Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
Stillborn
1 other identifier
observational
354
1 country
2
Brief Summary
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 28, 2024
September 1, 2018
1 year
August 11, 2014
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
Birth
Secondary Outcomes (2)
Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)
Birth
Number of stillbirths related to a probable Infectious cause
Birth
Eligibility Criteria
Stillborn infants (gestational age \>= 28 weeks gestation) born at CHBAH
You may qualify if:
- 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)
You may not qualify if:
- Refuses to consent to study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Respiratory and Meningeal Pathogen Research Unit
Johannesburg, Gauteng, 2013, South Africa
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
Biospecimen
Cord blood Placenta skin swab from fetus Gastric/ tracheal aspirate
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 11, 2014
First Posted
January 15, 2015
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
May 28, 2024
Record last verified: 2018-09