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Maternal Group B Streptococcus identification study

Molecular detection of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women: a study of a novel diagnostic test

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN37848792
Enrollment
200
Registered
2022-11-02
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-01-28

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

Conditions

Group B Streptococcus agalactiae in pregnant women Pregnancy and Childbirth

Interventions

Women will be recruited from clinical areas which often require speculum examinations and swabs taken as part of the routine assessment in the Rosie Hospital, Cambridge (e.g. the Maternity Assessment

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
University of Cambridge
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Attending the Rosie Hospital, Cambridge, pregnant at any gestation, for an assessment which includes a vaginal examination and swabs taken 2. Aged 16 years old and over, and have the capacity to provide informed consent for themselves

Exclusion criteria

Exclusion criteria: Not meeting the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Presence of Group B Streptococcus (GBS) in the maternal genital tract (positive/ negative) at the time of a clinically-indicated vaginal swab at any point in pregnancy, measured with the following methodologies: 1.Routine microbiological culture and sensitivity without enriched media 2.Enriched microbiological culture specific for GBS 3.DNA extraction for multiplex PCR, with two approaches: 3.1.qPCR for sip, a GBS-specific gene of which GBS has only one copy 3.2.Nested PCR-qPCR for a GBS-specific sequence of the 16S RNA gene, of which the genome has seven copies

Secondary

MeasureTime frame
Maternal and neonatal outcomes measured by examination of electronic medical records at the time of hospital discharge following delivery: 1. Mode of delivery 2. Complications with labour/delivery (e.g. fever, chorioamnionitis, intensive care admission) 3. Gestation at delivery (days) 4. Birthweight (kg) 5. Admission to the NICU (and indication for admission) 6. Stillbirth/neonatal death

Countries

England, United Kingdom

Contacts

Public ContactEleanor Richards
paoandghod@medschl.cam.ac.uk+44(0)1223 336871

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026