To Validate a Decision Aid for Ectopic Pregnancy
Conditions
Keywords
decision aid, shared decision making, less active ectopic pregnancy, methotrexate, medical treatment, surgery
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.
Interventions
OTHERTherapeutic decision tool
A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective mulicentric study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy. | 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
| Measure | Time frame | Description |
|---|---|---|
| Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy. | One day | The same Traditional Decisional Conflict Scale (DCS) will be used in gynecologist who will managed the women |
| To evaluate satisfaction of women and of doctor in using the tool | One day | A specific questionnaire using Likert scale will be used |
Countries
France
Outcome results
None listed