Inflammation and Treatment of Bacterial Vaginosis Near Term

NCT00720291 | Completed

• 1 other identifier: HR # 17069
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metronidazole; BV; Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  3-5 days after start of treatment

Study Arms (2)

Metronidazole

ACTIVE COMPARATOR

Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.

Drug: Placebo

Interventions

Metronidazole DRUG

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

Also known as: Flagyl, CAS# 443-48-1

Metronidazole

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• weeks gestation or greater
• Multiparity
• No history of preterm birth
• English speaking
• Ability to provide informed consent
• Bacterial vaginosis by gram stain

You may not qualify if:

• Acute infections at any site
• Active autoimmune disease
• Current anti-inflammatory use
• Symptomatic bacterial vaginosis
• Previous adverse reaction to metronidazole
• Reports ongoing ethanol consumption

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Heather Norton, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: July 22, 2008
• Study Start: February 1, 2006
• Primary Completion: November 23, 2010
• Study Completion: November 23, 2010
• Last Updated: July 27, 2018

Record last verified: 2010-01

Locations

US (1)