Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03914144
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-04-11
Brief Title:
Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour a Prospective Cohort Study
Sponsor:
Gloucestershire Hospitals NHS Foundation Trust
Organization:
Gloucestershire Hospitals NHS Foundation Trust
Study Overview
Official Title:
Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour a Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Catheterisation is an accepted tool in intrapartum bladder care and indwelling catheters are used routinely before elective caesarean sections However urinary catheters are associated with an increased rate of urinary tract infections which can lead to complications including increased maternal morbidity and prolonged hospital stay A Cochrane Review 2014 concluded that there is insufficient evidence to assess the routine use of indwelling bladder catheters in women undergoing caesarean section The incidence and causation of catheter-associated infection in this population is unknown We propose to provide this data by comparing urine samples from pregnant women before and after their delivery and analysing this against observational catheter use during the delivery This will be vital in conducting future research into potential change in policy on routine catheterisation It will also be beneficial to patients as it could reduce the burden of catheterisation by reducing their chance of developing a UTI and by reducing the associated morbidity
Detailed Description:
Research Question
Is the intrapartum use of a catheter - either intermittent or indwelling - associated with an increased incidence of postnatal bacteriuria when compared with women who are not catheterised
Method
Pregnant women will be recruited at Gloucestershire Royal Hospital Maternity Department from 37 weeks gestation Once eligibility is met they will be asked to provide a mid-stream urine sample which will be tested for microscopy culture and sensitivity MCS They will be analysed according to their mode of delivery Their notes will be scrutinised to assess whether or not a catheter was sited during their labour Postnatally they will be asked to provide an MSU on day 3 and day 28 which will both be sent for MCS A comparative analysis between each MSU will be performed and correlated to whether intrapartum catheterisation was undertaken
Data Collection Analysis
The data collection phase will take approximately three months with data analysis and write-up estimated to take a further one-two months
Is the intrapartum use of a catheter - either intermittent or indwelling - associated with an increased incidence of postnatal bacteriuria when compared with women who are not catheterised
Method
Pregnant women will be recruited at Gloucestershire Royal Hospital Maternity Department from 37 weeks gestation Once eligibility is met they will be asked to provide a mid-stream urine sample which will be tested for microscopy culture and sensitivity MCS They will be analysed according to their mode of delivery Their notes will be scrutinised to assess whether or not a catheter was sited during their labour Postnatally they will be asked to provide an MSU on day 3 and day 28 which will both be sent for MCS A comparative analysis between each MSU will be performed and correlated to whether intrapartum catheterisation was undertaken
Data Collection Analysis
The data collection phase will take approximately three months with data analysis and write-up estimated to take a further one-two months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None