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

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

Status: Not yet enrolling

Conditions: To Validate a Decision Aid for Ectopic Pregnancy

Treatments: Other: Therapeutic decision tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05745831

C22-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

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

Experimental group

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

Treatment:

Other: Therapeutic decision tool