GBSNCT01833780
Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening
An observational study of GBS, run by The Baruch Padeh Medical Center, Poriya.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- GBS
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2013to Dec 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Unknown GBS pregnant women
Who may be able to join
- Unknown GBS pregnant women at 35-37 weeks
Who cannot join
- Known GBS pregnant women at 35-37 weeks
About this study
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.
- Conditions
- GBS
- Keywords
- carriage status, Culture, PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GBS carriage status | Not described | |
| GBS status during labor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Yuri perlitz, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833780
- Sponsor's protocol ID
- GBS PCR .CTIL
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 18 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening
- ClinicalTrials.gov ID
- NCT01833780
- Acronym / sponsor ID
- GBS PCR .CTIL
- Conditions
- GBS
- Keywords
- carriage status, Culture, PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- Clalit Health Services
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBS carriage status | – | – |
| GBS status during labor | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unknown GBS pregnant women
Key inclusion criteria (1 listed)
- Unknown GBS pregnant women at 35-37 weeks
Key exclusion criteria (1 listed)
- Known GBS pregnant women at 35-37 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of GBS, run by The Baruch Padeh Medical Center, Poriya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.