Validation of the Chinese ObsQoR-11

Completed

• Conditions: Cesarean Delivery

• Registration Number: NCT04349215
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Investigation of post-cesarean recovery among Taiwanese pregnant women.

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 Timeline

• Study Start: 2020-03-09
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 319

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan