Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 109
- Locations
- 26
- Primary Endpoint
- Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Cardiac activity present in the embryo
- •Hemoperitoin
- •Hemodynamic instability
- •Spontaneous pelvic pain
- •Contre indication to methotrexate
- •Protected adult patient
Arms & Interventions
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
Intervention: Therapeutic decision tool (Other)
Outcomes
Primary Outcomes
Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
Time Frame: 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.
Secondary Outcomes
- 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)