BHSB and Pseudomonas aeruginosa colonisation in pregnant women.
Research type
Research Study
Full title
Determination of Group B – B-haemolytic streptococcus and Pseudomonas aeruginosa vaginal colonisation in pregnant women by enrichment culture.
IRAS ID
158521
Contact name
E S R Darley
Contact email
Sponsor organisation
North Bristol NHS Trust
Clinicaltrials.gov Identifier
SF 109, Showering Fund reference number:
Research summary
The study proposed will combine two areas of overlapping research .
Part l. Background.
The first part of the study is part of routine lab work and does not require ethical approval. {The study will compare 2 nationally recognised methods of testing swabs for presence of Group B streptococcus and compare whether the enrichment method is better than our existing method of testing for BHSB.)
Part2.Ethics review relates to this part only.
Pseudomonas aeruginosa (PSAE) is an ubiquitous organism which can colonise vaginal mucosa however it’s significance is doubtful. PSAE is not sought nor
reported on when cultured in vaginal swabs. ln recent years neonatal infection with PSAE have focussed attention to the potential virulence of this organism for neonates and also questioned the bioburden of PSAE in hospital water as
this is assumed to be the most likely source of PSAE in NICU babies .
However, we know from experience at NBT and other neonatal units, that when babies acquire PSAE infection the strain which they have is rarely the same as any PSAE in samples cultured from the water. This suggests that babies could acquire PSAE from other sources, and potentially at delivery.
To identify rate of vaginal PSAE colonisation in pregnant women, all vaginal swabs routinely
submitted to medical microbiology will, be further cultured to detect or exclude presence of PSAE. As it is not standard protocol to report presence of pseudomonas from vaginal swabs, swabs processed in this part of the study will be anonymised and resulted reported by a generated number with no identifying details attached, and for review by investigators only.
The study will run for approximately 6-12 months , to attain results from
1000 individual HVS/LVS specimens. There are no clinical implications for patients in this study –clinicians will not be issued with any new or different information on the laboratory reports.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1156
Date of REC Opinion
15 Sep 2014
REC opinion
Favourable Opinion