Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10

Quality of Recovery Clinical Trial

Official title:

Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907292
• Other study ID #: 21-04
• Status: Completed
• Start date: August 16, 2021
• Est. completion date: November 9, 2021

Study information

• Verified date: September 2021
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 9, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Quality of Recovery

Intervention

Other:
• Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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.	48 hours
Secondary	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.	7 days
Secondary	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	24 hours
Secondary	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	48 hours
Secondary	Opioid consumption - 24 hours	Total opioid consumption within 24 hours post cesarean	24 hours
Secondary	Opioid consumption - 48 hours	Total opioid consumption within 48 hours post cesarean	48 hours
Secondary	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"	24 hours
Secondary	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"	48 hours