QF-PCR In GBS Diagnosis During Pregnancy

NCT04434391 | Completed DMC

• 1 other identifier: QF-PCR in GBS screening
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

GBS

Keywords

GBS screening; pregnancy outcome; QF-PCR

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with positive results of GBS culture or/and QF-PCR

  The percentage will be calculated separately as follows: 1. Number of positive GBS culture from vaginal/rectal swabs in all participants; 2. Number of positive GBS QF-PCR from vaginal/rectal swabs in all participants; 3. Number of positive GBS culture/QF-PCR from intrauterine swabs in women whose vaginal-rectal GBS test is positive; 4. Number of positive GBS culture from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive; 5. Number of positive GBS QF-PCR from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive;

  3 months

Secondary Outcomes (1)

• Number of participants with adverse outcomes of pregnancy

  3 months

Study Arms (1)

QF-PCR for GBS screening

QF-PCR for vaginal-rectal samples in pregnant women

Other: QF-PCR for GBS screening

Interventions

QF-PCR for GBS screening OTHER

QF-PCR for GBS screening in pregnant women,compared with GBS culture test.

QF-PCR for GBS screening

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age or older. 3.Plan to deliver baby in PUMCH.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

• Liangkun MA, MD

  Peking Union Medical College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: June 16, 2020
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: June 16, 2020

Record last verified: 2013-12

Locations

CN (1)