Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.
The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any adult patient presenting to the gynecological emergency department of the Paule de Viguier Hospital in Toulouse for whom a diagnosis of an arrested pregnancy in the first trimester is made
- •Whose cranio-caudal length of the embryo measured by ultrasound is less than 25 mm or having a clear egg
- •Having agreed to the study (written or verbal) after clear and fair information
- •Who understands and reads French
排除标准
- •Medical contraindication to treatment with Mifégyne® or MisoOne®
- •Hemodynamically unstable patient requiring urgent surgical treatment.
- •Protected adult patient (guardianship, curatorship, safeguard of justice)
研究组 & 干预措施
Medical treatment
Patients choosing medical treatment with Mifégyne® and MisoOne®
干预措施: Medical treatment with Mifégyne® and MisoOne® (Drug)
Surgical treatment
Patients choosing surgical treatment by endo-uterine aspiration.
干预措施: Endo-uterine aspiration (Procedure)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Inclusion day (day 0)
Patient satisfaction
时间窗: Inclusion day (day 0)
Completing the satisfaction questionnaire
次要结局
未报告次要终点