Translation and Validation Into French of a Maternal Satisfaction Scale Following a Cesarean Section (MSSCS) (TRANSALPINE)

April 23, 2026 updated by: University Hospital, Grenoble

Translation and Validation Into French of a Maternal Satisfaction Scale Following a Cesarean Section

Cesarean section is currently the most commonly performed surgical procedure worldwide, accounting for more than one-fifth of all deliveries in France. The experience of childbirth, particularly when it involves a cesarean section, is a significant life event with physical, psychological, and relational consequences. Many factors influence women's perceptions of this experience, including whether the procedure was planned or unexpected, the quality of analgesia, communication with healthcare providers, and the degree of involvement in decision-making. Conversely, a negative experience may impair the mother infant bond or delay postpartum recovery. The quality of anesthetic management is a major determinant of maternal satisfaction.

Maternal satisfaction is widely recognized as an important indicator of healthcare quality. Its assessment requires a multidimensional approach. Although several tools exist in French to measure satisfaction during pregnancy or childbirth in general, none are specifically designed to evaluate the experience of cesarean section, with its particular features-especially those related to anesthesia. Scales such as Questionnaire for the Evaluation of the Childbirth Experience (QEVA) or Women's Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ4) do not sufficiently address the specific characteristics of this procedure.

The Maternal Satisfaction Scale for Caesarean Section (MSSCS), originally developed in English, is currently the only validated instrument specifically designed to assess women's satisfaction following a cesarean section. It covers the anesthetic, technical, psychological, and environmental dimensions of the procedure. To date, this scale has neither been translated nor validated in French.

The availability of a validated French version of the MSSCS would improve the assessment of maternal experience in French-speaking settings and help identify concrete areas for improvement in anesthetic and obstetric care related to cesarean section.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-center, non-interventional study focuses on a specific population of women undergoing cesarean section and is conducted in two phases, including a questionnaire validation process.

The first phase involves the translation and cultural adaptation of the Maternal Satisfaction Scale for Caesarean Section (MSSCS) in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. This phase includes several steps: forward translation by two independent translators (one physician and one non-physician), reconciliation of the translated versions, back-translation, harmonization by an expert committee, pilot testing with 10 patients, and finalization of the scale.

The second phase consists of administering the translated questionnaire to a sample of women who have delivered by cesarean section at the Hôpital Couple Enfant of Grenoble Alpes University Hospital during their maternity stay. Two additional satisfaction assessment tools (QEVA) and a global Visual Analog Scale will also be administered. Eligible patients will be informed both orally and in writing shortly after their cesarean section. If they agree to participate, they will complete the questionnaires on postoperative day 1 whenever possible, or at another time during their hospitalization, without any modification to their standard care. This phase will allow field testing of the final French version of the scale and enable its psychometric validation.

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient who underwent a cesarean section under regional anesthesia at the Couple Enfant Hospital

Description

Inclusion Criteria:

  • Patient on Day 1, Day 2, or Day 3 following a cesarean section performed under regional anesthesia at the Couple Enfant Hospital of the CHUGA
  • Patient of legal age at the time of the cesarean section

Exclusion Criteria:

  • Patients who underwent a cesarean section under general anesthesia
  • Patients who underwent a cesarean section under deep sedation (this criterion will be verified by asking: "Do you remember your cesarean section?")
  • Patients who were placed on mechanical ventilation and/or under sedation in the intensive care unit following their cesarean section
  • Patient opposed to the use of her data for research purposes
  • Non-French-speaking patient
  • Patient who cannot read or write
  • Patient with cognitive or psychiatric disorders preventing her from understanding the questionnaire
  • Patient under legal guardianship or conservatorship, or deprived of liberty
  • Patient not enrolled in the social security system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Translate and validate the "Maternal Satisfaction Scale for Caesarean Section" (MSSCS) questionnaire into French
Time Frame: from day 1 to day 3
The translation will be conducted in accordance with the recommendations of ISPOR (International Society for Pharmacoeconomics and Outcomes Research) to ensure content validity. Other validity criteria to be assessed will include acceptability and feasibility, reliability, construct validity, and convergent validity.
from day 1 to day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare MSSCS scores based on factors that may influence the cesarean section experience : to demonstrate to study the determinants (known from the literature or hypothesized by the authors) of post-cesarean satisfaction at the Couple Enfant Hospital
Time Frame: from day 1 to day 3

  1. Obstetric context according to Robson's classification (into 10 groups based on the following 6 criteria:

    • Parity (nulliparous or multiparous)
    • History of cesarean section
    • Onset of labor (spontaneous, induced, or cesarean section before labor)
    • Number of fetuses (singleton or multiple)
    • Presentation (cephalic, breech, transverse)
    • Gestational age (≥ 37 weeks or < 37 weeks)
  2. Smoking during the peripartum period
  3. Degree of cesarean section urgency according to the Lucas classification (immediate, urgent, urgent elective, elective)
  4. Epidural anesthesia versus spinal anesthesia
  5. Hypnotic communication by the anesthesia team during the cesarean section
  6. Presence or absence of a support person during the cesarean section
  7. Immediate obstetric complication
  8. Immediate anesthetic complication
  9. Maternal transfer to intensive care
  10. Neonatal transfer to intensive care
from day 1 to day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC25.0398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be anonymized and stored at the University Hospital Grenoble

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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