Caesarean Delivery With or Without an Indwelling Bladder Catheter
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The incidence of urinary tract infection (UTI).
研究概览
简要总结
The aim of this study is to compare the incidence of catheter associated culture-based urinary tract infection (UTI) after elective CD with or without preoperative placement of a urinary catheter.
详细描述
Protokol version 2_13092018 Scientific protocol Caesarean delivery with or without an indwelling bladder catheter. A randomised trial.
Background In 2015, approximately 20% of all pregnant women gave birth by caesarean delivery (CD) in Denmark.
Preoperative preparations for CD include the placement of an indwelling urinary catheter. The rationale behind the procedure is to decrease the risk of surgical injury to a distended bladder and to avoid postoperative urinary retention, but the scientific evidence of the benefit to these matters is not compelling(1). On the other hand, the placement of an indwelling urinary catheter poses a considerable risk of urinary tract infection (UTI) (2), besides the costs associated with delayed ambulation, prolonged hospital stay and catheter associated discomfort to the woman (3, 4) A Cochrane review (1) on indwelling bladder catheter versus no catheter inserted at CD, found that indwelling bladder catheterization was associated with longer time to first spontaneous voiding and more pain/discomfort due to catheterization and/or with first voiding. Furthermore, the women with an indwelling catheter had longer time to ambulation and longer hospital stay. None of the included studies (n=3) in the review reported on bladder injury nor the prespecified criteria for diagnosing UTI and thus no result on UTI as a primary outcome could be obtained. In addition, none of the randomized trials on CD with or without an indwelling bladder catheter were carried out in countries with peri-operative procedures and handling of patients similar to those in Europe.
In a prospective clinical study (5), there were no bladder injuries in 344 women undergoing elective CD without a catheter. UTI was significantly more prevalent in the catheterized group (6%) than in the non-catheterized group (0.58%), P<0.05). In retrospective studies on women undergoing CD with an indwelling catheter, the overall prevalence of bladder injuries is found to be around 0.3%(6, 7).
The aim of this study is to compare the incidence of catheter associated culture- based urinary tract infection (UTI) after elective CD with or without preoperative placement of a urinary catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective caesarean section.
排除标准
- •Antibiotic therapy during the last week before caesarean section
- •≥ 3 prior CDs.
- •Contractions or rupture of membranes.
研究组 & 干预措施
Without placement of a catheter
No placement of indwelling catheter prior to Caesarean section
干预措施: Without placement of indwelling catheter (Procedure)
With placement of a catheter
Placement of indwelling catheter prior to Caesarean section
干预措施: With placement of indwelling catheter (Procedure)
结局指标
主要结局
The incidence of urinary tract infection (UTI).
时间窗: 3 days
Urine culture (second day post partum) yielding ≥ 10\*5 CFU/ml (of one type of bacteria).
次要结局
- Time to ambulation(Up until 48 hours)
- Length of hospital stay(Up until 7 days)
- Intraoperative laceration of the bladder(7 days)
- The incidence of preoperative bacteria in urineculture(1 day)
- The incidence of UTI later than second day postpartum(30 days)
- Any need for catheterization due to postoperative urinary retention(24 hours)
- Postpartum blood loss >1000 mL.(4 hours)