Group B Steptococcus agalactiae infection Infections and Infestations
Conditions
Interventions
We will quantify GBS DNA in the placenta, fetal membranes, amniotic fluid, and fetal blood from ~1,800 women being delivered by pre-labour caesarean section and compare the proportion of GBS-positive
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
Female
Age
17 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients planned for caesarean delivery at the Rosie Hospital Cambridge, prior to the onset of labour or membrane rupture
Exclusion criteria
Exclusion criteria: 1. Unable to consent 2. Aged 16 years old and under 3. Antibiotic treatment within the preceding week 4. An infectious condition which could represent a hazard (e.g. high-risk carrier of viral hepatitis B)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Admission of the neonate for special or intensive care since delivery due to the main diagnosis of confirmed or suspected sepsis measured using electronic medical records at the time of hospital discharge following delivery 2. Presence of group B Streptococcus (GBS) in fresh intra-uterine tissue samples (placenta, placental membranes, amniotic fluid, umbilical cord blood) and rectal and vaginal swabs detected by culture following delivery. Using current practices, samples will be incubated in Todd-Hewitt broth supplemented with antibiotics to select for GBS. After culture, identification of GBS will be confirmed using matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) mass spectrometry. Antibiotic disc susceptibility testing will be performed according to EUCAST guidelines. The presence of GBS DNA will be identified using PCR-qPCR for the bacterial 16S rRNA gene on frozen samples of the placenta, fetal membranes, fetal blood and amniotic fluid. 3. Presence of inflammation in the placenta and umbilical cord will be determined in frozen samples obtained at the time of delivery. Pro-inflammatory cytokines (IL-6, IL-8, TNF-a and IL-1ß ) will be measured using the R&D Systems Ella Automated Immunoassay platform. The levels of inflammatory cytokines will be compared between cases where GBS was detected with GBS-negative controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neonate outcome: 1. Apgar score measured according to APGAR scoring system at 1,5 and 10 minutes after delivery. Data obtained from electronic medical records. 2. Hypoxic ischaemic encephalopathy, defined as any diagnosis of hypoxic-ischaemic encephalopathy prior to discharge. Data obtained from electronic medical records following discharge. 3. Any invasive or non-invasive ventilation that was required prior to discharge from the hospital. Data obtained from electronic medical records following discharge 4. Any use of inotropes prior to discharge from the hospital. Data obtained from electronic medical records following discharge. 5. Length of stay in neonatal intensive care unit or special care baby unit. Determined following discharge by reviewing electronic medical records. Maternal outcome: 1. Maternal post-delivery haemorrhage, defined as a blood loss greater than 500 ml during their Caesarean section. Data obtained from electronic medical records. 2. Infection (e.g. endometritis). Defined as a temperature > 38oC or clinically treated for infection following caesarean section, determined by review of electronic medical records following discharge 3. Positive microbiology cultures for GBS (urine, high vaginal swab, placenta) during or after pregnancy. Determined by review of electronic medical records following discharge from hospital. | — |
Countries
England, United Kingdom
Outcome results
None listed