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

G

Gloucestershire Hospitals NHS Foundation Trust

Status

Unknown

Conditions

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

Treatments

Other: Catheter insertion

Study type

Observational

Funder types

Other

Identifiers

NCT03914144
18/105/GHT

Details and patient eligibility

About

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.

Full 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.

Enrollment

638 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

638 participants in 4 patient groups

Normal Vaginal Delivery
Description:
The 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.
Treatment:
Other: Catheter insertion
Insturmental Vaginal Delivery
Description:
The 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.
Treatment:
Other: Catheter insertion
Emergency Caesarean Section
Description:
Each patient will be recorded how many catheter episodes occurred during their labour and delivery.
Treatment:
Other: Catheter insertion
Elective Caesarean Section
Description:
We 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.
Treatment:
Other: Catheter insertion

Trial contacts and locations

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Central trial contact

Georgia Smith, MbChb; Mark James, MbChb

Data sourced from clinicaltrials.gov

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