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NCT Number: NCT04349215

Validation of the Chinese ObsQoR-11

Investigation of post-cesarean recovery among Taiwanese pregnant women.

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Key information

Conditions

Cesarean Delivery

Age range

20 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age>= 20 yr
  • elective cesarean delivery

Exclusion:

emergent surgery

Treatment and study plan

Primary outcomes

  1. Validation of the Chinese ObsQoR-11 score

    Time frame: 5 days

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

Secondary outcomes

  1. Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11

    Time frame: 5 days

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

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Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2020
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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