QF-PCR In GBS Diagnosis During Pregnancy
Condition: GBS
Study type: Observational

Summary: 
      Estimate the sensitivity and specificity of Quantitative Fluorescence Polymerase Chain
      Reaction (QF-PCR) in diagnosing Group B Strep (GBS) rectovaginal colonization during
      pregnancy, and follow the outcome of the mothers and infants. According to the outcome of
      this study,the investigator wish to determine that wether QF-PCR is an appropriate screening
      method for GBS in primary hospitals in China.
    

Detailed description: 
      This is a study which include 300 pregnant women who will deliver their babies in PUMCH.

        1. Obtain vaginal and rectal swab for Group B Strep (GBS) culture and Quantitative
           Fluorescence Polymerase Chain Reaction (QF-PCR) test between 35-37 weeks.

        2. Obtain intrauterine swabs of the woman whose vaginal-rectal GBS test is positive,for
           both GBS culture and GBS QF-PCR.

        3. Obtain rectal and pharynx swabs of the newborns of the woman whose vaginal-rectal GBS
           test is positive,for both GBS culture and GBS QF-PCR.

        4. Blood test for GBS culture and GBS QF-PCR will be carried out to all the babies
           transferred to neonatal intensive care unit(NICU).

        5. For all the samples that GBS culture result was not consistent with QF-PCR, We will do
           gene sequencing for verification.

        6. Pregnant outcome will be followed such as Apgar score,neonatal pneumonia, urinary tract
           infection, chorioamnionitis, endometritis,sepsis, and bacteremia,It also can cause focal
           infections such as pneumonia, meningitis, and endocarditis.

      Inclusion Criteria:

      1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age or
      older. 3.Plan to deliver baby in Peking Union Medical College Hospital (PUMCH).

      Exclusion Criteria:

        1. Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ
           transplant; chronic steroid therapy; autoimmune disease requiring treatment during
           pregnancy, and other immunocompromised states); Type 1 diabetes and type 2
           diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic
           prophylaxis during procedure/labor; pulmonary disease; renal disease; chronic hepatic
           disease; inflammatory bowel disease; stomach or duodenal ulcer; bowel resection, gastric
           bypass, and chronic indwelling venous, bladder, or gastric catheter.

        2. Multi-fetal gestation.

        3. Chronic (daily) use of broad spectrum antibiotics. 4。Prolonged antibiotic use (> 7 days)
           in the 4 weeks prior to GBS culture screening.

      5.History of infant with GBS sepsis. 6.intrauterine growth retardation(IUGR), Fetal
      Anomalies-major diagnosed at time of second trimester anatomy ultrasound.
    

Intervention name(s): QF-PCR for GBS screening
Intervention type(s): Other
Intervention description(s): QF-PCR for GBS screening in pregnant women,compared with GBS culture test.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          -  1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age
             or older. 3.Plan to deliver baby in PUMCH.
      
Keywords: GBS screening; pregnancy outcome; QF-PCR