Early onset group B streptococcus infection in the neonate Pregnancy and Childbirth
Conditions
Interventions
We will identify around 1,340 mothers in labour who have risk factors for GBS infection in their newborn babies in at least 16 hospitals in the West Midlands and London during a 4-6 week study period.
Sponsors
Queen Mary, University of London (QMUL)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/04/2018: Presence of one or more of the following risk factors will define inclusion of the mother and baby into the study: 1. Previous baby with early or late onset neonatal GBS disease as reported by the mother and documented in the maternal notes. 2. GBS bacteriuria during current pregnancy, as documented in the maternal notes, irrelevant of whether the GBS bacteriuria was treated at the time of diagnosis with antibiotics. 3. GBS colonisation of the vagina and/or rectum (determined from a vaginal/rectal swab) in current pregnancy, as documented in the maternal notes. 4. Preterm labour (38°C) observed at any point in labour, including clinically suspected/confirmed chorioamnionitis Previous inclusion criteria: Presence of one or more of the following risk factors will define inclusion of the mother and baby into the study: 1. The mother has delivered a previous baby who developed neonatal GBS disease (early or later onset), as reported by the mother and documented in the maternal notes 2. GBS bacteriuria during the current pregnancy, as documented in the maternal notes, irrelevant of whether the GBS bacteriuria was treated at the time of diagnosis with antibiotics 3. GBS colonisation of the vagina and/or the rectum (determined from a recto/vaginal swab) in current pregnancy, as documented in the maternal notes 4. Maternal pyrexia (>38°C) observed at any point in labour, or clinically suspected/confirmed chorioamnionitis 5. Preterm labour with prelabour rupture of membranes of any duration 6. Preterm labour if there is suspected or confirmed intrapartum rupture of membranes lasting more than 18 hours
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 01/05/2018: Those who do not have any of the risk factors associated with an increased risk of being colonised by GBS Previous participant exclusion criteria as of 26/04/2018: 1. Aged under 16 years 2. Women in labour at a gestation age of <24 weeks 3. Women who, on arrival at the maternity unit, are already in second stage labour or who are likely to deliver their baby imminently 4. Women whose baby is known to have died in utero or who has a congenital anomaly incompatible with survival at birth 5. Women having an elective Caesarean delivery, which will be performed even if presenting in labour Previous participant exclusion criteria: Those who do not present with any of the risk factors associated with an increased risk of being colonised by GBS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 26/04/2018: The primary outcome measure for the randomised controlled trial part of the study is the proportion of women receiving IAP for GBS prophylaxis, of all those identified with one or more risk factors for GBS transmission. This is defined as those women receiving IAP which has been indicated for GBS prophylaxis (regardless of whether there is another reason for antibiotic administration), as a proportion of those identified by the delivery suite midwives as having one or more risk factors for GBS transmission. Previous primary outcome measure: To evaluate if rapid intrapartum GBS testing reduces maternal and neonatal antibiotic usage, compared with usual care where Intrapartum Antibiotic Prophylaxis (IAP) is directed based on maternal risk factors alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures for the randomised controlled trial part of the study as of 01/05/2018: 1. Intrapartum maternal antibiotic use for any indication, defined as those women receiving IAP for GBS prophylaxis, for a maternal clinical indication such as pyrexia, on maternal request, prior to caesarean section or any other reason as identified by delivery suite midwives as having one or more risk factors for GBS transmission. 2. Intrapartum maternal antibiotic use for any indication other than caesarean section, defined as women receiving intrapartum antibiotic for GBS prophylaxis, for a maternal clinical indication such as pyrexia, on maternal request, or for any other reason other than for caesarean section as identified by delivery suite midwives as having one or more risk factors for GBS transmission. 3. Neonatal antibiotic use for prophylaxis or treatment, defined as babies receiving antibiotic prophylaxis due to maternal GBS status or antibiotic treatment for suspected or confirmed neonatal infection as identified by delivery suite midwives as having one or more risk factors for GBS transmission. 4. Post-partum maternal antibiotics use for any indication, defined as those women receiving post-partum antibiotic which has been indicated as being a maternal clinical indication such as pyrexia, on maternal request, or for any other reason, as identified by the delivery suite midwives as having one or more risk factors for GBS transmission. The period where this data will be collected is from delivery until the mother’s discharge from either delivery hospital or from any hospital where they were immediately transferred. Antibiotic use data following any re-admittance or prescribed from a general practitioner will not be used. 5. Time of IAP exposure, defined as the duration between the start time of the first dose of IAP and the delivery of the baby. Sufficient exposure will | — |
Countries
England, United Kingdom
Contacts
Public ContactEmily Dixon
Outcome results
None listed