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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by HCA International Limited.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
HCA International Limited
ClinicalTrials.gov Identifier:
NCT00972894
First received: September 8, 2009
Last updated: June 22, 2010
Last verified: September 2009
  Purpose

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
Group B Streptococcus

Study Type: Observational
Study Design: 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

Further study details as provided by HCA International Limited:

Biospecimen Retention:   None Retained

Vaginal culture swabs


Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant females

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972894

Locations
United Kingdom
The Portland Hospital
London, United Kingdom, W1W 5QT
The Portland Women ansd Children's Hospital
London, United Kingdom, W1W 5AH
Sponsors and Collaborators
HCA International Limited
Investigators
Principal Investigator: Simon Bignall Portland Hospital
  More Information

No publications provided

Responsible Party: Dr Bignall, The Portland Hospital
ClinicalTrials.gov Identifier: NCT00972894     History of Changes
Other Study ID Numbers: CTO/08/024
Study First Received: September 8, 2009
Last Updated: June 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by HCA International Limited:
Group B streptococcus
Polymerase chain reaction
PCR
Intrapartum screening
Risk factors
arly onset Group B streptococcus infection

ClinicalTrials.gov processed this record on September 18, 2014