Group B Streptococcus (GBS) Associated Stillbirths in a H... | NCT02339077

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

NCT02339077

Sponsor

University of Witwatersrand, South Africa

Status

Completed

Last Update Posted

May 28, 2024Actual

Enrollment

354Actual

Phase

Not provided

Conditions

Stillbirth

Interventions

Not provided

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Jan 9, 2015

First Posted Date

Jan 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2024

Last Update Posted Date

May 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Farzanah Laher, Dr, University of Witwatersrand, South AfricaPrincipal Investigator

Lead Sponsor

University of Witwatersrand, South AfricaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

354Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Number of stillbirths related to a probable Infectious cause

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Day

Standard Ages

Child

Study Population

Stillborn infants (gestational age >= 28 weeks gestation) born at CHBAH

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Respiratory and Meningeal Pathogen Research Unit		Johannesburg	Gauteng	2013	South Africa
Chris Hani Baragwanath Academic Hospital

Condition Browse Module

MeSH Terms

ID	Term
D050497	Stillbirth

Ancestor Terms

ID	Term
D005313	Fetal Death
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided