GBS Clinical Trial
Official title:
The Implementation of Real-time PCR for Detection of Intrapartum GBS (Group B Streptococcus) Colonization as a Way to Reduce Antibiotic Prophylaxis Usage
The implementation of real-time PCR for detection of intrapartum GBS (group B Streptococcus) colonization as a way to reduce antibiotic prophylaxis usage.
The investigators intend to perform a cohort prospective trial in the delivery ward of CARMEL
medical center. Pregnant women that are admitted to our ward and need to receive GBS (group B
Streptococcus) prophylaxis either due to a positive GBS culture screen done at 35-37 weeks or
by having risk factors for prophylactic antibiotic treatment (prolonged rupture of membranes,
preterm delivery, GBS bacteriuria during current pregnancy) will be tested by a double
vaginal swab (PCR and culture). Pregnant women that were screened positive at 35-37 weeks,
those who had GBS bacteriuria during pregnancy and those who labor prematurely will be tested
upon admission. Patients that have prolonged rupture of membranes (18 hours) will be tested
by a double vaginal swab after 17 hours and prior to antibiotics administration.
All patient will be treated with GBS prophylactic antibiotics according to the culture screen
done at 35-37 weeks or by risk factors (current protocol guidelines). Culture and PCR will be
sent to the lab and the results will be revealed after delivery (the staff and patients will
be blinded to the results of the culture and PCR until after delivery) in order to assess the
number of patients that were treated with antibiotics unnecessarily.
The investigators intend to recruit 300 patients of which half will need antibiotics because
of a positive culture at 35-37 weeks and half because of having risk factors. We decided to
omit patients that will have fever during labor (a risk factor that necessitates GBS
prophylaxis) because these patients will receive broad spectrum antibiotics anyway.
The vaginal double swab will be assessed by two different lab tests: The first one for GBS
culture on selective media after enrichment of 16h and the second swab by the Cepheid Xpert
GBS Assay performed on the GeneXpert Dx system which is a qualitative in vitro diagnostic
test designed to detect GBS DNA from vaginal swab specimens, using fully automated real-time
polymerase chain reaction (PCR).
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