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Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study

Conditions
Urinary Tract Infection Following Delivery
Urinary Tract Infection in Pregnancy
Catheter Infection
Interventions
Other: Catheter insertion
Registration Number
NCT03914144
Lead Sponsor
Gloucestershire Hospitals NHS Foundation Trust
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 (MC\&S). 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 MC\&S. 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
638
Inclusion Criteria
  • • Participant is willing and able to give informed consent for participation in the study

    • Intact membranes
    • At least 37 weeks pregnant
Exclusion Criteria
  • • History of microbiologically-confirmed bacteriuria in preceding 28 days

    • Patients who are in active labour
    • Women who have had either urine-specific or broad-spectrum antibiotics within the last 28 days

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Emergency Caesarean SectionCatheter insertionEach patient will be recorded how many catheter episodes occurred during their labour and delivery.
Normal Vaginal DeliveryCatheter insertionThe group of patients who achieved a normal delivery will be retrospectively assessed as to whether they had any episode of catheter insertion during their delivery.
Insturmental Vaginal DeliveryCatheter insertionThe group of patients who underwent instrumental delivery (ventouse or forceps) will be retrospectively assessed as to whether they had any episode of catheter insertion during their delivery.
Elective Caesarean SectionCatheter insertionWe expect all patients in this group to have an indwelling catheter sited before their elective caesarean sections, however we will assess each patient individually to confirm whether they had a catheter for their delivery.
Primary Outcome Measures
NameTimeMethod
Postpartum Urinary Tract Infection30 days post delivery

Postpartum urinary tract infection within 30 days of delivery, defined as positive MSU (\>107 cfu/l) with associated symptoms.

Secondary Outcome Measures
NameTimeMethod
Postpartum asymptomatic bacteriuria30 days post delivery

Postpartum asymptomatic bacteriuria detected within 30 days of delivery, defined as positive MSU (\>107 cfu/l) without associated symptoms.

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