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

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.

Study Overview

• Status: Unknown
• Conditions: Induction of Labor
• Intervention / Treatment: Other: EXIT scale

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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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)

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The psychometric properties of the French version of the EXperiences of Induction Tool	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.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the EXperiences of Induction Tool	Score 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 IOL"a high score mean more discomfort. For "Experience of subsequent contractions", a high score mean a more positive feeling.	Day 2
Time of birth	delay between induction of labor and birth will be calculated	at birth
time of labor start	delay between induction of labor and labor start will be calculated	at birth
Methods of induction of labor	the type of strategy used for induction of labor will be recored	at birth
Maternal complications	maternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy	up to 1 week
Neonatal complications	maternal 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	up to 1 week

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: induction of labor; EXIT scale
• Other Study ID Numbers: RNI 2020 GALLOT; 2020-A01286-33. (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No