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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04423081
Acronym
EXIT
Enrollment
130
Registered
2020-06-09
Start date
2020-07-31
Completion date
2021-01-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor

Keywords

EXIT scale, induction of labor

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.

Interventions

OTHEREXIT scale

completion of EXIT scale translated in french

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The psychometric properties of the French version of the EXperiences of Induction ToolDay 2The 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 IOLa high score mean more discomfort. For Experience of subsequent contractions, a high score mean a more positive feeling.

Secondary

MeasureTime frameDescription
Time of birthat birthdelay between induction of labor and birth will be calculated
time of labor startat birthdelay between induction of labor and labor start will be calculated
Score of the EXperiences of Induction ToolDay 2Score of the EXperiences of Induction Tool will be calculated. 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 IOLa high score mean more discomfort. For Experience of subsequent contractions, a high score mean a more positive feeling.
Maternal complicationsup to 1 weekmaternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy
Neonatal complicationsup to 1 weekmaternal complications include Apgar score \< 7 to 5min, pH and lactates on umbilical arterial sampling, 2nd line operation, and rate of transfer to Intensive care unit, maternal-fetal infection
Methods of induction of laborat birththe type of strategy used for induction of labor will be recored

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026