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

Catheter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03914144
• Other study ID #: 18/105/GHT
• Status: Not yet recruiting
• Start date: May 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2019
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: Georgia Smith, MbChb
• Phone: 07855531946
• Email: georgiasmith[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 638
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria
• Catheter Infection
• Communicable Diseases
• Infection
• Urinary Tract Infection Following Delivery
• Urinary Tract Infection in Pregnancy
• Urinary Tract Infections

Intervention

Other:
• Catheter insertion
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum Urinary Tract Infection	Postpartum urinary tract infection within 30 days of delivery, defined as positive MSU (>107 cfu/l) with associated symptoms.	30 days post delivery
Secondary	Postpartum asymptomatic bacteriuria	Postpartum asymptomatic bacteriuria detected within 30 days of delivery, defined as positive MSU (>107 cfu/l) without associated symptoms.	30 days post delivery