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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00331019
Recruitment Status : Withdrawn (HandyLab device determined to not work for the science)
First Posted : May 29, 2006
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Mark Pearlman, University of Michigan

Brief 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.

Condition or disease
Group B Streptococcus Neonatal Sepsis

Detailed 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 fluorescent 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 antenatal clinics at the University of Michigan compared to standard culture.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study
Study Start Date : July 2006
Actual Primary Completion Date : July 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older who present for prenatal cultures in clinic at 35-37 weeks.

Inclusion Criteria:

  • Women 18 years of age or older
  • Mentally capable of giving informed consent
  • Presentation for regularly scheduled 35-37 week cultures

Exclusion Criteria:

  • Inability to give informed consent
  • Evidence of ruptured membranes by clinical or laboratory criteria
  • Use of any antibiotic within the previous 7 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331019

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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Mark D Pearlman, MD University of Michigan, Obstetrics & Gynecology

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Responsible Party: Mark Pearlman, S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School, University of Michigan Identifier: NCT00331019    
Other Study ID Numbers: HandyLab #VVP00056
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by Mark Pearlman, University of Michigan:
Streptococcus Group B
Additional relevant MeSH terms:
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Neonatal Sepsis
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes