Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
Completed
- Conditions
- Stillbirth
- Registration Number
- NCT02339077
- Lead Sponsor
- University of Witwatersrand, South Africa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs Birth
- Secondary Outcome Measures
Name Time Method Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors) Birth To determine the epidemiology of stillbirths, including identification of maternal risk-factors
Number of stillbirths related to a probable Infectious cause Birth To determine the proportion of stillbirths that are associated with common fetal in-utero infections including; Syphilis (Treponema pallidum), Klebsiella sp, E. Coli
Trial Locations
- Locations (2)
Chris Hani Baragwanath Academic Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Respiratory and Meningeal Pathogen Research Unit
🇿🇦Johannesburg, Gauteng, South Africa