Streptococcus Agalactiae (Streptococcus Group B) Clinical Trial
— GBSOfficial title:
The Clinical and Molecular Epidemiology of Streptococcus Agalactiae (Group B Streptococcus)Maternal Colonisation and Association With Adverse Perinatal Outcomes
| Verified date | December 2014 |
| Source | University of Oxford |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Kenya: Ethical Review Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 7967 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Admitted for delivery Exclusion Criteria: - Consent refusal |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oxford | Wellcome Trust |
Kenya,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | Stillbirths | Association of stillbirth with Group B Streptococcus | Single time point (at delivery) | No |
| Secondary | Neonatal GBS Colonisation | Prevalence of neonatal GBS colonization | Within 4h of delivery | No |
| Secondary | Preterm birth | Determine association between GBS and preterm birth | Single time point (at delivery) | No |
| Secondary | Low birth weight | Association of GBS with low birth weight babies | Single time point (at delivery) | No |