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

Institut National de la Santé Et de la Recherche Médicale, France109 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

109

Conditions

To Validate a Decision Aid for Ectopic Pregnancy

Interventions

Therapeutic decision toolOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (15)

Service de gynécologie-obstétrique - Ch Montargis

Amilly, France

Service de Gynécologie-obstétrique - CHU Angers

Angers, France

Outcomes

Primary Outcomes

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.

Time frame: One day

Secondary Outcomes

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

Time frame: One day

To evaluate satisfaction of women and of doctor in using the tool

A specific questionnaire using Likert scale will be used

Time frame: One day

Data from ClinicalTrials.gov

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