Urinary Tract Infection in PregnancyNCT03914144
Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour
An observational study of Urinary Tract Infection in Pregnancy and Urinary Tract Infection Following Delivery, run by Gloucestershire Hospitals NHS Foundation Trust.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Tract Infection in Pregnancy, Urinary Tract Infection Following Delivery, Catheter Infection
- What is being tested?
- Catheter insertion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- • Participant is willing and able to give informed consent for participation in the study
- Intact membranes
- At least 37 weeks pregnant
Who cannot join
- • 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
About this study
Official title: Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Urinary Tract Infection in Pregnancy, Urinary Tract Infection Following Delivery, Catheter Infection
- Being tested
- Catheter insertion
- Keywords
- catether, pregnancy, postnatal infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter insertionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Catheter insertion | |
| Emergency Caesarean Section | Each patient will be recorded how many catheter episodes occurred during their labour and delivery. Receives: 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. Receives: Other: Catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 30 days post delivery
Secondary outcomes (1)
Postpartum asymptomatic bacteriuria
Number 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.)
Measured: 30 days post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Why it stopped: Study did not progress to approval process, and did not open.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark James, MbChb, Principal investigator, Gloucestershire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914144
- Sponsor's protocol ID
- 18/105/GHT
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information will be kept confidentially and not shared as per the Data Protection Act 2018
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03914144
- Acronym / sponsor ID
- 18/105/GHT
- Conditions
- Urinary Tract Infection in Pregnancy, Urinary Tract Infection Following Delivery, Catheter Infection
- Keywords
- catether, pregnancy, postnatal infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not progress to approval process, and did not open.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Vaginal Delivery | – | Other: Catheter insertionThe 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. |
| Insturmental Vaginal Delivery | – | Other: Catheter insertionThe 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. |
| Emergency Caesarean Section | – | Other: Catheter insertionEach patient will be recorded how many catheter episodes occurred during their labour and delivery. |
| Elective Caesarean Section | – | Other: Catheter insertionWe 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- • Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (3 listed)
- • History of microbiologically-confirmed bacteriuria in preceding 28 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter insertionA 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. | Other | Elective Caesarean Section, Emergency Caesarean Section, Insturmental Vaginal Delivery, Normal Vaginal Delivery |
Primary outcome
Postpartum Urinary Tract Infection
Time frame: 30 days post delivery
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.)
1 secondary outcome
Postpartum asymptomatic bacteriuria
Time frame: 30 days post delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Patient information will be kept confidentially and not shared as per the Data Protection Act 2018
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark James, MbChb principal investigator
Gloucestershire NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection in Pregnancy and Urinary Tract Infection Following Delivery, run by Gloucestershire Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Urinary Tract Infection (time frame: 30 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.