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Postpartum WomenQuReSNCT05077891

Postpartum Quality of Recovery & Maternal Satisfaction After C/S

An observational study of Postpartum Women, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Measuring patient-oriented outcomes and satisfaction is important to guide meaningful changes in obstetric anesthesia care. Quality of Recovery (QoR) scores are patient rated measures, which provide a global measure of recovery after surgery. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Postpartum Women
How many people
300 participants
Where
1 siteCanada
Study dates
1 Aug 2021to 17 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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 19 years and older
  • Women only
  • Adult, Older adult

Study population: All women above the age of 19 years old whom underwent a caesarean section will be eligible to participate. Women will be surveyed at 24 hours after their cesarean section. Data will be collected by means of validated paper questionnaires administered in person by a study investigator that is not part of clinical care.

Who may be able to join

  • Fluent English speaker
  • Older than 19 years of age
  • Received a cesarean delivery
  • Received a cesarean delivery 24-48 hours prior to time of recruitment

Who cannot join

  • Non-English speaker
  • Below the age of 19 years
  • Did not receive a cesarean delivery
  • Received a cesarean delivery more than 48hrs after time of recruitment

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Women's Hospital

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

Official title: Relationship Between Patient Reported Postpartum Quality of Recovery and Maternal Satisfaction After Cesarean Delivery: A Prospective Observational Study

Measuring patient-oriented outcomes and satisfaction is important to guide meaningful changes in obstetric anesthesia care. Quality of Recovery (QoR) scores are patient rated measures, which provide a global measure of recovery after surgery. They go beyond the measure of physiological variables to include, physical, cognitive, emotive and functional outcomes. Satisfaction, in addition to QoR scores after anaesthesia is an important quality marker. Measuring satisfaction after the birth of a child is a complex and emotive subject. Understanding the factors that can influence maternal satisfaction may improve patient-centred care. Studies have shown that despite favorable clinical outcomes, many women undergoing caesarean deliveries continue to have poor experience with anaesthesia. These poor experiences go beyond inadequate pain control; many are due to poor communication with clinicians, lack of involvement in decision making, lack of provision of high quality education and information and a feeling of inadequate choice and control relating to decisions of the birth of their babies. In non-obstetric studies, satisfaction after anaesthesia has consistently been shown to be dependent on the information patient has received along with the quality of the communication and the quality of the anaesthetist-patient relationship.

What is being measured

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

  1. Quality of Recovery Score (ObsQoR-11)

    Quality of recovery will be measured using the obstetric quality of recovery score (ObsQoR-11). This is a 11-item, multidimensional recovery scoring tool, which has been validated in this population

    Measured: 5 Minutes

  2. Maternal Satisfaction Scale for Cesarean Section (MSSCS)

    This 22 item questionnaire measures satisfaction with the anaesthetic, needle insertion, side effects and the theatre atmosphere. Items are rated on a 7-point likert scale from strongly disagree to strongly agree.

    Measured: 5 Minutes

  3. Satisfaction with Received Care

    First open ended question assessing: "What aspects of your care were you most satisfied with?"

    Measured: 1 Minute

  4. Dissatisfaction with Received Care

    Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"

    Measured: 1 Minute

  5. Improvement of Satisfaction

    Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"

    Measured: 1 Minute

Secondary outcomes (25)

  1. Obstetric History: Gravidity and Preterm

    Total frequency of gravidity and preterm

    Measured: 1 Minute

  2. Patient Age

    Patient age in years

    Measured: 1 Minute

  3. Gestational Age

    Gestational age in total weeks and days

    Measured: 1 Minute

  4. Patient Height

    Patient height measured in centimeters

    Measured: 1 Minute

  5. Patient Weight

    Patient weight measured in kilograms

    Measured: 1 Minute

  6. Outcome of Delivery

    Result of singleton, twins, or other

    Measured: 1 Minute

  7. Neonatal APGARs

    APGAR scores at 1 minute and minutes

    Measured: 1 Minute

  8. Neonatal Birthweight

    Neonatal birthweight measured in grams

    Measured: 1 Minute

  9. Patient ASA Status

    American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6

    Measured: 1 Minute

  10. Pregnancy Medical Conditions

    Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.

    Measured: 1 Minute

  11. Medical Conditions Outside Pregnancy

    Including any medical conditions that do not constitute a pregnancy medical condition

    Measured: 1 Minute

  12. Neuraxial Lidocaine

    Neuraxial agents and dosage administered prior and during the cesarean section procedure.

    Measured: 1 Minute

  13. Neuraxial Bupivicaine

    dosage administered prior and during the cesarean section procedure.

