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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.
 
ClinicalTrials.gov Identifier: NCT01757041
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date November 28, 2012
First Posted Date December 28, 2012
Last Update Posted Date December 19, 2014
Study Start Date September 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast
Official Title The Clinical and Molecular Epidemiology of Streptococcus Agalactiae (Group B Streptococcus)Maternal Colonisation and Association With Adverse Perinatal Outcomes
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Streptococcus Agalactiae (Streptococcus Group B)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 18, 2014)
7967
Original Estimated Enrollment
 (submitted: December 20, 2012)
8000
Actual Study Completion Date October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Admitted for delivery

Exclusion Criteria:

  • Consent refusal
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kenya
Removed Location Countries  
 
Administrative Information
NCT Number NCT01757041
Other Study ID Numbers B9RUHL0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Wellcome Trust
Investigators
Principal Investigator: Anna Seale, BMBCh KEMRI-Wellcome Trust and University of Oxford
PRS Account University of Oxford
Verification Date December 2014