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

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01757041
First received: November 28, 2012
Last updated: December 18, 2014
Last verified: December 2014
  Purpose

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
Streptococcus Agalactiae (Streptococcus Group B)

Study Type: Observational
Study Design: 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

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Maternal recto-vaginal GBS colonisation [ Time Frame: Single time point (at delivery) ] [ Designated as safety issue: No ]
    Prevalence of GBS recto-vaginal carriage in pregnant mothers in rural, semi-rural and urban sites.


Secondary Outcome Measures:
  • Stillbirths [ Time Frame: Single time point (at delivery) ] [ Designated as safety issue: No ]
    Association of stillbirth with Group B Streptococcus

  • Neonatal GBS Colonisation [ Time Frame: Within 4h of delivery ] [ Designated as safety issue: No ]
    Prevalence of neonatal GBS colonization

  • Preterm birth [ Time Frame: Single time point (at delivery) ] [ Designated as safety issue: No ]
    Determine association between GBS and preterm birth

  • Low birth weight [ Time Frame: Single time point (at delivery) ] [ Designated as safety issue: No ]
    Association of GBS with low birth weight babies


Enrollment: 7967
Study Start Date: September 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders 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).
Criteria

Inclusion Criteria:

  • Admitted for delivery

Exclusion Criteria:

  • Consent refusal
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757041

Locations
Kenya
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
Investigators
Principal Investigator: Anna Seale, BMBCh KEMRI-Wellcome Trust and University of Oxford
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01757041     History of Changes
Other Study ID Numbers: B9RUHL0 
Study First Received: November 28, 2012
Last Updated: December 18, 2014
Health Authority: Kenya: Ethical Review Committee

Keywords provided by University of Oxford:
Streptococcus agalactiae
Maternal
Newborn
Africa

ClinicalTrials.gov processed this record on August 23, 2016