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CompletedNCT02339077StillbornUpdated May 28, 2024

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

An observational study in Stillbirth, sponsored by University of Witwatersrand, South Africa. Completed at 2 sites in South Africa. Open to participants aged Up to 1 Day. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by University of Witwatersrand, South Africa · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
354
Ages
Up to 1 Day
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Stillbirth

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Keywords

  • Group B Streptococcus, stillborn
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In context

Stillbirth

121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.

This study's enrollment of 354 is below the median of 794 across 52 observational studies indexed under Stillbirth.

Browse Stillbirth studies →

Lead sponsor

University of Witwatersrand, South Africa is the lead sponsor of 47 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Day
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stillborn infants (gestational age >= 28 weeks gestation) born at CHBAH

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refuses to consent to study participation
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
354 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs

    Time frame: Birth

Secondary outcomes

  1. Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)

    To determine the epidemiology of stillbirths, including identification of maternal risk-factors

    Time frame: Birth

  2. Number of stillbirths related to a probable Infectious cause

    To determine the proportion of stillbirths that are associated with common fetal in-utero infections including; Syphilis (Treponema pallidum), Klebsiella sp, E. Coli

    Time frame: Birth

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Study locations

2 sites
  • Respiratory and Meningeal Pathogen Research Unit
    Johannesburg, Gauteng 2013, South Africa
  • Chris Hani Baragwanath Academic Hospital
    Johannesburg, Gauteng, South Africa
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02339077
Lead sponsor
University of Witwatersrand, South Africa
Responsible party
Farzanah Laher (Dr, University of Witwatersrand, South Africa) — Principal investigator
First posted
Jan 15, 2015
Start date
Oct 2014
Primary completion
Oct 2015
Completion
Dec 2015
Last update
May 28, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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