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Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery 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: NCT00330642
Recruitment Status : Withdrawn (HandyLab device did not work for the science)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 (GBS) growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor.

Condition or disease
Streptococcal Infections

Detailed Description:
Group B Strep neonatal infections is one of the leading infections in newborns, most 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 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 5 weeks prior to their due date and then treat those with GBS when they come in for 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 un-selected sequential women presenting to labor and delivery, comparing them to cultures taken at the same time and the 35-37 week cultures in these same women. We will also evaluate the identification of GBS before and after rupture of membranes (amniotomy) using both standard GBS culture and rapid PCR (HandyLab technology).

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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: Labor and Delivery Study
Study Start Date : July 2006
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

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 induction of labor.

Inclusion Criteria:

  • Women 18 years of age or older
  • Mentally capable of giving informed consent
  • Symptoms and signs at presentation related to possible labor or ruptured membranes (leakage of fluid, uterine contractions, pelvic pressure)
  • Presentation for induction of labor irrespective of cause

Exclusion Criteria:

  • Inability to give informed consent
  • Conditions where the time taken to obtain specimens are potentially harmful to one or one's baby (heavy bleeding, low fetal heart rate, preterm premature rupture of membranes)
  • Use of any antibacterials 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): NCT00330642

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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 and 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: NCT00330642    
Other Study ID Numbers: HandyLab #VVP00103
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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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections