Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study

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.

Official Title
-----------------
Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy

Conditions
-----------------
To Validate a Decision Aid for Ectopic Pregnancy

Intervention / Treatment
-----------------
* Other: Therapeutic decision tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective mulicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision<br>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 | Other: Therapeutic decision tool<br>* A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy. | 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. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy. | The same Traditional Decisional Conflict Scale (DCS) will be used in gynecologist who will managed the women | One day | 
| To evaluate satisfaction of women and of doctor in using the tool | A specific questionnaire using Likert scale will be used | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate, decision aid, shared decision making, less active ectopic pregnancy, medical treatment, surgery