Postpartum Quality of Recovery & Maternal Satisfaction After C/S

Quality of Recovery Clinical Trial

— QuReS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077891
• Other study ID #: H21-01082
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: Anton Chau, MD MMSc
• Phone: 6048752158
• Email: anton.chau[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Recovery

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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. Review. — View Citation

Berning V, Laupheimer M, Nübling 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. — View Citation

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. Review. — View Citation

Brooks H, Sullivan WJ. The importance of patient autonomy at birth. Int J Obstet Anesth. 2002 Jul;11(3):196-203. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Heidegger T, Saal D, Nübling 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. Review. — View Citation

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/.

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 Minutes
Primary	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.	5 Minutes
Primary	Satisfaction with Received Care	First open ended question assessing: "What aspects of your care were you most satisfied with?"	1 Minute
Primary	Dissatisfaction with Received Care	Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"	1 Minute
Primary	Improvement of Satisfaction	Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"	1 Minute
Secondary	Obstetric History: Gravidity and Preterm	Total frequency of gravidity and preterm	1 Minute
Secondary	Patient Age	Patient age in years	1 Minute
Secondary	Gestational Age	Gestational age in total weeks and days	1 Minute
Secondary	Patient Height	Patient height measured in centimeters	1 Minute
Secondary	Patient Weight	Patient weight measured in kilograms	1 Minute
Secondary	Outcome of Delivery	Result of singleton, twins, or other	1 Minute
Secondary	Neonatal APGARs	APGAR scores at 1 minute and minutes	1 Minute
Secondary	Neonatal Birthweight	Neonatal birthweight measured in grams	1 Minute
Secondary	Patient ASA Status	American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6	1 Minute
Secondary	Pregnancy Medical Conditions	Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.	1 Minute
Secondary	Medical Conditions Outside Pregnancy	Including any medical conditions that do not constitute a pregnancy medical condition	1 Minute
Secondary	Neuraxial Agents	Neuraxial agents and dosage administered prior and during the cesarean section procedure.	1 Minute
Secondary	Intraoperative Anxiolytics	Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.	1 Minute
Secondary	Anesthesia Procedure Start	Time in military time format	1 Minute
Secondary	Urgency of Cesarean Delivery	Classified as: scheduled, STAT, P1, or P2	1 Minute
Secondary	Indication for Cesarean Delivery	Reason for cesarean delivery	1 Minute
Secondary	Labour Onset	Indicated as: spontaneous, augmented, or induction of labour	1 Minute
Secondary	Labour Length	Length of hours for both first stage and second stage	1 Minute
Secondary	Pain Relief During Labour	Indicated as: epidural/CSE/DPE, Entonox, M&G, or other	1 Minute
Secondary	Intraoperative Complications	Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.	1 Minute
Secondary	Intraoperative Blood Loss	Blood loss measured in milliliters.	1 Minute
Secondary	Postoperative Complications	Any medical complication indicated after the caesarean delivery.	1 Minute