CAS# 443-48-1

Placebo

Drug

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

Primary outcomes

  1. Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

    Time frame: 3-5 days after start of treatment

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2008
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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