Skip to main content
Clinical Trials/NCT04423081
NCT04423081
Unknown
N/A

Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth

University Hospital, Clermont-Ferrand1 site in 1 country130 target enrollmentJuly 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Induction of Labor
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
130
Locations
1
Primary Endpoint
The psychometric properties of the French version of the EXperiences of Induction Tool
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2020
End Date
January 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

The psychometric properties of the French version of the EXperiences of Induction Tool

Time Frame: Day 2

The psychometric properties of the French version of the EXperiences of Induction Tool include: acceptability, internal structure validity, convergent validity, structure validity against external criteria and reproducibility. EXperiences of Induction Tool is composed of 3 dimensions: "Time taken to give birth", "Discomfort with IOL" and "Experience of subsequent contractions". Each dimension has a minimum score of 0 and a maximum score of 5. For the dimension "Time taken to give birth, a high score mean a more positive feeling. For "Discomfort with IOL"a high score mean more discomfort. For "Experience of subsequent contractions", a high score mean a more positive feeling.

Secondary Outcomes

  • time of labor start(at birth)
  • Neonatal complications(up to 1 week)
  • Time of birth(at birth)
  • Score of the EXperiences of Induction Tool(Day 2)
  • Methods of induction of labor(at birth)
  • Maternal complications(up to 1 week)

Study Sites (1)

Loading locations...

Similar Trials