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

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ClinicalTrials.gov Identifier: NCT00920530
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : June 18, 2009
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Condition or disease
Neonatal Infections Streptococcus Agalactiae

Study Type : Observational
Actual Enrollment : 224 participants
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
Study Start Date : November 2008
Primary Completion Date : January 2009
Study Completion Date : June 2009

Real time PCR monitoring
Women giving birth at the St Etienne Teaching Hospital

Primary Outcome Measures :
  1. number of women receiving a useless antibiotic prevention [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. economic outcomes [ Time Frame: 1 day ]
  2. epidemiological outcomes for group B streptococcus [ Time Frame: 1 day ]
  3. diagnosis efficacy of the real time PCR [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
Vaginal swab

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

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

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 ClinicalTrials.gov identifier (NCT number): NCT00920530

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

Responsible Party: Clément CAILLAUX, CHU SAINT ETIENNE
ClinicalTrials.gov Identifier: NCT00920530     History of Changes
Other Study ID Numbers: 0808073
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009

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