Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Presence / absence of stains comparing to a known color index printed on the product
研究概览
简要总结
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
详细描述
Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Pregnant women age 18 years and older attending delivery room.
- •Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
- •Able and willing to read and sign an informed consent document.
排除标准
- •Subjects will be excluded from the study if any of the following will be present:
- •Prior use of any amniotic fluid detection test.
- •Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
- •Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
- •Sexual intercourse within the past 24 hours.
- •Confirmed diagnosis of any vaginal infection within the past 7 days.
- •Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
- •Patients unable or unwilling to participate.
- •Patients in active labor (or with regular contractions).
结局指标
主要结局
Presence / absence of stains comparing to a known color index printed on the product
时间窗: 12 hours
Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.
次要结局
- Presence / absence of stains comparing to a known color index printed on the product(12 hours)