Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening

• Conditions: GBS

• Registration Number: NCT01833780
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

Brief Summary

Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS) test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.

The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to intrapartum PCR GBS and GBS cultures status.

The larger perspective of this trial is to check the possibility of replacing the GBS culture screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18
• Study Start: 2013-05
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria

• Known GBS pregnant women at 35-37 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation	One year	Intrapartum GBS carriage status measured by culture and PCR will be compared to GBS carriage stauts measured by the same tests at 35-37 weeks gestation.