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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00920530
First received: June 2, 2009
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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.


Condition
Neonatal Infections
Streptococcus Agalactiae

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage at Delivery : a Medico-Economic and Feasibility Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • number of women receiving a useless antibiotic prevention [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • economic outcomes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • epidemiological outcomes for group B streptococcus [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • diagnosis efficacy of the real time PCR [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Vaginal swab


Enrollment: 224
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Real time PCR monitoring
Women giving birth at the St Etienne Teaching Hospital

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All pregnant women having a pregnancy follow up with Streptococcus agalactiae monitoring according with french recommandations.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920530

Locations
France
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Bruno POZZETTO, MD PhD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Clément CAILLAUX, CHU SAINT ETIENNE
ClinicalTrials.gov Identifier: NCT00920530     History of Changes
Other Study ID Numbers: 0808073
Study First Received: June 2, 2009
Last Updated: June 17, 2009
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Screening
real time PCR
Streptococcus agalactiae
Pregnant women

ClinicalTrials.gov processed this record on April 23, 2014