Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study

This study has been withdrawn prior to enrollment.
(HandyLab device did not work for the science)
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00330642
First received: May 26, 2006
Last updated: July 23, 2007
Last verified: July 2007
  Purpose

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
Streptococcal Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: Labor and Delivery Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Estimated Enrollment: 350
Estimated Study Completion Date: May 2007
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330642

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

Publications:

ClinicalTrials.gov Identifier: NCT00330642     History of Changes
Other Study ID Numbers: HandyLab #VVP00103
Study First Received: May 26, 2006
Last Updated: July 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Streptococcus Group B
Pregnancy

Additional relevant MeSH terms:
Streptococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on October 30, 2014