NCT07555353

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 15, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

caesarenMSSCS Maternal satisfaction scale for ceasareran

Outcome Measures

Primary Outcomes (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.

    from day 1 to day 3

Secondary Outcomes (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

    from day 1 to day 3

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

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

    BACKGROUND
  • 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.

    PMID: 28616007BACKGROUND
  • 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.

    PMID: 10928020BACKGROUND
  • 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.

    PMID: 24892928BACKGROUND
  • 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.

    PMID: 15321139BACKGROUND
  • 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.

    PMID: 26673769BACKGROUND
  • 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.

    PMID: 20097497BACKGROUND
  • 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.

    PMID: 33722740BACKGROUND
  • 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.

    PMID: 28662645BACKGROUND
  • 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.

    PMID: 17996342BACKGROUND
  • 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.

    PMID: 27102195BACKGROUND
  • 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.

    PMID: 29576118BACKGROUND
  • 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.

    PMID: 40627258BACKGROUND
  • 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.

    PMID: 27321728BACKGROUND
  • Gungor I, Beji NK. Development and psychometric testing of the scales for measuring maternal satisfaction in normal and caesarean birth. Midwifery. 2012 Jun;28(3):348-57. doi: 10.1016/j.midw.2011.03.009. Epub 2011 May 4.

    PMID: 21546142BACKGROUND
  • Henriksen L, Grimsrud E, Schei B, Lukasse M; Bidens Study Group. Factors related to a negative birth experience - A mixed methods study. Midwifery. 2017 Aug;51:33-39. doi: 10.1016/j.midw.2017.05.004. Epub 2017 May 8.

    PMID: 28528179BACKGROUND

Central Study Contacts

Jean Noel EJ EVAIN, Doctor

CONTACT

Angélina AP Pollet

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 29, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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