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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01833780
Other study ID # GBS PCR .CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 8, 2013
Last updated April 17, 2013
Start date May 2013

Study information

Verified date April 2013
Source The Baruch Padeh Medical Center, Poriya
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria:

- Known GBS pregnant women at 35-37 weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya Clalit Health Services

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
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Not yet recruiting NCT03064672 - Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial N/A
Completed NCT02883270 - Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome N/A
Completed NCT04434391 - QF-PCR In GBS Diagnosis During Pregnancy
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