Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Negative predictive value of urine pregnancy test CHECK TOP
研究概览
简要总结
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.
The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.
The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.
In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.
To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.
The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.
This is a monocentric observational study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years of age
- •Undergoing drug abortion in Orthogenic Departement, Croix-Rousse Hospital, Lyon
- •Intrauterine pregnancy, single or multiple, until 8 weeks of amenorrhea
- •Agreeing to participate in the study after receiving information note
- •Affiliated to a social security system
- •Not subject to a measure of legal protection
排除标准
- •Women <18 years
- •Ineligible patient to drug abortion
- •Patient practicing a surgical abortion
结局指标
主要结局
Negative predictive value of urine pregnancy test CHECK TOP
时间窗: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Negative predictive value of urine pregnancy test CHECK TOP taking as reference transvaginal ultrasound. A negative result at transvaginal ultrasound will be defined as the absence of ongoing pregnancy. An ongoing pregnancy is characterized by the presence of gestational sac, yolk sac and/or embryo with cardiac activity. A positive result will be retained only in case of ongoing pregnancy. Check Top test will be considered as negative if only one colored line appears in the control window, without any line in the result window. It will be considered as positive if two colored lines are present in the result window, corresponding to a β-HCG level \> 1000 IU/ml.
次要结局
- Positive predictive value of urine pregnancy test Check Top(During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21))
- Sensibility of urine pregnancy test Check Top(During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21))
- Specificity of urine pregnancy test Check Top(During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21))
- Acceptability of urine pregnancy test Check Top by patients.(During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21))