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

February 23, 2023 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • 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
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
A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated

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.
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.
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.
Time Frame: One day
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
Time Frame: One day
A specific questionnaire using Likert scale will be used
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C22-51

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on To Validate a Decision Aid for Ectopic Pregnancy

  • Nan Shen
    Novartis
    Not yet recruiting
    Disease and Biomarker Profiling of Chinese Lupus Nephritis
    Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc | Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype | Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring

Clinical Trials on Therapeutic decision tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe