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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QF-PCR for GBS screening | QF-PCR for vaginal-rectal samples in pregnant women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QF-PCR for GBS screening | Other | QF-PCR for GBS screening in pregnant women,compared with GBS culture test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with positive results of GBS culture or/and QF-PCR | The percentage will be calculated separately as follows:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse outcomes of pregnancy | 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). |
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Inclusion Criteria:
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.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)
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liangkun MA, MD | Peking Union Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ob gyn, Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| 3 months |