Cesarean DeliveryNCT04349215
Validation of the Chinese ObsQoR-11
An observational study of Cesarean Delivery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigation of post-cesarean recovery among Taiwanese pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Cesarean Delivery
- How many people
- 319 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2020to 10 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Post-cesarean delivery recovery
Who may be able to join
- age>= 20 yr
- elective cesarean delivery
Who cannot join
- emergent surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
Investigation of post-cesarean recovery among Taiwanese pregnant women.
Read the 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.
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean delivery,the Obstetric Quality of Recovery-11 score, Chinese
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Chinese ObsQoR-11 score
To validate the Chinese ObsQoR-11 at 24 hour and 96 hour after cesarean delivery
Measured: 5 days
Secondary outcomes (1)
Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11
Perform analysis of reliability, acceptability, and responsiveness test for the Chinese ObsQoR-11
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start9 Mar 2020
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital; Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349215
- Sponsor's protocol ID
- 202002016RINC
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04349215
- Acronym / sponsor ID
- 202002016RINC
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean delivery,the Obstetric Quality of Recovery-11 score, Chinese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Post-cesarean delivery recovery
Key inclusion criteria (2 listed)
- age>= 20 yr
- elective cesarean delivery
Key exclusion criteria (1 listed)
- emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu principal investigator
National Taiwan University Hospital; Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Delivery, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Chinese ObsQoR-11 score (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.