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

NCT04423081 | Unknown

• 2 other identifiers: RNI 2020 GALLOT2020-A01286-33.
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor

Keywords

EXIT scale; induction of labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Score of the EXperiences of Induction Tool

  Day 2

• Time of birth

  at birth

• time of labor start

  at birth

• Methods of induction of labor

  at birth

• Maternal complications

  up to 1 week

Interventions

EXIT scale OTHER

completion of EXIT scale translated in french

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Study Officials

• Denis Gallot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-05

Locations

FR (1)