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

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.

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 Overview

• Status: Unknown
• Conditions: Group B Streptococcus

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W1W 5AH
    • The Portland Women ansd Children's Hospital
  • London, United Kingdom, W1W 5QT
    • The Portland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant females

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: HCA International Limited
• Investigators: Principal Investigator: Simon Bignall, Portland Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2010
• Last Update Submitted That Met QC Criteria: June 22, 2010
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: PCR; Risk factors; Polymerase chain reaction; Group B streptococcus; Intrapartum screening; arly onset Group B streptococcus infection
• Other Study ID Numbers: CTO/08/024