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

NCT03914144 | Withdrawn DMC

• 1 other identifier: 18/105/GHT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

catether; pregnancy; postnatal infection

Outcome Measures

Primary Outcomes (1)

• Postpartum Urinary Tract Infection

  Number 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.)

  30 days post delivery

Secondary Outcomes (1)

• Postpartum asymptomatic bacteriuria

  30 days post delivery

Study Arms (4)

Normal Vaginal Delivery

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.

Other: Catheter insertion

Insturmental Vaginal Delivery

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.

Other: Catheter insertion

Emergency Caesarean Section

Each patient will be recorded how many catheter episodes occurred during their labour and delivery.

Other: Catheter insertion

Elective Caesarean Section

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.

Other: Catheter insertion

Interventions

Catheter insertion OTHER

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.

Elective Caesarean Section; Emergency Caesarean Section; Insturmental Vaginal Delivery; Normal Vaginal Delivery

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Intact membranes
• At least 37 weeks pregnant

You may not qualify if:

• 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

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

Patients are asked to provide 3 samples of urine which are to be processed in the laboratory with routine testing for microscopy, culture and sensitivity and disposed of in the standard way.

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Mark James, MbChb

  Gloucestershire NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: May 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share