Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT04434391
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.
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Notify Me22 year–45 year
Female
Observational
Beijing, Beijing Municipality, 100730, China
This is a study which include 300 pregnant women who will deliver their babies in PUMCH.
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
5.History of infant with GBS sepsis. 6.intrauterine growth retardation(IUGR), Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.IUGR, Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound。 7.Anticipated delivery <35 wks for maternal/fetal indication 8.Placenta previa or accreta (with anticipated delivery prior to 35 weeks)
QF-PCR for GBS screening in pregnant women,compared with GBS culture test.
Time frame: 3 months
The percentage will be calculated separately as follows:
Time frame: 3 months
Compare the maternal ante- intra- and postpartum outcomes (urinary tract infections, chorioamnionitis, endometritis, cellulitis, bacteremia, sepsis, and other infectious morbidity) and neonatal outcomes (gestational age at delivery, APGAR scores, bilirubin levels, C-reactive protein, rule out sepsis evaluation, sepsis, pneumonia, meningitis, neonatal ICU admission, and length of hospital stay).
Peking Union Medical College Hospital
Other
Quantitative Fluorescence Polymerase Chain Reaction (QF-PCR) in Group B Strep (GBS) Rectovaginal Colonization Diagnosis During Pregnancy.
Acronym: QFPCRIGDDP
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