Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)

NCT ID: NCT04423081

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Favourable agreement was obtained from the authors to adapt the Australian moose tool in a cross-cultural manner. None of the co-authors expressed a desire to collaborate on our project. The EXIT questionnaire is free of rights.

The translation of the EXIT questionnaire into French will be carried out according to the recommended steps of the cross-cultural adaptation process (21, 22, 25): translation of the source version into French by three native French translators, adaptation of the different translations by a group of experts, back translation by two native English speakers, testing with a panel of women who have been triggered for childbirth, in order to arrive at the final version which will be evaluated in a sample of the target population.

Information about the study will be given to women between Day 2 and Day 4 postpartum. Patients' non-opposition to participate in this study will be collected in the patient's medical record.

Recruitment of subjects: the study will be proposed to all eligible women who have been induced for their delivery and with an unfavourable cervix in the obstetrics department of the CHU Estaing, Clermont-Ferrand.

Completion of the questionnaire: women will complete the EXIT self-questionnaire between D2 and D4 post-delivery.

The data collection will include additional socio-demographic and clinical information for each woman participating in the study from their medical records.

The test-retest involves filling in the EXIT questionnaire twice at one to two week intervals.

The women will be contacted by phone one week after the first EXIT test, to inform them that a link will be sent by e-mail to complete the EXIT questionnaire online (on Redcap) a second time. They will be called back a second time a week later if the questionnaire is not completed online.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EXIT scale

completion of EXIT scale translated in french

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients having given birth in the obstetrics department of CHU Estaing, Clermont-Ferrand
* with an induction of labor
* with an unfavorable cervix (Bishop score \<6)
* on living child(ren)
* Patients aged 18 years and over, understanding, speaking and reading French
* no object to participating in the study.

Exclusion Criteria

* Patients induced at first with syntocinon.
* Patients who do not have an internet connection and an e-mail address.
* Patients under legal protection (guardianship, tutorship).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Denis Gallot

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lise LACLAUTRE

Role: CONTACT

+33473754963

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lise Laclautre

Role: primary

+33473754963

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A01286-33.

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2020 GALLOT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Doulas as Environmental Educators and Partners Study
NCT06032143 ACTIVE_NOT_RECRUITING NA
MOTIVAC-MATER-Confiance
NCT05093452 COMPLETED NA
Infant Feeding in French Guiana
NCT06528275 RECRUITING