Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
NCT ID: NCT03914144
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
638 participants
OBSERVATIONAL
2019-05-01
2019-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Emergency Caesarean Section
Each patient will be recorded how many catheter episodes occurred during their labour and delivery.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Intact membranes
* At least 37 weeks pregnant
Exclusion Criteria
* Patients who are in active labour
* Women who have had either urine-specific or broad-spectrum antibiotics within the last 28 days
FEMALE
No
Sponsors
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Gloucestershire Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Mark James, MbChb
Role: PRINCIPAL_INVESTIGATOR
Gloucestershire NHS Foundation Trust
Central Contacts
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Other Identifiers
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18/105/GHT
Identifier Type: -
Identifier Source: org_study_id
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