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

The Clinical and Molecular Epidemiology of Streptococcus Agalactiae (Group B Streptococcus)Maternal Colonisation and Association With Adverse Perinatal Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Streptococcus Agalactiae (Streptococcus Group B)

• Study Type: Observational
• Enrollment (Actual): 7967

Contacts and Locations

Study Locations

• Kenya
  • Coast
    • Bamba, Coast, Kenya
      • Bamba sub-District Hospital
    • Ganze, Coast, Kenya
      • Ganze Health Facility
    • Kilifi, Coast, Kenya
      • Kilifi District Hospital
    • Mombasa, Coast, Kenya
      • Coast Provincial General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

Inclusion Criteria:

• Admitted for delivery

Exclusion Criteria:

• Consent refusal

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal recto-vaginal GBS colonisation	Prevalence of GBS recto-vaginal carriage in pregnant mothers in rural, semi-rural and urban sites.	Single time point (at delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stillbirths	Association of stillbirth with Group B Streptococcus	Single time point (at delivery)
Neonatal GBS Colonisation	Prevalence of neonatal GBS colonization	Within 4h of delivery
Preterm birth	Determine association between GBS and preterm birth	Single time point (at delivery)
Low birth weight	Association of GBS with low birth weight babies	Single time point (at delivery)

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Wellcome Trust
• Investigators: Principal Investigator: Anna Seale, BMBCh, KEMRI-Wellcome Trust and University of Oxford

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 28, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Africa; Newborn; Maternal; Streptococcus agalactiae
• Other Study ID Numbers: B9RUHL0