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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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