Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331019
Status:
WITHDRAWN
Last Update Posted:
2015-12-15
First Post:
2006-05-26
Brief Title:
Rapid Detection of Group B Strep- 35-37 Week Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device 35-37 Week Study
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
HandyLab device determined to not work for the science
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None