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

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Induction of Labor

Treatments

Other: EXIT scale

Study type

Observational

Funder types

Other

Identifiers

NCT04423081
RNI 2020 GALLOT
2020-A01286-33. (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

1

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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