    Measured: 1 Minute

  14. Neuraxial Morphine

    dosage administered prior and during the cesarean section procedure.

    Measured: 1 Minute

  15. Neuraxial Fentanyl

    dosage administered prior and during the cesarean section procedure.

    Measured: 1 Minute

  16. Intraoperative Anxiolytics

    Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.

    Measured: 1 Minute

  17. Anesthesia Procedure Start

    Time in military time format

    Measured: 1 Minute

  18. Urgency of Cesarean Delivery

    Classified as: scheduled, STAT, P1, or P2

    Measured: 1 Minute

  19. Indication for Cesarean Delivery

    Reason for cesarean delivery

    Measured: 1 Minute

  20. Labour Onset

    Indicated as: spontaneous, augmented, or induction of labour

    Measured: 1 Minute

  21. Labour Length

    Length of hours for both first stage and second stage

    Measured: 1 Minute

  22. Pain Relief During Labour

    Indicated as: epidural/CSE/DPE, Entonox, M\&G, or other

    Measured: 1 Minute

  23. Intraoperative Complications

    Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.

    Measured: 1 Minute

  24. Intraoperative Blood Loss

    Blood loss measured in milliliters.

    Measured: 1 Minute

  25. Postoperative Complications

    Any medical complication indicated after the caesarean delivery.

    Measured: 1 Minute

Timeline

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

  1. First posted14 Oct 2021
  2. Study start1 Aug 2021
  3. Primary completion15 Jan 2022
  4. Study completion17 Jun 2024

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
Cross-sectional
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077891
Sponsor's protocol ID
H21-01082
Acronym
QuReS
Status last verified
Feb 2025
First submitted
30 Sep 2021
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

    PubMed 30579408

  • Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014 Nov;69(11):1266-78. doi: 10.1111/anae.12730. Epub 2014 Jun 2.

    PubMed 24888412

  • Heidegger T, Saal D, Nubling M. Patient satisfaction with anaesthesia - Part 1: satisfaction as part of outcome - and what satisfies patients. Anaesthesia. 2013 Nov;68(11):1165-72. doi: 10.1111/anae.12347. Epub 2013 Aug 8.

    PubMed 23926924

  • Barnett SF, Alagar RK, Grocott MP, Giannaris S, Dick JR, Moonesinghe SR. Patient-satisfaction measures in anesthesia: qualitative systematic review. Anesthesiology. 2013 Aug;119(2):452-78. doi: 10.1097/ALN.0b013e3182976014.

    PubMed 23669268

  • Camann W. Pain, Pain Relief, Satisfaction and Excellence in Obstetric Anesthesia: A Surprisingly Complex Relationship. Anesth Analg. 2017 Feb;124(2):383-385. doi: 10.1213/ANE.0000000000001676. No abstract available.

    PubMed 28098685

  • Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44.

  • Linda D. Results of the National Maternity Experience Survey 2020 2020 [Available from: https://yourexperience.ie/maternity/national-results/.

  • Porter M, van Teijlingen E, Chi Ying Yip L, Bhattacharya S. Satisfaction with cesarean section: qualitative analysis of open-ended questions in a large postal survey. Birth. 2007 Jun;34(2):148-54. doi: 10.1111/j.1523-536X.2007.00161.x.

    PubMed 17542819

  • Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

    PubMed 7728691

  • Cook K, Loomis C. The Impact of Choice and Control on Women's Childbirth Experiences. J Perinat Educ. 2012 Summer;21(3):158-68. doi: 10.1891/1058-1243.21.3.158.

    PubMed 23730127

  • Brooks H, Sullivan WJ. The importance of patient autonomy at birth. Int J Obstet Anesth. 2002 Jul;11(3):196-203. doi: 10.1054/ijoa.2002.0958.

    PubMed 15321548

  • 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

  • Berning V, Laupheimer M, Nubling M, Heidegger T. Influence of quality of recovery on patient satisfaction with anaesthesia and surgery: a prospective observational cohort study. Anaesthesia. 2017 Sep;72(9):1088-1096. doi: 10.1111/anae.13906. Epub 2017 May 16.

    PubMed 28510285

  • Myles PS, Reeves MD, Anderson H, Weeks AM. Measurement of quality of recovery in 5672 patients after anaesthesia and surgery. Anaesth Intensive Care. 2000 Jun;28(3):276-80. doi: 10.1177/0310057X0002800304.

    PubMed 10853209

  • Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2.

    PubMed 30885691

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Women, run by University of British Columbia at 1 site in Canada.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery Score (ObsQoR-11) (time frame: 5 Minutes). The study lists 5 primary outcomes in all. 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 NCT05077891, which also lists 16 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 19 Feb 2025.

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