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

January 9, 2015 updated by: Michelle Groome, University of Witwatersrand, South Africa
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Recruiting
        • Chris Hani Baragwanath Academic hospital
        • Contact:
      • Soweto, Johannesburg, Gauteng, South Africa, 2013
        • Recruiting
        • Respiratory and Meningeal Pathogen Research Unit
        • Contact:
        • Principal Investigator:
          • Shabir A Madhi, PhD
        • Sub-Investigator:
          • Clare L Cutland, MBBCH
        • Sub-Investigator:
          • Carmen Briner, MBBCH
        • Sub-Investigator:
          • Stephanie Jones, MBBCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
Time Frame: Birth
Birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)
Time Frame: Birth
To determine the epidemiology of stillbirths, including identification of maternal risk-factors
Birth
Number of stillbirths related to a probable Infectious cause
Time Frame: Birth
To determine the proportion of stillbirths that are associated with common fetal in-utero infections including; Syphilis (Treponema pallidum), Klebsiella sp, E. Coli
Birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witwatersrand, South Africa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (ESTIMATE)

January 15, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V98_27OBTP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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