Clinical trial NCT05745831: Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study
Official title: Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Validate a Decision Aid for Ectopic Pregnancy
Keywords: decision aid
shared decision making
less active ectopic pregnancy
methotrexate
medical treatment
surgery
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-02-27
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective mulicentric study
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
timeFrame: One day
Secondary outcomes:
measure: Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy.
timeFrame: One day
measure: To evaluate satisfaction of women and of doctor in using the tool
timeFrame: One day
Other outcomes:
Locations:
city: Amilly
country: France
facility: Service de gynécologie-obstétrique - Ch Montargis
city: Angers
country: France
facility: Service de Gynécologie-obstétrique - CHU Angers
city: Bron
country: France
facility: Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant
city: Caen
country: France
facility: Service de gynécologie-obstétrique - CHU Caen
city: Clermont-Ferrand
country: France
facility: Service de Gynécologie-obstétrique - CHU Estaing
city: Kremlin Bicêtre
country: France
facility: Service Gynécologie - Hopital Bicêtre
city: Lille
country: France
facility: Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert
city: Lille
country: France
facility: Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre
city: Lyon
country: France
facility: Service de gynécologie-obstétrique - Hopital Croix Rousse
city: Montpellier
country: France
facility: Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve
city: Nantes
country: France
facility: Sevrice de gynécologie-obstétrique - CHU Nantes
city: Nîmes
country: France
facility: Service de Gynécologie-obstétrique - CHU Nîmes -
city: Rennes
country: France
facility: Service de gynécologie-obstétrique - CHU Rennes
city: Saint Etienne
country: France
facility: Service de gynécologie-obstétrique - CHU St Etienne
city: Tours
country: France
facility: Service de gynécologie-obstétrique - CHU Tours bretonneau
Study officials:
References: