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NCT00720291 · ClinicalTrials.gov registry record · NA

Inflammation and Treatment of Bacterial Vaginosis Near Term

A NA study, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
59
Enrollment target

NCT00720291: Completed NA study, sponsored by Medical University of South Carolina.

NCT00720291 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00720291, a NA study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
59 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG Metronidazole

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2006-02
Est. Completion 2010-11-23
Phase NA

What the finished NCT00720291 record still lists

NCT00720291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00720291 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00720291 about?

NCT00720291 is a clinical study titled "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, t...

What is the current status of trial NCT00720291?

This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2006-02. Estimated completion is 2010-11-23.

What interventions are being tested in trial NCT00720291?

The interventions under investigation include: Placebo (DRUG), Metronidazole (DRUG).

Who is sponsoring clinical trial NCT00720291?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00720291's enrollment target sits among peer trials

59 1256th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00720291, the US trial registry maintained by the National Library of Medicine. NCT00720291 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.