Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330642
Status:
WITHDRAWN
Last Update Posted:
2015-12-15
First Post:
2006-05-26
Brief Title:
Rapid Detection of Group B Streptococcus Strep-Labor and Delivery Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device Labor and Delivery Study
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
HandyLab device did 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 GBS growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor
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
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