Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 26
- 主要终点
- Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
研究概览
简要总结
The aim's study is to validate a therapeutic aid in women with a less active ectopic pregnancy. A prospective recrutement of 100 women will be performed in 16 different hospitals in France. The decision aid will be used and a questionnaire about its usefulness, comprehension and satisfaction will be given to women and doctors.
详细描述
In less active ectopic pregnancy, two treatments are possible: a medical treatment using methotrexate or a surgical management.
A discret choice experiment study was performed to reveal women's preferences between these two options. In conclusion, calculated preferences are 47.5 and 52.5%, revealing a difficult choice for women. This study also lead to identify the main attributes important to make the choice. We were then able to create a therapeutic decision aid to help this shared decision.
This aid needs to be validated, following steps for validation. This study is the last step in women in situation of less active ectopic pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who speak and read french
- •Not opposed to participate to the research
- •With a tubal ectopic pregnancy visible at sonography
- •with an HCG rate under 10 000UI/ml
排除标准
- •Cardiac activity present in the embryo
- •Hemoperitoin
- •Hemodynamic instability
- •Spontaneous pelvic pain
- •Contre indication to methotrexate
- •Protected adult patient
研究组 & 干预措施
Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision
Women will have a therapeutic decision tool to help medical decision making and women and doctors will have to fill a questionnaire about the tool and the decision made
干预措施: Therapeutic decision tool (Other)
结局指标
主要结局
Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
时间窗: One day
Acceptability will be evaluated using a score from the Traditional Decisional Conflict Scale (DCS) translated in french. Women will fill it after the choice of the treatment and the realisation of it.
次要结局
- To evaluate satisfaction of women and of doctor in using the tool(One day)
- Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy.(One day)