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Validation of the Chinese ObsQoR-11

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04349215
Collaborator
(none)
319
Enrollment
1
Location
24
Actual Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigation of post-cesarean recovery among Taiwanese pregnant women.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Improving postpartum quality of recovery is important particularly for women undergoing cesarean delivery. This is because cesarean delivery is associated with significant postoperative pain and risks of anesthesia-related adverse effects. To improve the quality of recovery after a cesarean delivery, the first step is to find out the most relevant perioperative factors.

    In response to this problem, experts including anesthesiologists, obstetricians and midwives from University College London Hospital, Royal Free Hospital, London as well as Stanford University established a set of 11-item questionaire related to postpartum recovery, namely the Obstetric Quality of Recovery-11 score (ObsQoR-11), with a total score of 110. The latest systemic review in 2020 also confirmed that this questionnaire is the best option for recovery assessment after cesarean delivery. However, for women undergoing cesarean delivery in Taiwan, it is still unknown whether this questionnaire is representative or not. Therefore, this study aims to include women undergoing elective cesarean delivery from three hospitals in Taiwan.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    319 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Validation of the Chinese Version of the Obstetric Quality of Recovery Scoring Tool (ObsQoR-11) at Early and Intermediate Phases After Elective Caesarean Delivery: a Multicentre Observational Trial
    Actual Study Start Date :
    Mar 9, 2020
    Actual Primary Completion Date :
    Mar 10, 2022
    Actual Study Completion Date :
    Mar 10, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Validation of the Chinese ObsQoR-11 score [5 days]

      To validate the Chinese ObsQoR-11 at 24 hour and 96 hour after cesarean delivery

    Secondary Outcome Measures

    1. Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11 [5 days]

      Perform analysis of reliability, acceptability, and responsiveness test for the Chinese ObsQoR-11

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    1. age>= 20 yr

    2. elective cesarean delivery

    Exclusion:

    emergent surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chun-Yu Wu, National Taiwan University Hospital; Cathay General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04349215
    Other Study ID Numbers:
    • 202002016RINC
    First Posted:
    Apr 16, 2020
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Apr 1, 2020
    Keywords provided by National Taiwan University Hospital
    Cesarean delivery,the Obstetric Quality of Recovery-11 score, Chinese

    Study Results

    No Results Posted as of Mar 28, 2022