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Completed

NCT Number: NCT01757041

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Bamba sub-District Hospital, Bamba, Coast, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted for delivery

Exclusion criteria

  • Consent refusal

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Wellcome Trust

Registry information

Official study title

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

Acronym: GBS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2012
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.