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

NCT ID: NCT01833780

Last Updated: 2013-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Brief Summary

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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

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Conditions

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GBS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GBS carriage status

No interventions assigned to this group

GBS status during labor

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria

* Known GBS pregnant women at 35-37 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yuri perlitz

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GBS PCR .CTIL

Identifier Type: -

Identifier Source: org_study_id

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