COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast (GBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01757041
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : December 19, 2014
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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)

Layout table for study information
Study Type : Observational
Actual Enrollment : 7967 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Stillbirths [ Time Frame: Single time point (at delivery) ]
    Association of stillbirth with Group B Streptococcus

  2. Neonatal GBS Colonisation [ Time Frame: Within 4h of delivery ]
    Prevalence of neonatal GBS colonization

  3. Preterm birth [ Time Frame: Single time point (at delivery) ]
    Determine association between GBS and preterm birth

  4. Low birth weight [ Time Frame: Single time point (at delivery) ]
    Association of GBS with low birth weight babies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mothers admitted for delivery to participating health centres (Kilifi District Hospital, Coast Provincial General Hospital, Bamba sub-District Hospital, Ganze Health Facility).

Inclusion Criteria:

  • Admitted for delivery

Exclusion Criteria:

  • Consent refusal

Information from the National Library of Medicine

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 identifier (NCT number): NCT01757041

Layout table for location information
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
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Layout table for investigator information
Principal Investigator: Anna Seale, BMBCh KEMRI-Wellcome Trust and University of Oxford
Layout table for additonal information
Responsible Party: University of Oxford Identifier: NCT01757041    
Other Study ID Numbers: B9RUHL0
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by University of Oxford:
Streptococcus agalactiae