Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Rennes、法国、35033
- Rennes University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Minor
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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.
大体时间：6 months
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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.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Waiting time in emergency unit for patients
大体时间：6 months
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Waiting time in emergency unit for patients
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6 months
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Amount of blood tests avoided with the rapid pregnancy diagnostic test
大体时间：6 months
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Amount of blood tests avoided with the rapid pregnancy diagnostic test
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6 months
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合作者和调查者
调查人员
- 首席研究员：Vincent Lavoué, Pr、Rennes University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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