Clinical trial NCT04423081: Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Induction of Labor
Keywords: EXIT scale
induction of labor
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having given birth in the obstetrics department of CHU Estaing, Clermont-Ferrand with an induction of labor and with an unfavorable cervix (Bishop score \<6)

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.

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).

Primary outcomes:
measure: The psychometric properties of the French version of the EXperiences of Induction Tool
timeFrame: Day 2
Secondary outcomes:
measure: Score of the EXperiences of Induction Tool
timeFrame: Day 2
measure: Time of birth
timeFrame: at birth
measure: time of labor start
timeFrame: at birth
measure: Methods of induction of labor
timeFrame: at birth
measure: Maternal complications
timeFrame: up to 1 week
measure: Neonatal complications
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Denis Gallot
role: PRINCIPAL_INVESTIGATOR
References: