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: Recruiting

Administrative data

• NCT number: NCT02339077
• Other study ID #: V98_27OBTP
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2014
• Last updated: January 9, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: University of Witwatersrand, South Africa
• Contact: Shabir A Madhi, MD, PhD
• Phone: +27-11-9834283
• Email: shabirm[@]nicd.ac.za
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• 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: Recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stillbirth

Locations

Country	Name	City	State
South Africa	Chris Hani Baragwanath Academic Hospital	Johannesburg	Gauteng
South Africa	Respiratory and Meningeal Pathogen Research Unit	Soweto, 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	No
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	No
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	No