Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study
- Conditions
- To Validate a Decision Aid for Ectopic Pregnancy
- Interventions
- Other: Therapeutic decision tool
- Registration Number
- NCT05745831
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 109
- 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
- Cardiac activity present in the embryo
- Hemoperitoin
- Hemodynamic instability
- Spontaneous pelvic pain
- Contre indication to methotrexate
- Protected adult patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision Therapeutic decision tool 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
- Primary Outcome Measures
Name Time Method Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy. 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.
- Secondary Outcome Measures
Name Time Method To evaluate satisfaction of women and of doctor in using the tool One day A specific questionnaire using Likert scale will be used
Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy. One day The same Traditional Decisional Conflict Scale (DCS) will be used in gynecologist who will managed the women
Trial Locations
- Locations (15)
Service de gynécologie-obstétrique - Ch Montargis
🇫🇷Amilly, France
Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert
🇫🇷Lille, France
Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre
🇫🇷Lille, France
Service de gynécologie-obstétrique - Hopital Croix Rousse
🇫🇷Lyon, France
Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve
🇫🇷Montpellier, France
Service de Gynécologie-obstétrique - CHU Angers
🇫🇷Angers, France
Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant
🇫🇷Bron, France
Service de gynécologie-obstétrique - CHU Caen
🇫🇷Caen, France
Service de Gynécologie-obstétrique - CHU Estaing
🇫🇷Clermont-Ferrand, France
Service Gynécologie - Hopital Bicêtre
🇫🇷Kremlin Bicêtre, France
Sevrice de gynécologie-obstétrique - CHU Nantes
🇫🇷Nantes, France
Service de gynécologie-obstétrique - CHU St Etienne
🇫🇷Saint Etienne, France
Service de gynécologie-obstétrique - CHU Tours bretonneau
🇫🇷Tours, France
Service de Gynécologie-obstétrique - CHU Nîmes -
🇫🇷Nîmes, France
Service de gynécologie-obstétrique - CHU Rennes
🇫🇷Rennes, France