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

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ClinicalTrials.gov Identifier: NCT04423081
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date May 26, 2020
First Posted Date June 9, 2020
Last Update Posted Date June 9, 2020
Estimated Study Start Date July 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 8, 2020)
  • Score of the EXperiences of Induction Tool [ Time Frame: Day 2 ]
    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.
  • Time of birth [ Time Frame: at birth ]
    delay between induction of labor and birth will be calculated
  • time of labor start [ Time Frame: at birth ]
    delay between induction of labor and labor start will be calculated
  • Methods of induction of labor [ Time Frame: at birth ]
    the type of strategy used for induction of labor will be recored
  • Maternal complications [ Time Frame: up to 1 week ]
    maternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy
  • Neonatal complications [ Time Frame: up to 1 week ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Induction of Labor
Intervention Other: EXIT scale
completion of EXIT scale translated in french
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 8, 2020)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lise LACLAUTRE +33473754963 promo_interne_drci@chu-clermontferrand.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04423081
Other Study ID Numbers RNI 2020 GALLOT
2020-A01286-33. ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Denis Gallot University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date May 2020