To Validate a Decision Aid for Ectopic PregnancyGEUDECIDNCT05745831
Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study
A study testing Therapeutic decision tool in people with To Validate a Decision Aid for Ectopic Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- To Validate a Decision Aid for Ectopic Pregnancy
- What is being tested?
- Therapeutic decision tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 15 sitesFrance
- Study dates
- 22 Oct 2023to 22 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cardiac activity present in the embryo
- Hemoperitoin
- Hemodynamic instability
- Spontaneous pelvic pain
- Contre indication to methotrexate
- Protected adult patient
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Service de gynécologie-obstétrique - Ch Montargis
Amilly, 45200
Service de Gynécologie-obstétrique - CHU Angers
Angers, ANGERS cedex 09
Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant
Bron, 69677 Bron cedex
Service de gynécologie-obstétrique - CHU Caen
Caen, 14 033 Caen Cedex 09
Service de Gynécologie-obstétrique - CHU Estaing
Clermont-Ferrand, 63003 Clermont-Ferrand cedex
Service Gynécologie - Hopital Bicêtre
Le Kremlin-Bicêtre, 94275 Kremlin Bicêtre Cedex
Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert
Lille, 59000
Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre
Lille, 59307 Lille Cedex
Service de gynécologie-obstétrique - Hopital Croix Rousse
Lyon, 69000
Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve
Montpellier, 34295 Montpellier cedex 5
Sevrice de gynécologie-obstétrique - CHU Nantes
Nantes
Service de Gynécologie-obstétrique - CHU Nîmes -
Nîmes, 3000
Service de gynécologie-obstétrique - CHU Rennes
Rennes
Service de gynécologie-obstétrique - CHU St Etienne
Saint-Etienne, 42100
Service de gynécologie-obstétrique - CHU Tours bretonneau
Tours, 37044 Tours Cedex 01
About this study
Official title: Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
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.
Read the 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.
- Being tested
- Therapeutic decision tool
- Keywords
- decision aid, shared decision making, less active ectopic pregnancy, methotrexate, medical treatment, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic decision toolOther
A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision | Experimental | 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 Receives: Other: Therapeutic decision tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (2)
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
Measured: One day
To evaluate satisfaction of women and of doctor in using the tool
A specific questionnaire using Likert scale will be used
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start22 Oct 2023
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Validate a Decision Aid for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective mulicentric study
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745831
- Sponsor's protocol ID
- C22-51
- Acronym
- GEUDECID
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38035866