QuReS: Postpartum Quality of Recovery & Maternal Satisfaction After C/S

Sponsor
University of British Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077891
Collaborator
(none)
300
1
7.5
39.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Relationship Between Patient Reported Postpartum Quality of Recovery and Maternal Satisfaction After Cesarean Delivery: A Prospective Observational Study
    Actual Study Start Date :
    Jul 15, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. Satisfaction with Received Care [1 Minute]

      First open ended question assessing: "What aspects of your care were you most satisfied with?"

    4. Dissatisfaction with Received Care [1 Minute]

      Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"

    5. Improvement of Satisfaction [1 Minute]

      Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"

    Secondary Outcome Measures

    1. Obstetric History: Gravidity and Preterm [1 Minute]

      Total frequency of gravidity and preterm

    2. Patient Age [1 Minute]

      Patient age in years

    3. Gestational Age [1 Minute]

      Gestational age in total weeks and days

    4. Patient Height [1 Minute]

      Patient height measured in centimeters

    5. Patient Weight [1 Minute]

      Patient weight measured in kilograms

    6. Outcome of Delivery [1 Minute]

      Result of singleton, twins, or other

    7. Neonatal APGARs [1 Minute]

      APGAR scores at 1 minute and minutes

    8. Neonatal Birthweight [1 Minute]

      Neonatal birthweight measured in grams

    9. Patient ASA Status [1 Minute]

      American Society of Anesthesiologists (ASA) physical status classification system ranging from 1 to 6

    10. Pregnancy Medical Conditions [1 Minute]

      Including: pregnancy induced HTN, pre-eclampsia, gestational diabetes, anemia, hyperemesis, cholestasis, and other.

    11. Medical Conditions Outside Pregnancy [1 Minute]

      Including any medical conditions that do not constitute a pregnancy medical condition

    12. Neuraxial Agents [1 Minute]

      Neuraxial agents and dosage administered prior and during the cesarean section procedure.

    13. Intraoperative Anxiolytics [1 Minute]

      Intraoperative anxiolytics drug and dose administered prior and during the cesarean section procedure.

    14. Anesthesia Procedure Start [1 Minute]

      Time in military time format

    15. Urgency of Cesarean Delivery [1 Minute]

      Classified as: scheduled, STAT, P1, or P2

    16. Indication for Cesarean Delivery [1 Minute]

      Reason for cesarean delivery

    17. Labour Onset [1 Minute]

      Indicated as: spontaneous, augmented, or induction of labour

    18. Labour Length [1 Minute]

      Length of hours for both first stage and second stage

    19. Pain Relief During Labour [1 Minute]

      Indicated as: epidural/CSE/DPE, Entonox, M&G, or other

    20. Intraoperative Complications [1 Minute]

      Indicated as: hypotension, shivering, nausea, vomiting, itch, failed neuraxial, or other.

    21. Intraoperative Blood Loss [1 Minute]

      Blood loss measured in milliliters.

    22. Postoperative Complications [1 Minute]

      Any medical complication indicated after the caesarean delivery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BC Women's Hospital Vancouver British Columbia Canada V6H 3N1

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Anthony Chau, Director of Research, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT05077891
    Other Study ID Numbers:
    • H21-01082
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 14, 2021