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

NCT00920530 | Completed

• 1 other identifier: 0808073
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infections; Streptococcus Agalactiae

Keywords

Screening; real time PCR; Streptococcus agalactiae; Pregnant women

Outcome Measures

Primary Outcomes (1)

• number of women receiving a useless antibiotic prevention

  1 day

Secondary Outcomes (3)

• economic outcomes

  1 day

• epidemiological outcomes for group B streptococcus

  1 day

• diagnosis efficacy of the real time PCR

  1 day

Study Arms (1)

Real time PCR monitoring

Women giving birth at the St Etienne Teaching Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women having a pregnancy follow up with Streptococcus agalactiae monitoring according with french recommandations.

You may qualify if:

• women giving birth

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal swab

Study Officials

• Bruno POZZETTO, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 15, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 18, 2009

Record last verified: 2009-06

Locations

FR (1)