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Rapid Detection of Group B Strep- 35-37 Week Study

2014-07-23 21:43:37 | BioPortfolio

Summary

The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep growing in the vagina and rectum can be performed with similar success to the routine culture.

Description

Early Onset Group B Strep (GBS) neonatal infections is one of the leading infections in newborns, nearly all of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized with GBS in the vaginal-rectal area and giving these colonized women prophylactic antibiotics in labor. About 15 -20% of women are colonized and nearly all of these women are asymptomatic. Because it takes up to 48 hours to obtain culture results, it is currently recommended to perform cultures in the clinic about 3 - 5 weeks prior to their due date and then prophylaxing those women colonized with GBS with antibiotics when they come in to labor. There are several downsides to this strategy. All women who present with preterm labor are treated until culture results become available (overtreatment), women who go into labor while waiting for culture results are all treated (overtreatment), prior studies have shown 33% of women are positive at 35 weeks, but negative at birth (overtreatment) and 10% are negative at 35 weeks and positive at birth (undertreatment), lost or missing culture results (over- or undertreatment). Using microfluidics and flourescent PCR, a new test can identify GBS reliably in 30 to 45 minutes in vitro. This study proposes to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive value) of the microfluidic rapid GBS technique in selected women presenting at 35 - 37 weeks to antental clinics at the University of Michigan compared to standard culture.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Conditions

Streptococcus Group B

Location

University of Michigan Hospital
Ann Arbor
Michigan
United States
48109

Status

Withdrawn

Source

University of Michigan

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:43:37-0400

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Medical and Biotech [MESH] Definitions

A large heterogeneous group of mostly alpha-hemolytic streptococci. They colonize the respiratory tract at birth and generally have a low degree of pathogenicity. This group of species includes STREPTOCOCCUS MITIS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS ORALIS; STREPTOCOCCUS SANGUIS; STREPTOCOCCUS SOBRINUS; and the STREPTOCOCCUS MILLERI GROUP. The latter are often beta-hemolytic and commonly produce invasive pyogenic infections including brain and abdominal abscesses.

A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is the most frequently seen isolate of that group, has a proclivity for abscess formation, and is most often isolated from the blood, gastrointestinal, and urogenital tract.

A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is commonly found in the oropharnyx flora and has a proclivity for abscess formation in the upper body and respiratory tract.

A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is commonly found in the oropharynx flora and has a proclivity for abscess formation, most characteristically in the CENTRAL NERVOUS SYSTEM and LIVER.

A species of gram-positive, coccoid bacteria isolated from skin lesions, blood, inflammatory exudates, and the upper respiratory tract of humans. It is a group A hemolytic Streptococcus that can cause SCARLET FEVER and RHEUMATIC FEVER.

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