Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 17, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedApril 18, 2013
April 1, 2013
7 months
April 8, 2013
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation
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.
One year
Study Arms (2)
GBS carriage status
GBS status during labor
Eligibility Criteria
Unknown GBS pregnant women
You may qualify if:
- Unknown GBS pregnant women at 35-37 weeks
You may not qualify if:
- Known GBS pregnant women at 35-37 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Baruch Padeh Medical Center, Poriyalead
- Clalit Health Servicescollaborator
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, High Risk Unit, Department of OB&GYN, The Baruch Padeh Medical Center, Poriya
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 17, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2013
Last Updated
April 18, 2013
Record last verified: 2013-04