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Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting

Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02339077
Acronym
Stillborn
Enrollment
354
Registered
2015-01-15
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2024-05-28

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

Conditions

Stillbirth

Keywords

Group B Streptococcus, stillborn

Brief summary

This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths

Detailed description

A prospective, descriptive study will be undertaken involving mothers who have a stillbirth at Chris Hani Baragwanath Academic Hospital (CHBAH), a secondary-tertiary care hospital, from 2014 up until 2016.

Interventions

None listed

Sponsors

University of Witwatersrand, South Africa
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No

Inclusion criteria

* Pregnant women delivering a stillbirth at CHBAH * Participants aged ≥18 years * Able to understand and comply with planned study procedures * Provides written informed consent (either generic ICF or V98\_28OBTP)

Exclusion criteria

* Refuses to consent to study participation

Design outcomes

Primary

MeasureTime frame
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabsBirth

Secondary

MeasureTime frameDescription
Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)BirthTo determine the epidemiology of stillbirths, including identification of maternal risk-factors
Number of stillbirths related to a probable Infectious causeBirthTo determine the proportion of stillbirths that are associated with common fetal in-utero infections including; Syphilis (Treponema pallidum), Klebsiella sp, E. Coli

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026