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

NCT04907292 | Completed

• 1 other identifier: 21-04
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Recovery

Keywords

Cesarean delivery; ObsQoR-10©

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours

  48 hours

• Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days

  7 days

• Pain Score (VAS) - 24 hours

  24 hours

• Pain Score (VAS) - 48 hours

  48 hours

• Opioid consumption - 24 hours

  24 hours

Study Arms (2)

Planned Cesarean delivery

Patients who have an elective Cesarean delivery at Mount Sinai Hospital

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

Unplanned Cesarean delivery

Patients who have an unplanned Cesarean delivery at Mount Sinai Hospital

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

Interventions

Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool OTHER

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.

Also known as: ObsQoR-10©

Planned Cesarean delivery; Unplanned Cesarean delivery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Study Officials

• Naveed Siddiqui, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: August 16, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 9, 2021
• Last Updated: January 31, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)