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

NCT ID: NCT02339077

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stillbirth

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Witwatersrand, South Africa

OTHER

Sponsor Role lead

Responsible Party

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Farzanah Laher

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Respiratory and Meningeal Pathogen Research Unit

Johannesburg, Gauteng, South Africa

Site Status

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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V98_27OBTP

Identifier Type: -

Identifier Source: org_study_id

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