Group B Streptococcus (GBS) ColonizationGBSNCT05469256
Group B Streptococcus Colonization in Mother-newborn Dyads and Association With Serotype-specific Capsular Antibodies in Karachi, Pakistan.
An observational study of Group B Streptococcus (GBS) Colonization, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants. Approximately two-thirds of invasive GBS disease occurs during the first three days of life of which 75%-90% occur within 24 hours of birth in the… Read more about this study
- Who is it for?
- Ages 13 to 49 years, women only
- Conditions the study is for
- Group B Streptococcus (GBS) Colonization
- How many people
- 600 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Apr 2019to 30 Dec 2019
- 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 13 to 49 years
- Women only
- Child, Adult
Study population: This study will be focused on pregnant women who are delivered at term (≥37 weeks of gestation age). The study will be limited to women delivering by normal vaginal delivery. Gestational age staging will be determined by extrapolation of the date of last menstrual period and corroborated by physical examination of mother and/or infant and/or ultrasound report if available.
Who may be able to join
- Pregnant women age 13-49 years age.
- Pregnant women ≥37 weeks' gestation.
- Delivering by normal vaginal delivery.
- Are able to provide informed consent.
Who cannot join
- Unwilling to consent to be on the study
- Women who had taken any antibiotic treatment in previous two weeks 3 .Women who have blood transfusion in 30 days before delivery.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
PHC at Ibrahim Haidry Goth, Ali Akber Shah Colony, Rerhi Goth, Bhains Colony
Karachi, Sindh
About this study
Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants. Approximately two-thirds of invasive GBS disease occurs during the first three days of life of which 75%-90% occur within 24 hours of birth in the absence of clinical interventions such as intrapartum antibiotic prophylaxis (IAP). Invasive GBS disease during the first week (Early onset disease, EOD) of life results from vertical acquisition of GBS in utero by the foetus or during labour from recto-vaginally colonized women. The incidence of EOD in full-term new-borns has declined by approximately 90% in countries where there is routine screening of pregnant women for GBS recto-vaginal colonization at 35-37 weeks of gestational age and where IAP is provided 4 hours prior to delivery to colonized women. The strategy for routine screening for GBS colonization coupled with IAP, however, is not logistically feasible in most resource-constrained countries including Pakistan and has also been shown to be not cost-effective including in some high-income countries. The current CDC recommendation for the isolation of GBS from vaginal and rectal or recto-vaginal swabs is by initial growth in a selective broth medium with antibiotics, followed by subculture on blood agar or selective media.
This study aims to address the knowledge gaps to better inform the epidemiology of GBS in a low income setting and address some of the critical limitations of current data from low-middle income countries. Women who had normal vaginal delivery at term (>37 weeks of gestation age) will be enrolled in this study. Recto-vaginal swabs from the mothers will be collected for GBS.
All samples will be collected by trained midwives/physician before delivery. All newborns born to these mothers will be followed at 28th day after birth to assess their health status with emphasis on possible invasive disease episodes.
- Conditions
- Group B Streptococcus (GBS) Colonization
- Medical subject headings
- Guillain-Barre Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of GBS colonization in pregnant women
- Define the prevalence of GBS colonization in pregnant women at term-delivery and vertical acquisition thereof by the new-born in low income settlements in Karachi, Pakistan.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start8 Apr 2019
- Primary completion30 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcus (GBS) ColonizationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Emory University
- Responsible party
- Principal investigator, Dr Fyezah Jehan, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469256
- Sponsor's protocol ID
- 302-667
- Acronym
- GBS
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group B Streptococcus Colonization in Mother-newborn Dyads and Association With Serotype-specific Capsular Antibodies in Karachi, Pakistan.
- ClinicalTrials.gov ID
- NCT05469256
- Acronym / sponsor ID
- GBS / 302-667
- Conditions
- Group B Streptococcus (GBS) Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Emory University
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Jul 2022 (actual)
- 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.
Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants. Approximately two-thirds of invasive GBS disease occurs during the first three days of life of which 75%-90% occur within 24 hours of birth in the absence of clinical interventions such as intrapartum antibiotic prophylaxis (IAP). Invasive GBS disease during the first week (Early onset disease, EOD) of life results from vertical acquisition of GBS in utero by the foetus or during labour from recto-vaginally colonized women. The incidence of EOD in full-term new-borns has declined by approximately 90% in countries where there is routine screening of pregnant women for GBS recto-vaginal colonization at 35-37 weeks of gestational age and where IAP is provided 4 hours prior to delivery to colonized women. The strategy for routine screening for GBS colonization coupled with IAP, however, is not logistically feasible in most resource-constrained countries including Pakistan and has also been shown to be not cost-effective including in some high-income countries. The current CDC recommendation for the isolation of GBS from vaginal and rectal or recto-vaginal swabs is by initial growth in a selective broth medium with antibiotics, followed by subculture on blood agar or selective media.
This study aims to address the knowledge gaps to better inform the epidemiology of GBS in a low income setting and address some of the critical limitations of current data from low-middle income countries. Women who had normal vaginal delivery at term (>37 weeks of gestation age) will be enrolled in this study. Recto-vaginal swabs from the mothers will be collected for GBS.
All samples will be collected by trained midwives/physician before delivery. All newborns born to these mothers will be followed at 28th day after birth to assess their health status with emphasis on possible invasive disease episodes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- This study will be focused on pregnant women who are delivered at term (≥37 weeks of gestation age). The study will be limited to women delivering by normal vaginal delivery. Gestational age staging will be determined by extrapolation of the date of last menstrual period and corroborated by physical examination of mother and/or infant and/or ultrasound report if available.
Key inclusion criteria (4 listed)
- Pregnant women age 13-49 years age.
- Pregnant women ≥37 weeks' gestation.
- Delivering by normal vaginal delivery.
- Are able to provide informed consent.
Key exclusion criteria (2 listed)
- Unwilling to consent to be on the study
- Women who had taken any antibiotic treatment in previous two weeks 3 .Women who have blood transfusion in 30 days before delivery.
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
Prevalence of GBS colonization in pregnant women
Time frame: 6-8 months
i) Define the prevalence of GBS colonization in pregnant women at term-delivery and vertical acquisition thereof by the new-born in low income settlements in Karachi, Pakistan.
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 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcus (GBS) Colonization, run by Aga Khan University at 1 site in Pakistan.
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 2 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Prevalence of GBS colonization in pregnant women (time frame: 6-8 months). 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 21 Jul 2022.