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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Streptococcus Agalactiae
Neonatal Infections

Study type

Observational

Funder types

Other

Identifiers

NCT00920530
0808073

Details and patient eligibility

About

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.

Enrollment

224 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

224 participants in 1 patient group

Real time PCR monitoring
Description:
Women giving birth at the St Etienne Teaching Hospital

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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