CompletedNot Applicable

QF-PCR In GBS Diagnosis During Pregnancy

China300 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range22 Years – 45 Years

SexFEMALE

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Exclusion criteria

✕.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)

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT04434391

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-12

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