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

Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study

Sponsors

Lead Sponsor: University of Michigan

Source 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.

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.

Overall Status Withdrawn
Start Date July 2006
Primary Completion Date July 2006
Study Type Observational
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mark D Pearlman, MD Principal Investigator University of Michigan, Obstetrics & Gynecology
Location
Facility: University of Michigan Hospital
Location Countries

United States

Verification Date

December 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: Mark Pearlman

Investigator Title: S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov