GBS carriage in pregnant women - Part 2 of the Netherlands Observational study on Gbs disease, Bacterial virulence and protective Serology - (NO GBS)

GBS carriage in pregnant women - Part 2 of the Netherlands Observational study on Gbs disease, Bacterial virulence and protective Serology - (NO GBS) - GBS carriage in Dutch pregnant women

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52426

Enrollment

1500

Registered

2017-08-23

Start date

2019-09-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 meningitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women who plan to deliver in participating hospital.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
- Prevalence of GBS carriage in pregnant women in the Netherlands - Whole genome sequencing of colonizing GBS isolates with Illumina HiSeq at the Wellcome Trust Sanger Institute - Specific IgG concentrations by enzyme-linked immunosorbent assay (ELISA) and functionality against GBS vaccine targets in maternal serum from pregnant women colonized with GBS and non-carriers, and cord blood from their newborns	—

Measure

Time frame

- Prevalence of GBS carriage in pregnant women in the Netherlands - Whole genome sequencing of colonizing GBS isolates with Illumina HiSeq at the Wellcome Trust Sanger Institute - Specific IgG concentrations by enzyme-linked immunosorbent assay (ELISA) and functionality against GBS vaccine targets in maternal serum from pregnant women colonized with GBS and non-carriers, and cord blood from their newborns

—

Secondary

Measure	Time frame
- Comparison of specific IgG distributions and functionality against vaccine targets at delivery in pregnant women colonized with GBS and mothers of patients with invasive GBS disease - Comparison of specific IgG distributions and functionality against vaccine targets in newborns from pregnant women colonized with GBS (blood spots and cord blood) and patients with invasive GBS disease (blood spots and serum) - Genome wide association study comparing invasive to colonizing GBS isolates	—

Measure

Time frame

- Comparison of specific IgG distributions and functionality against vaccine targets at delivery in pregnant women colonized with GBS and mothers of patients with invasive GBS disease - Comparison of specific IgG distributions and functionality against vaccine targets in newborns from pregnant women colonized with GBS (blood spots and cord blood) and patients with invasive GBS disease (blood spots and serum) - Genome wide association study comparing invasive to colonizing GBS isolates

—

Countries

Netherlands

Contacts

Public ContactMW Bijlsma

Amsterdam UMC

nogbs@amsterdamumc.nl0205661564

Outcome results