Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
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| ClinicalTrials.gov Identifier: NCT03914144 |
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Recruitment Status :
Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
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Sponsor:
Gloucestershire Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Gloucestershire Hospitals NHS Foundation Trust
| Tracking Information | |||||||||
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| First Submitted Date | April 11, 2019 | ||||||||
| First Posted Date | April 16, 2019 | ||||||||
| Last Update Posted Date | April 16, 2019 | ||||||||
| Estimated Study Start Date | May 1, 2019 | ||||||||
| Estimated Primary Completion Date | August 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Postpartum Urinary Tract Infection [ Time Frame: 30 days post delivery ] Postpartum urinary tract infection within 30 days of delivery, defined as positive MSU (>107 cfu/l) with associated symptoms.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Postpartum asymptomatic bacteriuria [ Time Frame: 30 days post delivery ] Postpartum asymptomatic bacteriuria detected within 30 days of delivery, defined as positive MSU (>107 cfu/l) without associated symptoms.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study | ||||||||
| Official Title | Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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.
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| 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. | ||||||||
| Condition |
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| 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
638 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 1, 2019 | ||||||||
| Estimated Primary Completion Date | August 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03914144 | ||||||||
| Other Study ID Numbers | 18/105/GHT | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Gloucestershire Hospitals NHS Foundation Trust | ||||||||
| Study Sponsor | Gloucestershire Hospitals NHS Foundation Trust | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Gloucestershire Hospitals NHS Foundation Trust | ||||||||
| Verification Date | April 2019 | ||||||||