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CompletedNCT00920530BBFASTUpdated Jun 18, 2009

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

An observational study in Neonatal Infections and Streptococcus Agalactiae, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-18.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
224
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Neonatal Infections
  • Streptococcus Agalactiae

Keywords

  • Screening
  • real time PCR
  • Streptococcus agalactiae
  • Pregnant women
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • planned caesarian
  • minor
  • cervical diameter > 5 cm
  • women giving birth at less than 35 weeks of amenorrhea
  • recent antibiotherapy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
224 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Real time PCR monitoring

    Women giving birth at the St Etienne Teaching Hospital

06

What researchers measure

Primary outcomes

  1. number of women receiving a useless antibiotic prevention

    Time frame: 1 day

Secondary outcomes

  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

07

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-etienne, 42055, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00920530
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
First posted
Jun 15, 2009
Start date
Nov 2008
Primary completion
Jan 2009
Completion
Jun 2009
Last update
Jun 18, 2009

Study contacts

Bruno POZZETTO, MD PhD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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