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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Therapeutic Decision Aid in Less Active Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT05745831
- Acronym / sponsor ID
- GEUDECID / C22-51
- Keywords
- decision aid, shared decision making, less active ectopic pregnancy, methotrexate, medical treatment, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective mulicentric study
| Arm | Type | Receives |
|---|---|---|
| Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision | Experimental | Other: Therapeutic decision toolWomen 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Cardiac activity present in the embryo
- Hemoperitoin
- Hemodynamic instability
- Spontaneous pelvic pain
- Contre indication to methotrexate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic decision toolA therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated | Other | Women with a less active ectopic pregnancy using a therapeutic decision tool for treatment decision |
Primary outcome
Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy.
Time frame: 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.
2 secondary outcomes
Validate acceptability of the therapeutic decision tool in doctors who managed women for less active ectopic tubal pregnancy.
Time frame: One day
To evaluate satisfaction of women and of doctor in using the tool
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Results publication: PubMed 38035866Capmas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate acceptability of the therapeutic decision tool in women managed for less active ectopic tubal pregnancy. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.