Quality of RecoveryNCT04907292
Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10
An observational study of Quality of Recovery, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery, compared to elective cesarean, may be associated with poor maternal recovery, longer postpartum hospital stays and more opioid… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2021to 9 Nov 2021
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who deliver by planned or unplanned cesarean section at Mount Sinai Hospital
Who may be able to join
- Women aged 18 years old and over
- Term singleton pregnancy
- Undergoing planned or unplanned caesarean delivery at Mount Sinai Hospital
- Patients who have given informed written consent
Who cannot join
- Patients who have refused, are unable to give or have withdrawn consent
- Patients unable to communicate fluently in English
- Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
- Patients scheduled to have a classical vertical incision
- Patients undergoing cesarean hysterectomy
- Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
- Patients who have refused neuraxial anesthesia, or those in whom it is contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery, compared to elective cesarean, may be associated with poor maternal recovery, longer postpartum hospital stays and more opioid requirements after surgery. Since the establishment of the Enhanced Recovery After Cesarean protocols, specific care pathways have been implemented with the aim of optimizing recovery after CD and to reduce the costs to the health care system. However, the majority of unplanned cesarean receive the same postoperative anesthetic, obstetric and nursing care as the elective CDs.
Looking at the actual information about maternal recovery after unplanned CD, the investigators found that there is a paucity of literature examining this topic utilizing validated, patient-oriented quality of recovery tools. Recently, Obstetric Quality of Recovery-10 scoring tool (ObsQoR-10), a new patient-focused outcome instrument for postpartum recovery, it has been validated for all types of deliveries, in the inpatient setting. ObsQoR-10 tool aims to measure quantitatively functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Read more
The aim of this study is to determine the quality of recovery from unplanned cesarean deliveries compared to planned ones using a validated tool for recovery after cesarean delivery (ObsQoR-10 tool).
The investigators hypothesize that quality of recovery as measured by the Obs-QoR10 for unplanned cesarean deliveries will be lower than the planned CDs.
- Conditions
- Quality of Recovery
- Being tested
- Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
- Keywords
- Cesarean delivery, ObsQoR-10©
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolOther
Also called ObsQoR-10©
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Planned Cesarean delivery | Patients who have an elective Cesarean delivery at Mount Sinai Hospital Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool | |
| Unplanned Cesarean delivery | Patients who have an unplanned Cesarean delivery at Mount Sinai Hospital Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
ObsQoR-10 score at 24 hours after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Measured: 24 hours
Secondary outcomes (8)
Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours
ObsQoR-10 score at 48 hours after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Measured: 48 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days
ObsQoR-10 score at 7 days after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Measured: 7 days
Pain Score (VAS) - 24 hours
Verbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 24 hours post cesarean delivery
Measured: 24 hours
Pain Score (VAS) - 48 hours
Verbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 48 hours post cesarean delivery
Measured: 48 hours
Opioid consumption - 24 hours
Total opioid consumption within 24 hours post cesarean
Measured: 24 hours
Opioid consumption - 48 hours
Total opioid consumption within 48 hours post cesarean
Measured: 48 hours
Hospital discharge - questionnaire, 24 hours
At 24 hours post cesarean, patients will be asked the question "Are you ready to be discharged from the hospital? Yes or No"
Measured: 24 hours
Hospital discharge - questionnaire, 48 hours
At 48 hours post cesarean, patients will be asked the question "Are you ready to be discharged from the hospital? Yes or No"
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start16 Aug 2021
- Primary completion2 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naveed Siddiqui, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907292
- Sponsor's protocol ID
- 21-04
- Status last verified
- Sep 2021
- First submitted
- 25 May 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10
- ClinicalTrials.gov ID
- NCT04907292
- Acronym / sponsor ID
- 21-04
- Conditions
- Quality of Recovery
- Keywords
- Cesarean delivery, ObsQoR-10©
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 28 May 2021 (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.
In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery, compared to elective cesarean, may be associated with poor maternal recovery, longer postpartum hospital stays and more opioid requirements after surgery. Since the establishment of the Enhanced Recovery After Cesarean protocols, specific care pathways have been implemented with the aim of optimizing recovery after CD and to reduce the costs to the health care system. However, the majority of unplanned cesarean receive the same postoperative anesthetic, obstetric and nursing care as the elective CDs.
Looking at the actual information about maternal recovery after unplanned CD, the investigators found that there is a paucity of literature examining this topic utilizing validated, patient-oriented quality of recovery tools. Recently, Obstetric Quality of Recovery-10 scoring tool (ObsQoR-10), a new patient-focused outcome instrument for postpartum recovery, it has been validated for all types of deliveries, in the inpatient setting. ObsQoR-10 tool aims to measure quantitatively functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
The aim of this study is to determine the quality of recovery from unplanned cesarean deliveries compared to planned ones using a validated tool for recovery after cesarean delivery (ObsQoR-10 tool).
The investigators hypothesize that quality of recovery as measured by the Obs-QoR10 for unplanned cesarean deliveries will be lower than the planned CDs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned Cesarean delivery | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who have an elective Cesarean delivery at Mount Sinai Hospital |
| Unplanned Cesarean delivery | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who have an unplanned Cesarean delivery at Mount Sinai Hospital |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who deliver by planned or unplanned cesarean section at Mount Sinai Hospital
Key inclusion criteria (4 listed)
- Women aged 18 years old and over
- Term singleton pregnancy
- Undergoing planned or unplanned caesarean delivery at Mount Sinai Hospital
- Patients who have given informed written consent
Key exclusion criteria (7 listed)
- Patients who have refused, are unable to give or have withdrawn consent
- Patients unable to communicate fluently in English
- Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
- Patients scheduled to have a classical vertical incision
- Patients undergoing cesarean hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolAlso: ObsQoR-10©The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient. | Other | Planned Cesarean delivery, Unplanned Cesarean delivery |
Primary outcome
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Time frame: 24 hours
ObsQoR-10 score at 24 hours after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
8 secondary outcomes
Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours
Time frame: 48 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days
Time frame: 7 days
Pain Score (VAS) - 24 hours
Time frame: 24 hours
Pain Score (VAS) - 48 hours
Time frame: 48 hours
Opioid consumption - 24 hours
Time frame: 24 hours
Opioid consumption - 48 hours
Time frame: 48 hours
Hospital discharge - questionnaire, 24 hours
Time frame: 24 hours
Hospital discharge - questionnaire, 48 hours
Time frame: 48 hours
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 31 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Naveed Siddiqui, MD principal investigator
MOUNT SINAI 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 Quality of Recovery, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 4 inclusion and 7 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 31 Jan 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 Canada. 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?
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours (time frame: 24 hours). 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 31 Jan 2022.