GBS carriage in pregnant women - Part 2 of the Netherlands Observational study on Gbs disease, Bacterial virulence and protective Serology - (NO GBS)
Recruiting
- Conditions
- Streptococcus agalactiae or group B Streptococcus or GBS. Colonization of Carriage. Sepsis/severe bacterial bloodinfection. Bacterial infection of the membranes lining in the brain or meningitis100079511002892010004018
- Registration Number
- NL-OMON52426
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
Pregnant women who plan to deliver in participating hosptal.
Exclusion Criteria
Oral or intravenous antibiotic treatment in the month prior to the first GBS
colonization culture
In case the newborn develops culture positive invasive GBS disease in the first
90 days of life, the results will be excluded from the analysis of the carriage
study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Prevalence of GBS carriage in pregnant women in the Netherlands<br /><br>- Whole genome sequencing of colonizing GBS isolates with Illumina HiSeq at the<br /><br>Wellcome Trust Sanger Institute<br /><br>- Specific IgG concentrations by enzyme-linked immunosorbent assay (ELISA) and<br /><br>functionality against GBS vaccine targets in maternal serum from pregnant<br /><br>women colonized with GBS and non-carriers, and cord blood from their newborns</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Comparison of specific IgG distributions and functionality against vaccine<br /><br>targets at delivery in pregnant women colonized with GBS and mothers of<br /><br>patients with invasive GBS disease<br /><br>- Comparison of specific IgG distributions and functionality against vaccine<br /><br>targets in newborns from pregnant women colonized with GBS (blood spots and<br /><br>cord blood) and patients with invasive GBS disease (blood spots and serum)<br /><br>- Genome wide association study comparing invasive to colonizing GBS isolates</p><br>