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Completed

NCT Number: NCT00920530

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: BBFAST

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 15, 2009
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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