The Implementation of Real-time PCR - Intrapartum GBS (Group B Streptococcus) Colonization to Reduce Antibiotic Prophylaxis
Condition: GBS
Study type: Observational

Summary: 
      The implementation of real-time PCR for detection of intrapartum GBS (group B Streptococcus)
      colonization as a way to reduce antibiotic prophylaxis usage.
    

Detailed description: 
      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).
    

Intervention name(s): GBS vaginal double swab
Intervention type(s): Other
Intervention description(s): 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).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of 300 patient admitted to the labor ward in CARMEL medical center that need
        prophylactic antibiotics for GBS because of culture screen at 35-37 weeks or because of
        having risk factors.