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

NCT ID: NCT05745831

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-22

Study Completion Date

2024-05-22

Brief Summary

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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

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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.

Conditions

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To Validate a Decision Aid for Ectopic Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective mulicentric study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Therapeutic decision tool

Intervention Type OTHER

A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated

Interventions

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Therapeutic decision tool

A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de gynécologie-obstétrique - Ch Montargis

Amilly, , France

Site Status

Service de Gynécologie-obstétrique - CHU Angers

Angers, , France

Site Status

Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant

Bron, , France

Site Status

Service de gynécologie-obstétrique - CHU Caen

Caen, , France

Site Status

Service de Gynécologie-obstétrique - CHU Estaing

Clermont-Ferrand, , France

Site Status

Service Gynécologie - Hopital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert

Lille, , France

Site Status

Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre

Lille, , France

Site Status

Service de gynécologie-obstétrique - Hopital Croix Rousse

Lyon, , France

Site Status

Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve

Montpellier, , France

Site Status

Sevrice de gynécologie-obstétrique - CHU Nantes

Nantes, , France

Site Status

Service de Gynécologie-obstétrique - CHU Nîmes -

Nîmes, , France

Site Status

Service de gynécologie-obstétrique - CHU Rennes

Rennes, , France

Site Status

Service de gynécologie-obstétrique - CHU St Etienne

Saint-Etienne, , France

Site Status

Service de gynécologie-obstétrique - CHU Tours bretonneau

Tours, , France

Site Status

Countries

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France

References

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Capmas P, Panjo H, Artignan J, Babelhadj A, Benoist I, Decouzon J, Jarrige C, Leglise M, Renoncet V, Pelletier-Fleury N. Women's preferences for less active ectopic pregnancy treatment: A discrete choice experiment. Eur J Obstet Gynecol Reprod Biol. 2024 Jan;292:175-181. doi: 10.1016/j.ejogrb.2023.11.032. Epub 2023 Nov 24.

Reference Type RESULT
PMID: 38035866 (View on PubMed)

Other Identifiers

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C22-51

Identifier Type: -

Identifier Source: org_study_id

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