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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT00920530
Collaborator
(none)
224
Enrollment
1
Location
7
Duration (Months)
32.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Nov 1, 2008
    Actual Primary Completion Date :
    Jan 1, 2009
    Actual Study Completion Date :
    Jun 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Real time PCR monitoring

    Women giving birth at the St Etienne Teaching Hospital

    Outcome Measures

    Primary Outcome Measures

    1. number of women receiving a useless antibiotic prevention [1 day]

    Secondary Outcome Measures

    1. economic outcomes [1 day]

    2. epidemiological outcomes for group B streptococcus [1 day]

    3. diagnosis efficacy of the real time PCR [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00920530
    Other Study ID Numbers:
    • 0808073
    First Posted:
    Jun 15, 2009
    Last Update Posted:
    Jun 18, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Screening
    real time PCR
    Streptococcus agalactiae
    Pregnant women

    Study Results

    No Results Posted as of Jun 18, 2009