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Inflammation and Treatment of Bacterial Vaginosis Near Term


N/A
18 Years
45 Years
Open (Enrolling)
Female
Bacterial Vaginosis

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Trial Information

Inflammation and Treatment of Bacterial Vaginosis Near Term


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3-5 days after start of treatment

Safety Issue:

Yes

Principal Investigator

Heather Norton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

HR # 17069

NCT ID:

NCT00720291

Start Date:

February 2006

Completion Date:

December 2009

Related Keywords:

  • Bacterial Vaginosis
  • Metronidazole
  • BV
  • Pregnancy
  • Inflammation
  • Vaginosis, Bacterial

Name

Location
Medical University of South Carolina Charleston, South Carolina  29425-0721