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| Sponsor: | Medical University of South Carolina |
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| Information provided by: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00720291 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Bacterial Vaginosis |
Drug: Metronidazole Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Inflammation and Treatment of Bacterial Vaginosis Near Term |
| Estimated Enrollment: | 520 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Metronidazole
Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.
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Drug: Metronidazole
Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
Other Name: Flagyl, CAS# 443-48-1
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Placebo Comparator: Placebo
Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.
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Drug: Placebo
Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
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Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Heather Norton, MD | 8437924500 | nortonh@musc.edu |
| Contact: Laura Goetzl, MD | 8437924500 | goetzl@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Heather Norton, MD | Medical University of South Carolina |
More Information
| Responsible Party: | Heather Norton, MD, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00720291 History of Changes |
| Other Study ID Numbers: | HR # 17069 |
| Study First Received: | February 19, 2008 |
| Last Updated: | January 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Metronidazole BV Pregnancy |
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Inflammation Vaginosis, Bacterial Pathologic Processes Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female Metronidazole |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
