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NCT02339077 Clinical Trial

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

Stillbirth Clinical Trial

— Stillborn  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02339077
Other study ID # V98_27OBTP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date December 2015

Study information
Verified date September 2018
Source University of Witwatersrand, South Africa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 354
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Day
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
South Africa Chris Hani Baragwanath Academic Hospital Johannesburg Gauteng
South Africa Respiratory and Meningeal Pathogen Research Unit Johannesburg Gauteng

Sponsors (1)
Lead Sponsor Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs Birth
Secondary 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 Birth
Secondary 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 Birth
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