search
Back to results

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

Primary Purpose

To Validate a Decision Aid for Ectopic Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic decision tool
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for To Validate a Decision Aid for Ectopic Pregnancy focused on measuring decision aid, shared decision making, less active ectopic pregnancy, methotrexate, medical treatment, surgery

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    To evaluate satisfaction of women and of doctor in using the tool
    A specific questionnaire using Likert scale will be used

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 23, 2023
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05745831
    Brief Title
    Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study
    Acronym
    GEUDECID
    Official Title
    Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    To Validate a Decision Aid for Ectopic Pregnancy
    Keywords
    decision aid, shared decision making, less active ectopic pregnancy, methotrexate, medical treatment, surgery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective mulicentric study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision
    Arm Type
    Experimental
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Therapeutic decision tool
    Intervention Description
    A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated
    Primary Outcome Measure Information:
    Title
    Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
    Description
    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.
    Time Frame
    One day
    Secondary Outcome Measure Information:
    Title
    Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy.
    Description
    The same Traditional Decisional Conflict Scale (DCS) will be used in gynecologist who will managed the women
    Time Frame
    One day
    Title
    To evaluate satisfaction of women and of doctor in using the tool
    Description
    A specific questionnaire using Likert scale will be used
    Time Frame
    One day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs