Clinical Evaluation of the AmniSure ROM Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 383
- 试验地点
- 4
- 主要终点
- The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
研究概览
简要总结
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.
详细描述
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must be pregnant.
- •Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
- •Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
- •Subjects providing informed consent.
排除标准
- •Subjects who have placenta previa.
- •Subjects who have heavy vaginal bleeding.
- •Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.
结局指标
主要结局
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
时间窗: One time at time of enrollment
The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes.
次要结局
未报告次要终点