The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast (GBS)
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|ClinicalTrials.gov Identifier: NCT01757041|
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : December 19, 2014
Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide. Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal sepsis (EOS, in <7 days of life) in sSA. In other regions, maternal carriage is associated with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with important consequences for public health interventions.
Through investigation of maternal carriage and perinatal outcomes at three different sites: rural, semi-rural and urban, this study will provide a comprehensive description of the burden of GBS in coastal Kenya, informing public health policy and driving forward interventions. Risk factors for maternal colonisation and invasive neonatal disease will be assessed, including through retrospective immunological investigation of cord blood in neonates subsequently identified as having invasive GBS disease or other adverse perinatal outcomes, compared to those without.
GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis), and these isolates will be compared to existing archived neonatal isolates from investigation of neonatal sepsis in KDH (Kilifi District Hospital). This is important so that we know the prevalent sub-types causing neonatal disease in Kenya, those which are carried by mothers, and therefore whether maternal GBS carriage correlates with a high risk of perinatal disease. GBS vaccines in development are type-specific and this will inform their use in sSA.
Stillbirths will also be investigated, in individual cases, through additional detailed microbiological and other laboratory investigations to make an assessment of the contribution of GBS to stillbirths in Kenya.
|Condition or disease|
|Streptococcus Agalactiae (Streptococcus Group B)|
|Study Type :||Observational|
|Actual Enrollment :||7967 participants|
|Official Title:||The Clinical and Molecular Epidemiology of Streptococcus Agalactiae (Group B Streptococcus)Maternal Colonisation and Association With Adverse Perinatal Outcomes|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
- Maternal recto-vaginal GBS colonisation [ Time Frame: Single time point (at delivery) ]Prevalence of GBS recto-vaginal carriage in pregnant mothers in rural, semi-rural and urban sites.
- Stillbirths [ Time Frame: Single time point (at delivery) ]Association of stillbirth with Group B Streptococcus
- Neonatal GBS Colonisation [ Time Frame: Within 4h of delivery ]Prevalence of neonatal GBS colonization
- Preterm birth [ Time Frame: Single time point (at delivery) ]Determine association between GBS and preterm birth
- Low birth weight [ Time Frame: Single time point (at delivery) ]Association of GBS with low birth weight babies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757041
|Bamba sub-District Hospital|
|Bamba, Coast, Kenya|
|Ganze Health Facility|
|Ganze, Coast, Kenya|
|Kilifi District Hospital|
|Kilifi, Coast, Kenya|
|Coast Provincial General Hospital|
|Mombasa, Coast, Kenya|
|Principal Investigator:||Anna Seale, BMBCh||KEMRI-Wellcome Trust and University of Oxford|