StillbirthStillbornNCT02339077
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
An observational study of Stillbirth, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
Trial summary
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Stillbirth
- How many people
- 354 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Oct 2014to Dec 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Stillborn infants (gestational age >= 28 weeks gestation) born at CHBAH
Who may be able to join
- 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)
Who cannot join
- Refuses to consent to study participation
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Respiratory and Meningeal Pathogen Research Unit
Johannesburg, Gauteng, 2013
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng
About this study
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths
Read the 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.
- Conditions
- Stillbirth
- Keywords
- Group B Streptococcus, stillborn
- Medical subject headings
- Stillbirth
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
Measured: Birth
Secondary outcomes (2)
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
Measured: 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
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StillbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farzanah Laher, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339077
- Sponsor's protocol ID
- V98_27OBTP
- Acronym
- Stillborn
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2014
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
- ClinicalTrials.gov ID
- NCT02339077
- Acronym / sponsor ID
- Stillborn / V98_27OBTP
- Conditions
- Stillbirth
- Keywords
- Group B Streptococcus, stillborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Stillborn infants (gestational age >= 28 weeks gestation) born at CHBAH
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Refuses to consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
Time frame: Birth
2 secondary outcomes
Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)
Time frame: Birth
Number of stillbirths related to a probable Infectious cause
Time frame: Birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs (time frame: Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.