- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434391
QF-PCR In GBS Diagnosis During Pregnancy (QFPCRIGDDP)
Quantitative Fluorescence Polymerase Chain Reaction (QF-PCR) in Group B Strep (GBS) Rectovaginal Colonization Diagnosis During Pregnancy.
Study Overview
Detailed Description
This is a study which include 300 pregnant women who will deliver their babies in PUMCH.
- Obtain vaginal and rectal swab for Group B Strep (GBS) culture and Quantitative Fluorescence Polymerase Chain Reaction (QF-PCR) test between 35-37 weeks.
- Obtain intrauterine swabs of the woman whose vaginal-rectal GBS test is positive,for both GBS culture and GBS QF-PCR.
- 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.
- Blood test for GBS culture and GBS QF-PCR will be carried out to all the babies transferred to neonatal intensive care unit(NICU).
- For all the samples that GBS culture result was not consistent with QF-PCR, We will do gene sequencing for verification.
- 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:
- 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.
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100730
- Department of ob gyn, Peking Union Medical College Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
QF-PCR for GBS screening
QF-PCR for vaginal-rectal samples in pregnant women
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QF-PCR for GBS screening in pregnant women,compared with GBS culture test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with positive results of GBS culture or/and QF-PCR
Time Frame: 3 months
|
The percentage will be calculated separately as follows:
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse outcomes of pregnancy
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).
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Liangkun MA, MD, Peking Union Medical College
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QF-PCR in GBS screening
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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