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

April 24, 2026 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

Completed

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 (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amilly, France, 45200
        • Service de gynécologie-obstétrique - Ch Montargis
      • Angers, France, ANGERS cedex 09
        • Service de Gynécologie-obstétrique - CHU Angers
      • Bron, France, 69677 Bron cedex
        • Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant
      • Caen, France, 14 033 Caen Cedex 09
        • Service de gynécologie-obstétrique - CHU Caen
      • Clermont-Ferrand, France, 63003 Clermont-Ferrand cedex
        • Service de Gynécologie-obstétrique - CHU Estaing
      • Le Kremlin-Bicêtre, France, 94275 Kremlin Bicêtre Cedex
        • Service Gynécologie - Hopital Bicêtre
      • Lille, France, 59000
        • Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert
      • Lille, France, 59307 Lille Cedex
        • Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre
      • Lyon, France, 69000
        • Service de gynécologie-obstétrique - Hopital Croix Rousse
      • Montpellier, France, 34295 Montpellier cedex 5
        • Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve
      • Nantes, France
        • Sevrice de gynécologie-obstétrique - CHU Nantes
      • Nîmes, France, 3000
        • Service de Gynécologie-obstétrique - CHU Nîmes -
      • Rennes, France
        • Service de gynécologie-obstétrique - CHU Rennes
      • Saint-Etienne, France, 42100
        • Service de gynécologie-obstétrique - CHU St Etienne
      • Tours, France, 37044 Tours Cedex 01
        • Service de gynécologie-obstétrique - CHU Tours bretonneau

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 22, 2023

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

April 22, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

June 1, 2024

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

product manufactured in and exported from the U.S.

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.

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