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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2020-07-31
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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EXIT scale
completion of EXIT scale translated in french
Eligibility Criteria
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Inclusion Criteria
* 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 who do not have an internet connection and an e-mail address.
* Patients under legal protection (guardianship, tutorship).
18 Years
FEMALE
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Denis Gallot
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A01286-33.
Identifier Type: OTHER
Identifier Source: secondary_id
RNI 2020 GALLOT
Identifier Type: -
Identifier Source: org_study_id
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