A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
研究概览
简要总结
Study Design:
Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Detailed Description
The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination.
Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.
详细描述
Outcomes:
Primary Outcome Measures:
• The duration of insertion between the Foley catheter groups with and without a stylette.
Secondary Outcome Measures:
• Pain assessed by visual analogue scale (VAS), in women randomly allocated to rigid stylette or no rigid stylette placement of a Foley catheter for induction of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Singleton fetus
- •Cephalic presentation
- •Indicated or Post-Estimated Date of Confinement
- •Induction of labor with a Bishop score < 5
排除标准
- •Low lying placenta
- •Undiagnosed vaginal bleeding
- •History of induction or pre-induction agent during the same pregnancy
- •Signs or symptoms of infection (i.e. Maternal fever)
- •Rupture of membranes
- •Multiple gestation
- •Women with an urgent or emergent clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
研究组 & 干预措施
Stylette
Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.
干预措施: Stylette (Device)
No Stylette
No Stylette: 22 French Foley catheter placed without stylette or guide.
结局指标
主要结局
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
时间窗: Followed throughout patient's hospital stay, approximately 10 days
Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).
次要结局
- Pain Assessed by Visual Analog Scale (VAS)(Followed throughout patient's hospital stay, approximately 10 days)