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

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 Overview

• Status: Completed
• Conditions: Quality of Recovery
• Intervention / Treatment: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver by planned or unplanned cesarean section at Mount Sinai Hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Planned Cesarean delivery; Patients who have an elective Cesarean delivery at Mount Sinai Hospital	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.; Other Names: ObsQoR-10©
Unplanned Cesarean delivery; Patients who have an unplanned Cesarean delivery at Mount Sinai Hospital	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.; Other Names: ObsQoR-10©

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Opioid consumption - 24 hours	Total opioid consumption within 24 hours post cesarean	24 hours
Opioid consumption - 48 hours	Total opioid consumption within 48 hours post cesarean	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"	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"	48 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Naveed Siddiqui, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cesarean delivery; ObsQoR-10©
• Other Study ID Numbers: 21-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No