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NCT04349215 Clinical Trial

Validation of the Chinese ObsQoR-11

Cesarean Delivery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04349215
Other study ID # 202002016RINC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date March 10, 2022

Study information
Verified date April 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigation of post-cesarean recovery among Taiwanese pregnant women.

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.

Recruitment information / eligibility
Status Completed
Enrollment 319
Est. completion date March 10, 2022
Est. primary completion date March 10, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 55 Years
Eligibility Inclusion criteria 1. age>= 20 yr 2. elective cesarean delivery Exclusion: emergent surgery

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of the Chinese ObsQoR-11 score To validate the Chinese ObsQoR-11 at 24 hour and 96 hour after cesarean delivery 5 days
Secondary Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11 Perform analysis of reliability, acceptability, and responsiveness test for the Chinese ObsQoR-11 5 days
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