BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Completed
NCT Number: NCT05077891
Postpartum Quality of Recovery & Maternal Satisfaction After C/S
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.
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Notify MeKey information
Conditions
Age range
19 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
-
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.
-
Satisfaction with Received Care
Time frame: 1 Minute
First open ended question assessing: "What aspects of your care were you most satisfied with?"
-
Dissatisfaction with Received Care
Time frame: 1 Minute
Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"
-
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?"
Secondary outcomes
-
Obstetric History: Gravidity and Preterm
Time frame: 1 Minute
Total frequency of gravidity and preterm
-
Patient Age
Time frame: 1 Minute
Patient age in years
-
Gestational Age
Time frame: 1 Minute
Gestational age in total weeks and days
-
Patient Height
Time frame: 1 Minute
Patient height measured in centimeters
-
Patient Weight
Time frame: 1 Minute
Patient weight measured in kilograms
-
Outcome of Delivery
Time frame: 1 Minute
Result of singleton, twins, or other
-
Neonatal APGARs
Time frame: 1 Minute
APGAR scores at 1 minute and minutes
-
Neonatal Birthweight
Time frame: 1 Minute
Neonatal birthweight measured in grams
-
Patient ASA Status
Time frame: 1 Minute
American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6
-
Pregnancy Medical Conditions
Time frame: 1 Minute
Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.
-
Medical Conditions Outside Pregnancy
Time frame: 1 Minute
Including any medical conditions that do not constitute a pregnancy medical condition
-
Neuraxial Lidocaine
Time frame: 1 Minute
Neuraxial agents and dosage administered prior and during the cesarean section procedure.
-
Neuraxial Bupivicaine
Time frame: 1 Minute
dosage administered prior and during the cesarean section procedure.
-
Neuraxial Morphine
Time frame: 1 Minute
dosage administered prior and during the cesarean section procedure.
-
Neuraxial Fentanyl
Time frame: 1 Minute
dosage administered prior and during the cesarean section procedure.
-
Intraoperative Anxiolytics
Time frame: 1 Minute
Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.
-
Anesthesia Procedure Start
Time frame: 1 Minute
Time in military time format
-
Urgency of Cesarean Delivery
Time frame: 1 Minute
Classified as: scheduled, STAT, P1, or P2
-
Indication for Cesarean Delivery
Time frame: 1 Minute
Reason for cesarean delivery
-
Labour Onset
Time frame: 1 Minute
Indicated as: spontaneous, augmented, or induction of labour
-
Labour Length
Time frame: 1 Minute
Length of hours for both first stage and second stage
-
Pain Relief During Labour
Time frame: 1 Minute
Indicated as: epidural/CSE/DPE, Entonox, M&G, or other
-
Intraoperative Complications
Time frame: 1 Minute
Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.
-
Intraoperative Blood Loss
Time frame: 1 Minute
Blood loss measured in milliliters.
-
Postoperative Complications
Time frame: 1 Minute
Any medical complication indicated after the caesarean delivery.
Sponsors and collaborators
Lead sponsor
University of British Columbia
Other
Registry information
Official study title
Relationship Between Patient Reported Postpartum Quality of Recovery and Maternal Satisfaction After Cesarean Delivery: A Prospective Observational Study
Acronym: QuReS
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2024
- First posted
- Oct 14, 2021
- Registry last updated
- Feb 19, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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