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Post-Cesarean Maternal Satisfaction ScaleTRANSALPINENCT07555353

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

An observational study of Post-Cesarean Maternal Satisfaction Scale, run by University Hospital, Grenoble.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Post-Cesarean Maternal Satisfaction Scale Questionnaire
How many people
210 participants
Where
No sites listed yet
Study dates
1 May 2026to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Post-Cesarean Maternal Satisfaction Scale Questionnaire
Keywords
caesaren, MSSCS Maternal satisfaction scale for ceasareran

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post-Cesarean Maternal Satisfaction Scale QuestionnaireOther

    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.

  • Post-Cesarean Maternal Satisfaction Scale QuestionnaireOther

    This phase 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. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Translate and validate the "Maternal Satisfaction Scale for Caesarean Section" (MSSCS) questionnaire into French

    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.

    Measured: from day 1 to day 3

Secondary outcomes (1)
  1. 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

    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)
    1. Smoking during the peripartum period
    2. Degree of cesarean section urgency according to the Lucas classification (immediate, urgent, urgent elective, elective)
    3. Epidural anesthesia versus spinal anesthesia
    4. Hypnotic communication by the anesthesia team during the cesarean section
    5. Presence or absence of a support person during the cesarean section
    6. Immediate obstetric complication
    7. Immediate anesthetic complication
    8. Maternal transfer to intensive care
    9. Neonatal transfer to intensive care

    Measured: from day 1 to day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555353
Sponsor's protocol ID
38RC25.0398
Acronym
TRANSALPINE
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be anonymized and stored at the University Hospital Grenoble

Publications

  • Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.

    PubMed 29481436
  • Nunnally JC, Bernstein IH. Psychometric theory. 3rd ed. New York: McGraw-Hill; 1994.

  • Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17.

    PubMed 28616007
  • Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May AE, Wee M, Robinson PN. Urgency of caesarean section: a new classification. J R Soc Med. 2000 Jul;93(7):346-50. doi: 10.1177/014107680009300703.

    PubMed 10928020
  • Betran AP, Vindevoghel N, Souza JP, Gulmezoglu AM, Torloni MR. A systematic review of the Robson classification for caesarean section: what works, doesn't work and how to improve it. PLoS One. 2014 Jun 3;9(6):e97769. doi: 10.1371/journal.pone.0097769. eCollection 2014.

    PubMed 24892928
  • Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.

    PubMed 15321139
  • Sword W, Heaman M, Peterson WE, Salvador A, Akhtar-Danesh N, Bradford-Janke A. Psychometric Testing of the French Language Quality of Prenatal Care Questionnaire. J Nurs Meas. 2015;23(3):436-51. doi: 10.1891/1061-3749.23.3.436.

    PubMed 26673769
  • Floris L, Mermillod B, Chastonay P. [Translation and validation in French of a multidimensional scale to evaluate the degree of satisfaction during childbirth]. Rev Epidemiol Sante Publique. 2010 Feb;58(1):13-22. doi: 10.1016/j.respe.2009.09.005. Epub 2010 Jan 25. French.

    PubMed 20097497
  • Vignaud M, Morel C, Henault A, Futier E, Pereira B, Lambert C, Beloeil H. Variability and reliability of the French version of the Quality of Recovery-40 Questionnaire (QoR-40). Anaesth Crit Care Pain Med. 2021 Apr;40(2):100822. doi: 10.1016/j.accpm.2021.100822. Epub 2021 Mar 12.

    PubMed 33722740
  • Nilver H, Begley C, Berg M. Measuring women's childbirth experiences: a systematic review for identification and analysis of validated instruments. BMC Pregnancy Childbirth. 2017 Jun 29;17(1):203. doi: 10.1186/s12884-017-1356-y.

    PubMed 28662645
  • Larkin P, Begley CM, Devane D. Women's experiences of labour and birth: an evolutionary concept analysis. Midwifery. 2009 Apr;25(2):e49-59. doi: 10.1016/j.midw.2007.07.010. Epub 2007 Nov 8.

    PubMed 17996342
  • Sobhy S, Zamora J, Dharmarajah K, Arroyo-Manzano D, Wilson M, Navaratnarajah R, Coomarasamy A, Khan KS, Thangaratinam S. Anaesthesia-related maternal mortality in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2016 May;4(5):e320-7. doi: 10.1016/S2214-109X(16)30003-1.

    PubMed 27102195
  • Abe H, Sumitani M, Uchida K, Ikeda T, Matsui H, Fushimi K, Yasunaga H, Yamada Y. Association between mode of anaesthesia and severe maternal morbidity during admission for scheduled Caesarean delivery: a nationwide population-based study in Japan, 2010-2013. Br J Anaesth. 2018 Apr;120(4):779-789. doi: 10.1016/j.bja.2017.11.101. Epub 2018 Feb 2.

    PubMed 29576118
  • Baldini V, Gnazzo M, De Ronchi D, Carotenuto M, Pera MC, Fiorillo A. Traumatic Childbirth Experiences and their Association with Postpartum Psychiatric Disorders: A Systematic Review. Psychiatr Q. 2025 Jul 8. doi: 10.1007/s11126-025-10180-4. Online ahead of print.

    PubMed 40627258
  • Bell AF, Andersson E. The birth experience and women's postnatal depression: A systematic review. Midwifery. 2016 Aug;39:112-23. doi: 10.1016/j.midw.2016.04.014. Epub 2016 May 7.

    PubMed 27321728

Questions about this trial

What is this clinical trial studying?

An observational study of Post-Cesarean Maternal Satisfaction Scale, run by University Hospital, Grenoble.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean Noel EJ EVAIN, Doctor (04 76 76 67 29 ext. +33, jnevain@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Translate and validate the "Maternal Satisfaction Scale for Caesarean Section" (MSSCS) questionnaire into French (time frame: from day 1 to day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07555353, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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