Postpartum Quality of Recovery & Maternal Satisfaction After C/S

Completed

• Conditions: Postpartum Women

• Registration Number: NCT05077891
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-14
• Primary Completion: 2022-01-15
• Study Completion: 2024-06-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Recovery Score (ObsQoR-11)	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
Satisfaction with Received Care	1 Minute	First open ended question assessing: "What aspects of your care were you most satisfied with?"
Improvement of Satisfaction	1 Minute	Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"
Maternal Satisfaction Scale for Cesarean Section (MSSCS)	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.
Dissatisfaction with Received Care	1 Minute	Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"

Secondary Outcome Measures

Name	Time	Method
Obstetric History: Gravidity and Preterm	1 Minute	Total frequency of gravidity and preterm
Patient Age	1 Minute	Patient age in years
Neonatal Birthweight	1 Minute	Neonatal birthweight measured in grams
Patient ASA Status	1 Minute	American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6
Pregnancy Medical Conditions	1 Minute	Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.
Medical Conditions Outside Pregnancy	1 Minute	Including any medical conditions that do not constitute a pregnancy medical condition
Neuraxial Lidocaine	1 Minute	Neuraxial agents and dosage administered prior and during the cesarean section procedure.
Neuraxial Morphine	1 Minute	dosage administered prior and during the cesarean section procedure.
Gestational Age	1 Minute	Gestational age in total weeks and days
Patient Weight	1 Minute	Patient weight measured in kilograms
Outcome of Delivery	1 Minute	Result of singleton, twins, or other
Neuraxial Fentanyl	1 Minute	dosage administered prior and during the cesarean section procedure.
Intraoperative Anxiolytics	1 Minute	Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.
Anesthesia Procedure Start	1 Minute	Time in military time format
Urgency of Cesarean Delivery	1 Minute	Classified as: scheduled, STAT, P1, or P2
Pain Relief During Labour	1 Minute	Indicated as: epidural/CSE/DPE, Entonox, M\&G, or other
Patient Height	1 Minute	Patient height measured in centimeters
Neonatal APGARs	1 Minute	APGAR scores at 1 minute and minutes
Neuraxial Bupivicaine	1 Minute	dosage administered prior and during the cesarean section procedure.
Indication for Cesarean Delivery	1 Minute	Reason for cesarean delivery
Labour Onset	1 Minute	Indicated as: spontaneous, augmented, or induction of labour
Labour Length	1 Minute	Length of hours for both first stage and second stage
Intraoperative Blood Loss	1 Minute	Blood loss measured in milliliters.
Intraoperative Complications	1 Minute	Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.
Postoperative Complications	1 Minute	Any medical complication indicated after the caesarean delivery.

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada