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

Completed
Conditions
Neonatal Infections
Streptococcus Agalactiae
Registration Number
NCT00920530
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
224
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
number of women receiving a useless antibiotic prevention1 day
Secondary Outcome Measures
NameTimeMethod
diagnosis efficacy of the real time PCR1 day
epidemiological outcomes for group B streptococcus1 day
economic outcomes1 day

Trial Locations

Locations (1)

CHU de Saint-Etienne

🇫🇷

Saint-etienne, France

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