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Group B Streptococcus (GBS) Polymerase Chain Reaction (PCR) Concordance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972894
Recruitment Status : Unknown
Verified September 2009 by HCA International Limited.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2009
Last Update Posted : June 23, 2010
Information provided by:
HCA International Limited

Brief 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. 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.

Condition or disease
Group B Streptococcus

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Study Type : Observational
Estimated Enrollment : 500 participants
Time Perspective: Prospective
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
Study Start Date : January 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Biospecimen Retention:   None Retained
Vaginal culture swabs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant females

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Scheduled for non vaginal birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972894

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United Kingdom
The Portland Women ansd Children's Hospital
London, United Kingdom, W1W 5AH
The Portland Hospital
London, United Kingdom, W1W 5QT
Sponsors and Collaborators
HCA International Limited
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Principal Investigator: Simon Bignall Portland Hospital
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Responsible Party: Dr Bignall, The Portland Hospital Identifier: NCT00972894    
Other Study ID Numbers: CTO/08/024
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: June 23, 2010
Last Verified: September 2009
Keywords provided by HCA International Limited:
Group B streptococcus
Polymerase chain reaction
Intrapartum screening
Risk factors
arly onset Group B streptococcus infection