Clinical trial NCT03914144: Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
Official title: Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infection in Pregnancy
Urinary Tract Infection Following Delivery
Catheter Infection
Keywords: catether
pregnancy
postnatal infection
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 638
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target of recruitment is pregnant women from 37 weeks gestation. They will be recruited from the Maternity Triage Department, Antenatal Clinic, Central Delivery Suite, Birth Unit or the Maternity Ward.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum Urinary Tract Infection
timeFrame: 30 days post delivery
Secondary outcomes:
measure: Postpartum asymptomatic bacteriuria
timeFrame: 30 days post delivery
Other outcomes:
Locations:
Study officials:
affiliation: Gloucestershire NHS Foundation Trust
name: Mark James, MbChb
role: PRINCIPAL_INVESTIGATOR
References: