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

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).

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