GBS Clinical Trial
Official title:
Quantitative Fluorescence Polymerase Chain Reaction (QF-PCR) in Group B Strep (GBS) Rectovaginal Colonization Diagnosis During Pregnancy.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04116645 -
Time Frame for GBS Screening
|
||
Not yet recruiting |
NCT01833780 -
Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening
|
N/A | |
Completed |
NCT02497430 -
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
|
N/A | |
Completed |
NCT03936816 -
The Implementation of Real-time PCR - Intrapartum GBS (Group B Streptococcus) Colonization to Reduce Antibiotic Prophylaxis
|
||
Completed |
NCT03008421 -
Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy
|
N/A | |
Not yet recruiting |
NCT03064672 -
Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02883270 -
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome
|
N/A | |
Recruiting |
NCT04871035 -
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
|