Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage: a Medico-Economic Study

Streptococcus Agalactiae Clinical Trial

— BBFAST  

Official title:

Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage at Delivery : a Medico-Economic and Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920530
• Other study ID #: 0808073
• Status: Completed
• Phase: N/A
• First received: June 2, 2009
• Last updated: June 17, 2009
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area. That is why the detection of this bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea in order to give prophylactic antibiotic treatment in case or positive carriage. This strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37 weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women escape from systematic screening, leading to a systematic antibiotic treatment, which means useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time polymerase chain reaction (PCR) allows a rapid detection anytime with no specific microbiological qualification. The aim of the study is to assess the economic outcomes of this strategy and the epidemiological values for St Etienne hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women giving birth

Exclusion Criteria:

• planned caesarian

• minor

• cervical diameter > 5 cm

• women giving birth at less than 35 weeks of amenorrhea

• recent antibiotherapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Infections
• Streptococcus Agalactiae

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of women receiving a useless antibiotic prevention		1 day	No
Secondary	economic outcomes		1 day	No
Secondary	epidemiological outcomes for group B streptococcus		1 day	No
Secondary	diagnosis efficacy of the real time PCR		1 day	No