Status:
COMPLETED
QF-PCR In GBS Diagnosis During Pregnancy
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
GBS
Eligibility:
FEMALE
22-45 years
Brief 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 ou...
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 Cha...
Eligibility Criteria
Inclusion
- Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age or older. 3.Plan to deliver baby in PUMCH.
Exclusion
- 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.
- 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.
- 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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04434391
Start Date
August 1 2013
End Date
February 1 2014
Last Update
June 16 2020
Active Locations (1)
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1
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730