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Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03914144
Enrollment
0
Registered
2019-04-16
Start date
2019-05-01
Completion date
2019-08-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection in Pregnancy, Urinary Tract Infection Following Delivery, Catheter Infection

Keywords

catether, pregnancy, postnatal infection

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.

Interventions

A data collection sheet will be assigned for every patient who is recruited for the study. The clinician caring for the patient will be asked to fill in this form after the delivery has occurred. The form essentially will describe if the patient received any catheter during the delivery and if so, an indwelling catheter or an intermittent (in/out) catheter and how many episodes this occurred.

Sponsors

Gloucestershire Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

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

Design outcomes

Primary

MeasureTime frameDescription
Postpartum Urinary Tract Infection30 days post deliveryNumber of patients diagnosed with a postpartum urinary tract infection within 30 days of delivery. (This is defined as positive MSU (\>107 cfu/l) with associated symptoms.)

Secondary

MeasureTime frameDescription
Postpartum asymptomatic bacteriuria30 days post deliveryNumber of patients diagnosed with a postpartum asymptomatic bacteriuria detected within 30 days of delivery. (This is defined as positive MSU (\>107 cfu/l) without associated symptoms.)

Contacts

PRINCIPAL_INVESTIGATORMark James, MbChb

Gloucestershire NHS Foundation Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026