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

University of Witwatersrand, South Africa354 enrolled

Overview

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

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

354

Conditions

Stillbirth

Eligibility

Sex: ALLMax age: 1 Day

Medical Language ↔ Plain English

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

Locations (2)

Respiratory and Meningeal Pathogen Research Unit

Johannesburg, Gauteng, South Africa

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa

Outcomes

Primary Outcomes

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

Time frame: Birth

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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