Invasive infant disease caused by Group B Streptococcus Infections and Infestations
Conditions
Interventions
The trialists will establish maternal delivery/infant cord serum collection from 5 maternity units (around 4000 women) and test the feasibility of their strategies. They will collect a small sample of
Sponsors
St George's University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant 2. = 18 years of age 3. Delivering at one of the selected hospitals 4. Consented to participate during the study period
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of collecting serum at delivery (either maternal or cord or both) from a large cohort of pregnant women, assessed using: 1. Enrolment rate (the rate (proportion) of eligible women who are willing to participate in the delivery blood collection study) 2. Maternal and/or cord blood collection rate 3. Key clinical exclusion data (gestation at birth, receipt of IAP in labour (yes/no), type of IAP (list), time between administration of IAP and delivery (in hours) collection rate) 4. Infant iGBS surveillance consent rate | — |
Secondary
| Measure | Time frame |
|---|---|
| In the sub-study the following are assessed at delivery: 1. Rectovaginal swab study consent rate 2. Rectovaginal swab collection rate 3. Rectovaginal GBS colonisation rate 4. Rectovaginal GBS CPS serotype-specific colonisation rates In the sub-study where samples of maternal/cord blood and rectovaginal swabs are available, the following are assessed at delivery: 1. Infant blood sample study consent rate 2. Infant Guthrie card consent rate 3. Infant Guthrie card collection rate | — |
Countries
England, United Kingdom
Outcome results
None listed