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

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

Completed

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Key information

Conditions

Stillbirth Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Chris Hani Baragwanath Academic Hospital, Johannesburg, Gauteng, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Time frame: Birth

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

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Registry information

Acronym: Stillborn

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 15, 2015
Registry last updated: May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed