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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00920530
Acronym
BBFAST
Enrollment
224
Registered
2009-06-15
Start date
2008-11-30
Completion date
2009-06-30
Last updated
2009-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infections, Streptococcus Agalactiae

Keywords

Screening, real time PCR, Streptococcus agalactiae, Pregnant women

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
number of women receiving a useless antibiotic prevention1 day

Secondary

MeasureTime frame
economic outcomes1 day
epidemiological outcomes for group B streptococcus1 day
diagnosis efficacy of the real time PCR1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026