Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Induction of Labor 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: EXIT scale
    completion of EXIT scale translated in french


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Time of birth [ Time Frame: at birth ]
    delay between induction of labor and birth will be calculated

  3. time of labor start [ Time Frame: at birth ]
    delay between induction of labor and labor start will be calculated

  4. Methods of induction of labor [ Time Frame: at birth ]
    the type of strategy used for induction of labor will be recored

  5. Maternal complications [ Time Frame: up to 1 week ]
    maternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423081


Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE +33473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    +33473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Denis Gallot         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Denis Gallot University Hospital, Clermont-Ferrand
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04423081    
Other Study ID Numbers: RNI 2020 GALLOT
2020-A01286-33. ( Other Identifier: ANSM )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
EXIT scale
induction of labor