- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077891
Postpartum Quality of Recovery & Maternal Satisfaction After C/S (QuReS)
February 15, 2025 updated by: Anthony Chau, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3N1
- BC Women's Hospital
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery Score (ObsQoR-11)
Time Frame: 5 Minutes
|
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
|
5 Minutes
|
|
Maternal Satisfaction Scale for Cesarean Section (MSSCS)
Time Frame: 5 Minutes
|
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.
|
5 Minutes
|
|
Satisfaction with Received Care
Time Frame: 1 Minute
|
First open ended question assessing: "What aspects of your care were you most satisfied with?"
|
1 Minute
|
|
Dissatisfaction with Received Care
Time Frame: 1 Minute
|
Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"
|
1 Minute
|
|
Improvement of Satisfaction
Time Frame: 1 Minute
|
Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"
|
1 Minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obstetric History: Gravidity and Preterm
Time Frame: 1 Minute
|
Total frequency of gravidity and preterm
|
1 Minute
|
|
Patient Age
Time Frame: 1 Minute
|
Patient age in years
|
1 Minute
|
|
Gestational Age
Time Frame: 1 Minute
|
Gestational age in total weeks and days
|
1 Minute
|
|
Patient Height
Time Frame: 1 Minute
|
Patient height measured in centimeters
|
1 Minute
|
|
Patient Weight
Time Frame: 1 Minute
|
Patient weight measured in kilograms
|
1 Minute
|
|
Outcome of Delivery
Time Frame: 1 Minute
|
Result of singleton, twins, or other
|
1 Minute
|
|
Neonatal APGARs
Time Frame: 1 Minute
|
APGAR scores at 1 minute and minutes
|
1 Minute
|
|
Neonatal Birthweight
Time Frame: 1 Minute
|
Neonatal birthweight measured in grams
|
1 Minute
|
|
Patient ASA Status
Time Frame: 1 Minute
|
American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6
|
1 Minute
|
|
Pregnancy Medical Conditions
Time Frame: 1 Minute
|
Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.
|
1 Minute
|
|
Medical Conditions Outside Pregnancy
Time Frame: 1 Minute
|
Including any medical conditions that do not constitute a pregnancy medical condition
|
1 Minute
|
|
Intraoperative Anxiolytics
Time Frame: 1 Minute
|
Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.
|
1 Minute
|
|
Anesthesia Procedure Start
Time Frame: 1 Minute
|
Time in military time format
|
1 Minute
|
|
Urgency of Cesarean Delivery
Time Frame: 1 Minute
|
Classified as: scheduled, STAT, P1, or P2
|
1 Minute
|
|
Indication for Cesarean Delivery
Time Frame: 1 Minute
|
Reason for cesarean delivery
|
1 Minute
|
|
Labour Onset
Time Frame: 1 Minute
|
Indicated as: spontaneous, augmented, or induction of labour
|
1 Minute
|
|
Labour Length
Time Frame: 1 Minute
|
Length of hours for both first stage and second stage
|
1 Minute
|
|
Pain Relief During Labour
Time Frame: 1 Minute
|
Indicated as: epidural/CSE/DPE, Entonox, M&G, or other
|
1 Minute
|
|
Intraoperative Complications
Time Frame: 1 Minute
|
Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.
|
1 Minute
|
|
Intraoperative Blood Loss
Time Frame: 1 Minute
|
Blood loss measured in milliliters.
|
1 Minute
|
|
Postoperative Complications
Time Frame: 1 Minute
|
Any medical complication indicated after the caesarean delivery.
|
1 Minute
|
|
Neuraxial Lidocaine
Time Frame: 1 Minute
|
Neuraxial agents and dosage administered prior and during the cesarean section procedure.
|
1 Minute
|
|
Neuraxial Bupivicaine
Time Frame: 1 Minute
|
dosage administered prior and during the cesarean section procedure.
|
1 Minute
|
|
Neuraxial Morphine
Time Frame: 1 Minute
|
dosage administered prior and during the cesarean section procedure.
|
1 Minute
|
|
Neuraxial Fentanyl
Time Frame: 1 Minute
|
dosage administered prior and during the cesarean section procedure.
|
1 Minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anton Chau, MD MMSc, University of British Columbia
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
August 1, 2021
Primary Completion (Actual)
January 15, 2022
Study Completion (Actual)
June 17, 2024
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
September 30, 2021
First Posted (Actual)
October 14, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 15, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- H21-01082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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