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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic decision tool | Other | A therapeutic decision tool will be used and its usefulness, comprehension and satisfaction will be evaluated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One day |
| To evaluate satisfaction of women and of doctor in using the tool |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de gynécologie-obstétrique - Ch Montargis | Amilly | 45200 | France | |||
| Service de Gynécologie-obstétrique - CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38035866 | Result | 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. |
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Prospective mulicentric study
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A specific questionnaire using Likert scale will be used |
| One day |
| Angers |
| ANGERS cedex 09 |
| France |
| Service de gynécologie-obstétrique - Hôpital Femme Mère Enfant | Bron | 69677 Bron cedex | France |
| Service de gynécologie-obstétrique - CHU Caen | Caen | 14 033 Caen Cedex 09 | France |
| Service de Gynécologie-obstétrique - CHU Estaing | Clermont-Ferrand | 63003 Clermont-Ferrand cedex | France |
| Service Gynécologie - Hopital Bicêtre | Le Kremlin-Bicêtre | 94275 Kremlin Bicêtre Cedex | France |
| Service de gynécologie-obstétrique - CH Saint Vincent de Paul et Saint Philibert | Lille | 59000 | France |
| Service de Gynécologie-obstétrique - Hopital Jeanne de Flandre | Lille | 59307 Lille Cedex | France |
| Service de gynécologie-obstétrique - Hopital Croix Rousse | Lyon | 69000 | France |
| Service de gynécologie-obstétrique -CHU Arnaud De Villeneuve | Montpellier | 34295 Montpellier cedex 5 | France |
| Sevrice de gynécologie-obstétrique - CHU Nantes | Nantes | France |
| Service de Gynécologie-obstétrique - CHU Nîmes - | Nîmes | 3000 | France |
| Service de gynécologie-obstétrique - CHU Rennes | Rennes | France |
| Service de gynécologie-obstétrique - CHU St Etienne | Saint-Etienne | 42100 | France |
| Service de gynécologie-obstétrique - CHU Tours bretonneau | Tours | 37044 Tours Cedex 01 | France |