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

NCT ID: NCT00920530

Last Updated: 2009-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Neonatal Infections Streptococcus Agalactiae

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Real time PCR monitoring

Women giving birth at the St Etienne Teaching Hospital

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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CHU SAINT ETIENNE

Principal Investigators

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Bruno POZZETTO, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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0808073

Identifier Type: -

Identifier Source: org_study_id

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