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临床试验/NCT03914144
NCT03914144Unknown不适用

Postnatal Prevalence of Bacteriuria in Women With Catheter Versus no Catheter in Labour: a Prospective Cohort Study

Gloucestershire Hospitals NHS Foundation Trust0 个研究点目标入组 638 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
638
主要终点
Postpartum Urinary Tract Infection

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • • Participant is willing and able to give informed consent for participation in the study
  • Intact membranes
  • At least 37 weeks pregnant

排除标准

  • • 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

结局指标

主要结局

Postpartum Urinary Tract Infection

时间窗: 30 days post delivery

Postpartum urinary tract infection within 30 days of delivery, defined as positive MSU (\>107 cfu/l) with associated symptoms.

次要结局

  • Postpartum asymptomatic bacteriuria(30 days post delivery)

研究者

申办方类型
Other
责任方
Sponsor

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