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NCT Number: NCT07555353

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

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.

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Key information

Conditions

Post-Cesarean Maternal Satisfaction Scale

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post-Cesarean Maternal Satisfaction Scale Questionnaire

Other

consists of beta-testing the MSSCS on 10 cesarean patients to assess item clarity and comprehension, followed by analysis, minor revisions, and finalization of the translated scale in accordance with ISPOR guidelines. A final report will document all translation and cultural adaptation decisions. This phase 2 involves administering the finalized French version of the MSSCS, along with QEVA and a global visual analog scale, to eligible women after cesarean section during their maternity stay to evaluate satisfaction.

Primary outcomes

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.

Secondary outcomes

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
- 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)
- Smoking during the peripartum period
- Degree of cesarean section urgency according to the Lucas classification (immediate, urgent, urgent elective, elective)
- Epidural anesthesia versus spinal anesthesia
- Hypnotic communication by the anesthesia team during the cesarean section
- Presence or absence of a support person during the cesarean section
- Immediate obstetric complication
- Immediate anesthetic complication
- Maternal transfer to intensive care
- Neonatal transfer to intensive care

Study contacts

Contact information is provided by the study sponsor or research team.

Angélina AP Pollet

CONTACT

[email protected]

04 76 76 67 29 ext. +33

Jean Noel EJ EVAIN, Doctor

CONTACT

[email protected]

04 76 76 67 29 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: TRANSALPINE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 29, 2026
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.