Group B StreptococcusNCT00972894
Group B Streptococcus (GBS) Polymerase Chain Reaction (PCR) Concordance Study
An observational study of Group B Streptococcus, run by HCA International Limited at 2 sites in United Kingdom.
Trial summary
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus. About 10-30% of women carry GBS in the vagina or rectum. During labour this infection can be passed to the neonate. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Group B Streptococcus
- How many people
- 500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Oct 2012
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant females
Who may be able to join
- Patients will be included in the study if they are;
- 18 years or older
- Pregnant and planned admission to Portland Hospital whether full-term or otherwise.
- Willing and able to give informed consent prenatally.
Who cannot join
- Scheduled for non vaginal birth
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Portland Women ansd Children's Hospital
London, W1W 5AH
The Portland Hospital
London, W1W 5QT
About this study
Official title: Prospective Evaluation of a Polymerase Chain Reaction (PCR) Assay (GenExpert DX™) for the Rapid Detection of Recto-vaginal Group B Streptococcus (GBS) Colonisation During Intrapartum Screening
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus. About 10-30% of women carry GBS in the vagina or rectum.
During labour this infection can be passed to the neonate. This can lead to the baby developing a serious infection.
Read more
However, research has shown that if antibiotic treatment is given to GBS carrying women during labour most of these infections can be avoided.
A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less than an hour. In clinical trials conducted in the US and France this method has been shown to be more accurate than either prenatal vaginal swabs or risk factor assessment. For this reason, PCR may be helpful in screening and treating GBS positive women in the UK.
In this study the investigators will compare each of the following three methods of diagnosis to a gold standard.
- Prenatal vaginal culture swab (at 35 to 37 weeks gestation)- The US approach.
- Risk factor assessment (at the time of admission for labour)- The UK approach
- The new PCR test (at the time of your labour admission)
The investigators will compare the accuracy of each of these methods with the most accurate method for determining the GBS status during labour. This 'most accurate' method is a highly sensitive swab test which unfortunately takes several days to produce a result. For this reason this test will not tell the investigators whether prophylactic antibiotics may be useful during labour (Receiving them after birth is ineffective).
If PCR is shown to be a more accurate method of identifying GBS positive women this may help to reduce the number of infections in new born infants and as a result may help to save lives.
- Conditions
- Group B Streptococcus
- Keywords
- Group B streptococcus, Polymerase chain reaction, PCR, Intrapartum screening, Risk factors, arly onset Group B streptococcus infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B StreptococcusStudies 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HCA International Limited
- Sponsor type
- University, hospital or other
- Investigators
- Simon Bignall, Principal investigator, Portland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972894
- Sponsor's protocol ID
- CTO/08/024
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Polymerase Chain Reaction (PCR) Assay (GenExpert DX™) for the Rapid Detection of Recto-vaginal Group B Streptococcus (GBS) Colonisation During Intrapartum Screening
- ClinicalTrials.gov ID
- NCT00972894
- Acronym / sponsor ID
- CTO/08/024
- Conditions
- Group B Streptococcus
- Keywords
- Group B streptococcus, Polymerase chain reaction, PCR, Intrapartum screening, Risk factors, arly onset Group B streptococcus infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- HCA International LimitedUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 9 Sep 2009 (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.
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus. About 10-30% of women carry GBS in the vagina or rectum.
During labour this infection can be passed to the neonate. This can lead to the baby developing a serious infection.
However, research has shown that if antibiotic treatment is given to GBS carrying women during labour most of these infections can be avoided.
A new bedside test known as PCR has been shown to produce a GBS diagnostic result in less than an hour. In clinical trials conducted in the US and France this method has been shown to be more accurate than either prenatal vaginal swabs or risk factor assessment. For this reason, PCR may be helpful in screening and treating GBS positive women in the UK.
In this study the investigators will compare each of the following three methods of diagnosis to a gold standard.
- Prenatal vaginal culture swab (at 35 to 37 weeks gestation)- The US approach.
- Risk factor assessment (at the time of admission for labour)- The UK approach
- The new PCR test (at the time of your labour admission)
The investigators will compare the accuracy of each of these methods with the most accurate method for determining the GBS status during labour. This 'most accurate' method is a highly sensitive swab test which unfortunately takes several days to produce a result. For this reason this test will not tell the investigators whether prophylactic antibiotics may be useful during labour (Receiving them after birth is ineffective).
If PCR is shown to be a more accurate method of identifying GBS positive women this may help to reduce the number of infections in new born infants and as a result may help to save lives.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant females
Key inclusion criteria (4 listed)
- Patients will be included in the study if they are;
- 18 years or older
- Pregnant and planned admission to Portland Hospital whether full-term or otherwise.
- Willing and able to give informed consent prenatally.
Key exclusion criteria (1 listed)
- Scheduled for non vaginal birth
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
Related trials for Group B Streptococcus
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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
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Preparing for Maternal GBS Vaccine Trials in Africa
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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.
Simon Bignall principal investigator
Portland Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcus, run by HCA International Limited at 2 sites in United Kingdom.
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 4 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 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 23 Jun 2010.