Accuracy of a rapid intrapartum test for maternal group B streptococcal colonisation and its potential to reduce antibiotic usage in mothers with risk factors
- Conditions
- Early onset group B streptococcus infection in the neonatePregnancy and Childbirth
- Registration Number
- ISRCTN74746075
- Lead Sponsor
- Queen Mary, University of London (QMUL)
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35027057/ (added 18/01/2022) 2022 Funder report results in https://pubmed.ncbi.nlm.nih.gov/35195519/ (added 24/02/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1625
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 (<37 weeks’ gestation), with intact membranes or rupture of membranes of any duration, whether suspected, diagnosed or established.
5. Maternal pyrexia (>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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 26/04/2018:<br> 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.<br><br> Previous primary outcome measure:<br> 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.<br>
- Secondary Outcome Measures
Name Time Method