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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

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.

Condition or disease Intervention/treatment
Urinary Tract Infection in Pregnancy Urinary Tract Infection Following Delivery Catheter Infection Other: Catheter insertion

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
Estimated Enrollment : 638 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.
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.

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

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914144


Contacts
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Contact: Georgia Smith, MbChb 07855531946 georgiasmith@nhs.net
Contact: Mark James, MbChb 03004222222 mark.james@nhs.net

Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Mark James, MbChb Gloucestershire NHS Foundation Trust
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Responsible Party: Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03914144    
Other Study ID Numbers: 18/105/GHT
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gloucestershire Hospitals NHS Foundation Trust:
catether
pregnancy
postnatal infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Bacteriuria
Urologic Diseases