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Clinical Trials/NCT01833780
NCT01833780UnknownNot Applicable

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

The Baruch Padeh Medical Center, Poriya0 sitesStarted: May 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Primary Endpoint
Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria

  • Known GBS pregnant women at 35-37 weeks

Outcomes

Primary Outcomes

Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Yuri perlitz

Director, High Risk Unit, Department of OB&GYN, The Baruch Padeh Medical Center, Poriya

The Baruch Padeh Medical Center, Poriya

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