Prematurity Clinical Trial
— COMPAreOfficial title:
Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
This study is designed to allow cord blood sample collection from the cords of babies born in three gestational age windows: ≥37 gestational weeks, 32-36+6 gestational weeks and less than 32 gestational weeks to investigate whether the result obtained using a standard hSBA assay is comparable to that achieved using complement from a gestation matched population for meningococcal B and pertussis.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | September 21, 2021 |
Est. primary completion date | September 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Pregnant and planning to deliver at St George's University Hospitals NHS Foundation Trust Exclusion Criteria: - Aged less than 16 years - Known complement deficiency |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's, University of London | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SBA assay results | Comparison of the SBA assay results obtained when using adult human complement compared with a gestationally matched complement source | Cord blood sampling will be performed at the time of delivery |
Status | Clinical Trial | Phase | |
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