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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
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gloucestershire Hospitals NHS Foundation Trust

Tracking Information
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
 (submitted: April 11, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 11, 2019)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
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
  • Urinary Tract Infection in Pregnancy
  • Urinary Tract Infection Following Delivery
  • Catheter Infection
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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: Catheter insertion
  • Emergency Caesarean Section
    Each patient will be recorded how many catheter episodes occurred during their labour and delivery.
    Intervention: 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.
    Intervention: Other: Catheter insertion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 11, 2019)
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:

  • • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Georgia Smith, MbChb 07855531946 georgiasmith@nhs.net
Contact: Mark James, MbChb 03004222222 mark.james@nhs.net
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Patient information will be kept confidentially and not shared as per the Data Protection Act 2018
Responsible Party Gloucestershire Hospitals NHS Foundation Trust
Study Sponsor Gloucestershire Hospitals NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Mark James, MbChb Gloucestershire NHS Foundation Trust
PRS Account Gloucestershire Hospitals NHS Foundation Trust
Verification Date April 2019