Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
研究概览
简要总结
This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.
The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
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
- •Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
- •Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
- •Informed patients accepting the computer processing of their medical data and their right of access and correction.
排除标准
- •Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
- •Patients with contraindications to medical abortion.
- •Patients with severe and progressive disease.
- •Patients unable to complete a questionnaire.
- •Patients refusing to participate in the study.
结局指标
主要结局
concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
时间窗: At the follow-up at 2-3 weeks after inclusion
There was concordance if : * The result of urinary test is \< 1000 IU/L and the value of β-hCG blood measurement was \< 1000 IU/L, Or if * The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L. There was discrepancy if: * The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was \< 1000 IU/L, Or if * The result of urinary test is \< 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.
次要结局
- Acceptability of the urinary semi-quantitative test by the patient(at the follow up at 2-3 weeks after the inclusion)