Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.
详细描述
The most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. The gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. But this assay need time and expect women to wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration.
The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. A little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women who are in genital activity
- •Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.
- •Lack of intrauterine gestational sac determined using endo-vaginal ultrasound
- •Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.
排除标准
- •Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test.
- •Patients included in an ovarian stimulation program for infertility
- •Ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound.
- •Patient objecting to participate in the study
- •Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
结局指标
主要结局
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
时间窗: 6 months
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
次要结局
- Waiting time in emergency unit for patients(6 months)
- Amount of blood tests avoided with the rapid pregnancy diagnostic test(6 months)